Testing oral health device efficacy

Abstract

Methods and systems to analyze the efficacy of an oral health device. The method includes impinging an efficacy media with an output of the oral health device. Then, analyzing the impinged efficacy media to identify an efficacy value of the oral health device based on the impinged efficacy media.

Description

Docket No. P325815.WO.01TESTING ORAL HEALTH DEVICE EFFICACYCROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to U.S. Provisional Application No. 63 / 762,559, filed February 24, 2025, entitled “TESTING ORAL HEALTH DEVICE EFFICACY,” which is incorporated herein in its entirety for all purposes.BACKGROUND

[0002] While many people use different types of oral health devices, such as toothbrushes, oral irrigators, or combination brushing and flossing devices, it can be difficult to empirically determine the efficacy and / or performance levels of such devices. For example, testing the ability of an oral health device to remove plaque or provide increased cleaning as compared to conventional devices may require extensive clinical trials with numerous patients subjected to different cleaning parameters and the like. Because such testing is difficult, expensive, and takes many months if not years, product development can be hindered. Additionally, device parameters may not be readily corresponded to efficacy or performance levels.BRIEF SUMMARY

[0003] In one embodiment, a method to determine efficacy of an oral health device is disclosed herein. The method includes impinging an efficacy media with an output of the oral health device, and identifying an efficacy value of the oral health device by analyzing the impinged efficacy media.

[0004] Optionally, in some embodiments, the method includes configuring a test assembly, wherein the oral health device and the efficacy media are removably coupled to the test assembly, and the test assembly defines a set position between the oral health device and the efficacy media, and preparing the efficacy media by one or more of drying the efficacy media, or housing the efficacy media in a dark room.

[0005] Optionally, in some embodiments, the impinged efficacy media has portions removed by the impingement and the portions removed determines the efficacy value.

[0006] Optionally, in some embodiments, a difference between an area of the efficacy media before impinging and an area of the impinged efficacy media determines the efficacy value.14936-3423-502511Docket No. P325815.WO.01

[0007] Optionally, in some embodiments, the testing assembly defines a fixed gap from 0.1 mm to 3.0 mm between the oral health device and the efficacy media.

[0008] Optionally, in some embodiments, the efficacy media includes a substrate and at least one layer of a selectively removable material.

[0009] Optionally, in some embodiments, the efficacy media includes at least one layer of a colored gel.

[0010] Optionally, in some embodiments, the method further includes performing a first pass analysis, wherein the efficacy media affected by one or more of a manufacturing error or a testing error is removed from the method and the efficacy value is not identified.

[0011] Optionally, in some embodiments, the oral health device is an oral irrigator and / or an electric toothbrush.

[0012] In one embodiment, a method to analyze the efficacy of an oral health device based on an efficacy value is disclosed herein. The method includes receiving a data set of efficacy media impinged by an output of an oral health device, and analyzing, by a processor, the efficacy value of the dataset of impinged efficacy media.

[0013] Optionally, in some embodiments, the method includes converting the data set having a plurality of pixels including color variations to a binary dataset of black and white pixels, and analyzing the converted dataset to determine the efficacy value, wherein the dataset is presented to a user to convert the dataset to the binary dataset via a user interface.

[0014] Optionally, in some embodiments, the processor determines the efficacy value based on one or more of a height of the total area analyzed, a width of the total area analyzed, a percent of black pixels of the dataset, and / or a percent of white pixels of the dataset.

[0015] Optionally, in some embodiments, the method includes enhancing efficacy media by positioning a background behind the efficacy media.

[0016] Optionally, in some embodiments, the method includes a first pass analysis of the efficacy media to filter the efficacy media including an error.

[0017] Optionally, in some embodiments, an image sensor generates the data of the efficacy media as an image of the efficacy media.

[0018] Optionally, in some embodiments, the processor analyzes the image of the efficacy media on a pixel by pixel basis.24936-3423-5025UDocket No. P325815.WO.01

[0019] Optionally, in some embodiments, the processor converts the image of the efficacy media to a binary image.

[0020] In one embodiment, a system to test the efficacy of an oral health device is disclosed herein. The system includes a test assembly with a test fixture, wherein the oral health device and an efficacy media are configured to be removably coupled to the test fixture, a data generating assembly including a sensor to generate a data of the efficacy media, an efficacy media fixture, wherein the sensor removably couples to the sensor fixture, and the efficacy media removably couples to the efficacy media fixture, and an analysis assembly including a processor to determine an efficacy value of the oral health device, and a user interface.

[0021] Optionally, in some embodiments, the sensor is an image sensor and the data generated is an image.

[0022] Optionally, in some embodiments, the efficacy media of the system includes a substrate and at least one layer of a selectively removable material.

[0023] Optionally, in some embodiments, the efficacy value is based on difference between a first area of the at least one layer of the selectively removable material and a second area of the selectively removable material.

[0024] Optionally, in some embodiments, the efficacy value is based on difference between a first height of the at least one layer of selectively removable material and a second height of the at least one layer of selectively removable material.

[0025] Optionally, in some embodiments the efficacy media of the system includes at least one layer of a colored gel.

[0026] In one embodiment, a method to determine efficacy of an oral health device is disclosed herein. The method includes analyzing a captured image of an efficacy media impinged by a fluid stream ejected by the oral health device, identifying a removed portion of the efficacy media, generating an efficacy indication based on the removed portion.BRIEF DESCRIPTION OF THE DRAWINGS

[0027] FIG. 1 is a simplified schematic of an example system.

[0028] FIG. 2 is a flow chart of an example method to test oral health care devices with the example system of FIG. 1.

[0029] FIG. 3 is a flow chart of an example method to capture data with the example system of FIG. 1.34936-3423-502511Docket No. P325815.WO.01

[0030] FIG. 4 is a flow chart of an example method to analyze the data of the efficacy media with the system of FIG. 1.

[0031] FIG. 5 is an image of an example efficacy media to be used in the system of FIG. 1.

[0032] FIG. 6 is an image of an example test assembly of the system of FIG. 1.

[0033] FIG. 7 is an image of an example test fixture and oral health care device of the system in FIG. 1.

[0034] FIG. 8 is an image of an example test fixture and oral health care device of the system in FIG. 1.

[0035] FIG. 9 is an image of an example data capture assembly of the system of FIG. 1.

[0036] FIG. 10A is an image of an example efficacy media rejected for data capture.

[0037] FIG. 10B is an image of the opposite side of the example efficacy media shown in FIG.10A.

[0038] FIG. 11A is another image of an example efficacy media rejected for data capture.

[0039] FIG. 1 IB is an image of the opposite side of the example efficacy media shown in FIG. HA.

[0040] FIG. 12 is another image of an example efficacy media rejected for data capture.

[0041] FIG. 13 is an image of an example efficacy media prepared for data capture.

[0042] FIG. 14A is another image of an example efficacy media prepared for data capture with two background colors.

[0043] FIG. 14B is an image of the example efficacy media in FIG. 14A prepared with a black background.

[0044] FIG. 14C is an image of the example efficacy media in FIG. 14A prepared with a red background.

[0045] FIG. 15 are images of an example backgrounds used with data capture and an example of efficacy media with a red background.

[0046] FIG. 16 is an image of an example of efficacy media coupled to an efficacy media fixture.

[0047] FIG. 17 is another image of an example efficacy media coupled to an efficacy media fixture.

[0048] FIG. 18 is an image of an example efficacy media prepared for data capture.44936-3423-502511Docket No. P325815.WO.01

[0049] FIG. 19 is another image of examples of efficacy medias prepared for data capture.

[0050] FIG. 20 are images of example prepared efficacy test medias with different colored backgrounds.

[0051] FIG. 21 A is an image of an example data capture fixture of the system in FIG. 1.

[0052] FIG. 2 IB is an image of an example data capture device positioned on the data capture fixture of FIG. 21 A.

[0053] FIG. 22 is an image of an example of efficacy media data being prepared for analysis.

[0054] FIG. 23 is an image of an example of efficacy media data being prepared for analysis.

[0055] FIG. 24 is an image of an example of efficacy media data being prepared for analysis.

[0056] FIG. 25 is an image of an example software tool to prepare efficacy media data for analysis.

[0057] FIG. 26 is an image of an example of efficacy media data being prepared for analysis.

[0058] FIG. 27 is an image of an example of efficacy media data being prepared for analysis.

[0059] FIG. 28 is an image of an example of efficacy media data being prepared for analysis.

[0060] FIG. 29 is an image of an example software tool to prepare efficacy media data for analysis.

[0061] FIG. 30 is an image of an example of efficacy media data being prepared for analysis.

[0062] FIG. 31 is an image of an example of efficacy media data being prepared for analysis.

[0063] FIG. 32 is an image of an example of efficacy media data being prepared for analysis.

[0064] FIG. 33 is an image of an example of efficacy media data being prepared for analysis.DETAILED DESCRIPTION

[0065] The following disclosure includes systems and methods to efficiently and reliably test the efficacy of oral health devices, as well as understand performance metrics or levels for different operational parameters, such as pump speed, pulse rate, etc. Such performance metrics have not been easily determined in conventional methods. In various examples, the system includes an efficacy media that can be exposed to the operation of the oral health device, e.g., the fluid expelled by an oral irrigator. The physical properties of the efficacy media change in response to the output oral health care device and such changes are captured and analyzed. The changes can be correlated to performance of the device and efficacy. For example, the efficacy media may include layers with different detectable characteristics (e.g., different colors or 54936-3423-502511Docket No. P325815.WO.01 textures) that are removed in response to a physical force, such as the force output by the oral health device. As another example, the efficiency media may include a single substrate behind a background or secondary material having a different color or characteristic that can be identifiable via a computer analysis.

[0066] The system captures data related to the physical changes to the efficacy media during the exposure to the cleaning device or system. For example, the system can capture images of the efficacy media before, during, and after exposure to different oral health devices or devices operating under different conditions. The images or other captured data are analyzed to determine areas of changed characteristics under the different testing conditions, e.g., ablated or removed sections of the media or the like. Using the analysis, the operational efficacy of the various devices under different operating parameters can be determined. In some instances, the testing configuration may include procedures to help reduce error or changes between different tests, e.g., allows repeatable and reliable data capture.

[0067] Software operating on a processing element or computer may be used to make calculations and comparisons regarding the efficacy of the oral health device. For example, various algorithms executed by processing elements (e.g., via software instructions) can be used to indicate the efficacy of tested oral health devices. An efficacy value, such as a relative area removed, and / or optionally depth, of the efficacy media the output of an oral health device has exposed, e.g., removed via the fluid force, may indicate efficacy of the oral health device. The efficacy value may be a range, a ranking, a number, or other types of identifiers. The efficacy removal value can be analyzed to identify efficacy of different oral health devices or different operating conditions. The example, changes to the physical properties of the efficacy media may indicate an increase or decrease in performance.

[0068] For example, the system may be used to test an oral irrigator's plaque removal efficacy. The test fixture secures the position of the oral irrigator relative to the efficacy media. The oral irrigator is then operated such that the fluid stream impinges on an efficacy media. After the oral irrigator ends operation, images are captured of the efficacy media after exposure to the fluid stream. The images are analyzed to identify the relative efficacy of the particular operating parameters and device in removing the efficacy media, e.g., the more media removed, the more plaque may be able to be removed with the same device or operating parameters. Other characteristics of the media removal, such as depth, area, and geometric shape may be64936-3423-5025UDocket No. P325815.WO.01 analyzed as well to further determine efficacy of different cleansing systems, parameters, or the like.

[0069] In various embodiments, the system may include efficacy media along a single plane, which may help to provide consistent and repeatable results across a variety of oral irrigator devices.

[0070] Turning to the figures, FIG. 1 shows a simplified schematic of an example of a system 100 used to test the efficacy of an oral health device using an efficacy media. The system 100 comprises a test assembly 102, a data generation assembly 110, and an analysis assembly 118. It should be noted that in any example, the system 100 may include fewer or more of the various assemblies and the functionality of any of the assemblies may be incorporated into others, e.g., the data generation assembly 110 may be included with the test assembly 102 and / or analysis assembly 118. The test assembly 102 includes an oral health device 104, an efficacy media 108, and a test fixture 106.

[0071] The oral health device 104 is generally any type of oral cleaning implement, such as an electric toothbrush, oral irrigator, and / or combination unit. In many examples, the oral health device 104 is an oral irrigator that expels a stream of fluid (e.g., water, salt water, mouthwash, antimicrobial solutions, etc.) via a pump. In these examples, the fluid stream acts to remove plaque from a user’s teeth. The test assembly 102 may then test the efficacy of the fluid stream ejected by an oral irrigator, which may vary based on the type of pump and motor of the oral health device, as well as different operating parameters (e.g., settings or changes to the pressure, pump rate, etc.).

[0072] The efficacy media 108 is generally a substrate with at least one layer of a selectively removable material. The substrate may be a sheet of paper, plastic, or a combination of both. The substrate may be transparent, although opaque materials may also be used. The selectively removable material is a material that deforms or moves upon being impinged, such as with an impact force, which may be caused by a fluid ejected from an oral irrigator, and / or bristle scrubbing. In some embodiments, the selectively removable material is hygroscopic. In some examples, the at least one layer of selectively movable material includes a white media layer and / or a black media layer. In these examples, the white media layer may be positioned in between and coupled to both the substrate and the black media layer. The difference in color may be visual. For example, an impact force may disturb the black media layer and expose the white media layer. The impact force may also disturb the white media layer, exposing the 74936-3423-5025\lDocket No. P325815.WO.01 substrate. Complete Media Removal (CMR) may be the area where all black and white media is removed from the substrate. In these examples, the efficacy media 108 may be used to test the efficacy of the oral health device 104, which may vary based on the type of pump and motor of the oral health device, as well as different operating parameters (e.g., settings or changes to the pressure, pump rate, etc.).

[0073] In some embodiments, the efficacy media 108 includes an efficacy fluid. For example, the efficacy fluid may be a gel. In some embodiments, the efficacy fluid hardens on the substrate. For example, the efficacy fluid may be positioned on the substrate, then harden over a duration of time to a desired hardness before efficacy testing. Fluid ejected from an oral irrigator and / or force from bristles may impinge on the efficacy fluid. The amount of the efficacy fluid removed from the substrate may be used to determine an efficacy of the oral health device 104. In some embodiments, the efficacy fluid may be colored. The color of the efficacy fluid may contrast from the color of the substrate to distinguish the two components for analysis. For example, the efficacy fluid may be a black gel and the substrate may be white in color. In some embodiments, the physical properties (e.g., hardness, thickness, flow properties, etc.) of the efficacy fluid may simulate plaque, food debris, tartar, and the like.

[0074] In other examples, other types of materials may be used for the efficacy media, such as pastes, solids, or the like. The efficacy media should have a hardness and removal characteristics that match or are substantially similar to plaque and other debris positioned on teeth or other oral elements. This allows the system to be able to test the removal / changes in the efficacy media and have an understanding of how those removal / changes would apply to real plaque and better characterize performance of a given oral health device. As such, the discussion of any particular efficacy media is meant to be illustrative only as a variety of different substances and detectable characteristics (e.g., hue, brightness, depth, or the like) that may be changed upon impingement of a fluid force and can be detected by one or more sensors and analyzed by a computer system.

[0075] The test assembly 102 configures the oral health device 104, the efficacy media 108, and the test fixture 106 to provide consistent and reliable test results, resulting in accurate characterizations of the oral health device 104. The consistent testing environment ensures tests experiments can be repeated across a number of variables, such as type or operating conditions of the oral health device 104. For example, the test assembly 102 may configure a constant relationship, such as distance and / or spacing, between the various components across different 84936-3423-5025\lDocket No. P325815.WO.01 tests. The test fixture 106 provides a stable structure to receive and removably couple to the oral health device 104 and the efficacy media 108 to which they are secured in place by. The test fixture 106 positions the oral health device 104 relative to the efficacy media 108 so that an output from the oral health device 104 impinges the efficacy media 108. For example, the test fixture 106 may position an electric toothbrush so the bristles scrub the efficacy media 108 when operated. The spacing is generally set to be at a distance that would simulate real world use by a user, e.g., about the distance that a user holds the oral health device to their teeth. For example, the oral health device 104 may be spaced about 0.0 mm to 15.0 mm from the efficacy media 108.

[0076] The data generation assembly 110 includes a sensor 112, a sensor fixture 114, and an efficacy media fixture 116. The data generation assembly 110 generates a data corresponding to the physical properties of the efficacy media 108. Similar to the test assembly 102, the data generation assembly 110 provides consistent and reliable results. For example, the data generation assembly 110 may configure a constant relationship, such as distance and / or spacing, between the various components across different tests. The sensor fixture 114 provides a stable structure to receive and removably couple to the sensor 112 and the efficacy media 108 to which they are secured in place by. The sensor 112 generates data corresponding to the physical properties of the efficacy media 108. For example, the sensor 112 may record digital images of the efficacy media 108. In some embodiments, the sensor 112 is a camera. The data generated by the sensor 112 can be analyzed to provide insights into the characterization of the oral health device 104. For example, an image produced by a camera can be analyzed to determine an oral irrigator's effectiveness in removing plaque. In some embodiments, the sensor 112 is integrated in the data generation assembly 110. The integration may ensure consistency in the data generation. For example, the spacing / distance between the sensor 112 and the efficacy media 108 may be set so the data generation, such as image capture, is consistent across different tests.

[0077] In some embodiments, the efficacy media 108 removably couples to the sensor fixture 114. For example, the efficacy media 108 may couple to the sensor fixture 114 using fasteners. The fasteners may include one or more of clamps, clips, or the like. In other embodiments, the efficacy media 108 may couple to the sensor fixture 114 without using clamps. For example, the sensor fixture 114 may define a slot or aperture to secure the position of the efficacy media 108.94936-3423-502511Docket No. P325815.WO.01

[0078] In some embodiments, the efficacy media 108 couples to an efficacy media fixture 116 before coupling to the sensor fixture 114. The efficacy media fixture 116 provides a framework or structure to consistently align the position of the efficacy media 108 relative to the position of the sensor 112 across different tests. For example, the efficacy media fixtures 116 may define an aperture to receive the efficacy media 108. Once received, the efficacy media fixture 116 may couple to the sensor 112 so that the efficacy media 108 is in a first orientation with respect to the sensor 112. The efficacy media fixture 116 allows the efficacy media 108 from different tests to be positioned in the first orientation with respect to the sensor 112. In some embodiments, the efficacy media fixture 116 may define an alignment protrusion or alignment aperture that receives or is received by a corresponding feature of the sensor fixture 114. For example, the sensor fixture 114 may define an aperture configured to receive a protrusion defined by the efficacy media fixture 116. Once coupled together, the features of the efficacy media fixture 116 and the sensor fixture 114 consistently align the efficacy media 108 with the sensor 112.

[0079] The analysis assembly 118 includes a processor 120 and a user interface 122. A user may analyze the data from the data generation assembly 110 with the processor 120 and the user interface 122. The processor 120 analyzes data efficiently and in detail. The user interface 122 allows a user to interact with the processor 120. The processor 120 may use software to analyze the generated data and measure even minute changes to the efficacy media 108, resulting in better / more accurate characterizations of the oral health device 104. For example, if the generated data is a digital photograph, the processor 120 may analyze the digital photograph on a pixel by pixel basis, providing insights to the efficacy of the oral health device 104. In some embodiments, the processor 120 is coupled to the sensor 112.

[0080] FIG. 2 is a flow chart of an example method 200 to test the efficacy of an oral health device. For example, the oral health device 104 may be tested for efficacy in removing plaque, removing food, dental massaging, etc. Although the example method 200 depicts a particular sequence of operations, the sequence may be altered without departing from the scope of the present disclosure. For example, some of the operations depicted may be performed in parallel or in a different sequence that does not materially affect the function of the method 200. In other examples, different components of an example device or system that implements the method 200 may perform functions at substantially the same time or in a specific sequence.104936-3423-5025\lDocket No. P325815.WO.01

[0081] Optionally, the method 200 may begin by configuring the test assembly 102 at operation 202. Configuring the test assembly 102 may include positioning the oral health device 104 and the efficacy media 108 using the test fixture 106. Tn order to provide statistically reliable results, the position of the oral health device 104 for each test should be consistent. Operation 202 may include coupling the oral health device 104 to the test fixture 106 and adjusting the position of the oral health device 104 relative to the efficacy media 108. Fasteners, such as clamps, may couple the oral health device 104 to the test fixture 106. A user may adjust the position of the oral health device 104 using the fasteners. A distance between the oral health device 104 and the efficacy media 108 may be adjusted by manipulating the connection between the fastener coupling the oral health device 104 to the test fixture 106.

[0082] In some embodiments, the operation 202 may include coupling the oral health device 104 to the test fixture 106 to define a gap between the oral health device 104 and the efficacy media 108. In some embodiments, the gap may be 1.0 mm to 1.5 mm. In some embodiments, the gap may be .01 mm to 3.0 mm. In some embodiments, the gap may be substantially 0.0 mm. For example, the gap between an oral health device 104 using bristles and the efficacy media 108 may be substantially 0.0 mm so the bristles may contact the efficacy media 108. In some embodiments, the gap is determined by the type of oral health device. For example, testing an electric toothbrush would involve physical contact between the bristles and the efficacy media 108, whereas testing an oral irrigator may involve a gap between the tip of the irrigator and the efficacy media 108.

[0083] In some embodiments, the operation 202 includes configuring the test assembly 102 so that the oral health device 104 may move during experimentation. The oral health device 104 may simulate actual use scenarios if configured to move during experimentation. For example, the configuration of the test assembly 102 may simulate hand movements of users during experimentation. These configurations may include rotating the oral health device 104 and / or moving the oral health device 104 along a plane relative to the efficacy media 108. For example, the test fixture 106 may rotate the oral health device 104 along the radial axis. Radial rotation may simulate a user's motion when using the oral health device 104 and may provide accurate results corresponding to real world use of the device.

[0084] In some embodiments, the operation 202 includes configuring the test assembly 102 so that the oral health device 104 does not move, or does not substantially move, during experimentation. The test fixture 106 fixes the position of the oral health device 104 in a 114936-3423-502511Docket No. P325815.WO.01 consistent manner (e.g., at the same distance, angular orientation, etc.) so that any test produces reliable and reproducible results for analysis. The oral health device 104 may couple to the test fixture 106 using fasteners. For example, the oral health device 104 may couple to the test fixture 106 using clamps, vices, bolts, screws, or the like.

[0085] In some embodiments, the operation 202 may include securing the position of the efficacy media 108. The test fixture 106 fixes the position of the efficacy media 108 in a consistent manner (e.g., at the same distance, angular orientation, etc.) so that any test produces reliable and reproducible results for analysis. The efficacy media 108 may couple to the test fixture 106 using fasteners. For example, the efficacy media 108 may couple to the test fixture 106 using clamps, clips, or the like. In other embodiments, the efficacy media 108 may couple to the test fixture 106 without using clamps. For example, the test fixture 106 may define a slot or aperture to secure the position of the efficacy media 108.

[0086] Optionally, the method 200 may include operation 204 to prepare the efficacy media. The preparation may depend on the type of oral health device 104 or characteristic being tested. For example, testing the ability of an electric toothbrushes to remove plaque may use one method of preparing the efficacy media 108, whereas testing the plaque removing ability of an oral irrigator may use a different method of preparing the efficacy media 108.

[0087] In some embodiments, the operation 204 includes a user washing or wiping their hands before securing the position of the efficacy media 108. The washing or wiping removes substances from the user's hands that may affect the efficacy media 108. For example, oils or lotions on the hands of the user may change the properties of the efficacy media 108, such as water absorption, and interfere with the test.

[0088] In some embodiments, the operation 204 may include pre-wetting the efficacy media 108. Pre-wetting may be required depending on the selectively removable material of the efficacy media 108. For example, the selectively removable material may require pre-wetting to simulate the properties of plaque. Various methods may be used to pre-wet the efficacy media 108. For example, water may be applied via a dropper or a spray onto the efficacy media 108. The operation 204 that includes pre-wetting may standardize the amount of fluid used and the amount of time the efficacy media 108 soaks in the pre-wetting fluid. The amount of time used for pre-wetting may vary depending on the type of test conducted and the type of efficacy media 108 used. For example, layered paper efficacy medias may pre-wet for up to 10 seconds, using a minimum amount of fluid to completely saturate the selectively removable material of 124936-3423-5025\lDocket No. P325815.WO.01 the efficacy media 108. The fluid amount used to pre-wet, and / or the soak time may affect the amount of the selectively removable material impinged by the oral health device 104 during the operation 206. Standardizing the fluid amount and soaking time ensures consistent testing environments during the operation 206, leading to reproducible results across tests. For example, different settings of the oral health device 104 may be selected and tested during the operation 206. A standardized pre-wetting operation allows the different settings to be tested using consistent test environments, i.e., the efficacy media 108 behaves in the same or substantially the same manner in different tests.

[0089] The method 200 includes operation 206 to impinge the efficacy media 108 with the oral health device 104 via an output from the oral health device 104. The output may include a physical force produced from the oral health device 104. For example, the oral health device 104 may be an oral irrigator and the output may be fluid ejected from the oral irrigator. In this example, a motor of the oral irrigator may activate, engaging a pump to eject fluid from a tip of the oral irrigator. In another example, the output may be the physical force applied by the bristles of an electric toothbrush. In this example, a motor may activate, moving bristles in mechanical communication with the motor. The output may affect a physical property of the efficacy media 108, allowing characterization of the oral health device 104. For example, the expelled fluid from an oral irrigator may impinge the efficacy media 108, and the factors controlling the fluid may be tested, e.g., the motor type, diameter of the aperture the fluid is expelled from, etc. In another example, an electric toothbrushes may impinge the efficacy media 108 by scrubbing the efficacy media 108 with bristles. The factors controlling characteristics of the scrubbing may be tested, e.g., the motor type, the motor speed, bristle type, etc. Other factors affecting the impinging may include, and are not limited to, battery life, motor speed, volumetric flowrates, fluid pressure, etc.

[0090] As the oral health device 104 may include multiple settings, some embodiments of the operation 206 may include choosing a setting of the oral health device 104. For example, the oral health device 104 may be an oral irrigator with a plurality of operating modes, such as a normal mode, a low pressure setting, a high pressure setting, and / or a massage mode. In such examples, the operation 206 may include selecting one of the modes / settings, such as normal mode. The operations 206 may be repeated to test other modes or configurations of the oral health device 104. For example, in one instance, a normal mode of the oral health device 104 may be selected in the operation 206 , and in another instance, a massage mode of the oral 134936-3423-502511Docket No. P325815.WO.01 health device 104 may be selected in the operation 206. Different devices may have different operating characteristics. For example, an oral irrigator may have settings that affect the force, or flow pattern of the fluid ejected. Tn another example, an electric toothbrush may have settings that affect the speed of the bristle movement.

[0091] In some embodiments, the operation 206 includes selecting an operating time to operate the oral health device 104. Depending on the efficacy media 108, the oral health device 104 may be operated for varying amounts of time. The operating time may be selected so that the oral health device 104 impinges the efficacy media 108. The operating time may also be selected so that the change in physical properties in the efficacy media 108 can be differentiated across different tests (e.g., if the oral health device 104 is operated for too long, the selectively removable layers of the efficacy media 108 may be completely removed and no meaningful test data can be obtained). For example, the efficacy media 108 may be configured to simulate plaque. In this example, the oral health device 104 may be operated for about 1 second, about 2 seconds, about 3 seconds, about 4 seconds, or about 5 seconds. The operating mode of the oral health device 104 may also affect operation time. For example, oral irrigators may be operated for 3 seconds at high pressure settings, or for 5 seconds at low pressure settings. The operation 206 may conclude when the operation of the oral health device 104 terminates.

[0092] The method 200 may then proceed to identify an efficacy value in operation 208. The efficacy value is a metric based on the physical condition of the efficacy media 108. The efficacy value may be a range, a ranking, a number, or other types of an identifier to indicate the efficacy of the tested oral health device. For example, the efficacy value may be the area of selectively removable material removed from the efficacy media 108. A portion of the layer of selectively removable material may be disturbed by the oral health device 104 in the operation 206. The amount of material disturbed may be used to determine the efficacy of the oral health device 104 to remove plaque. The amount may be represented by the difference in area of selectively removable material of the efficacy media 108 before and after impinging with the oral health device 104.

[0093] In some embodiments, the efficacy value may be determined by a depth between a first height and a second height of the efficacy media 108. For example, the depth may be used to characterize the ability of the oral health device 104 to penetrate plaque. The penetration caused by impinging the efficacy media 108 with the oral health device 104 in the operation 144936-3423-502511Docket No. P325815.WO.01 206 may determine the depth. For example, the oral health device 104 may be an oral irrigator that ejects fluid to disturb the selectively removable material of the efficacy media 108. A total height between the selectively removable material and the substrate before the operation 206 may determine the first height. A height between the selectively removable material and the substrate after the operation 206 may determine the second height. The difference between the first height and the second height may determine the depth used as the efficacy value.

[0094] FIG. 3 is a flow chart of an example method 300 to generate data from the efficacy media and to analyze the generated data. Although the example method 300 depicts a particular sequence of operations, the sequence may be altered without departing from the scope of the present disclosure. For example, some of the operations depicted may be performed in parallel or in a different sequence that does not materially affect the function of the method 300. In other examples, different components of an example device or system that implements the method 300 may perform functions at substantially the same time or in a specific sequence.

[0095] Optionally, the method 300 may begin by preparing the efficacy media 108 for data capture at operation 302. After the efficacy media 108 has been impinged on by the oral health device 104, for example in operation 206 of the method 200, the efficacy media 108 may be processed to reduce variability due to procedure that may skew data analysis, so that the data generated from the efficacy media 108 is consistent and reliable across different tests. In some embodiments, operation 302 may include drying the efficacy media 108. For example, if oral irrigators are tested for plaque removing using oral irrigators, then the efficacy media 108 will be wet with fluid ejected from an oral irrigator, such as water, mouthwash, saltwater, etc., after testing. The efficacy media 108 may retain different amounts of liquid for each test performed, which may skew data analysis. Drying the efficacy media 108 would remove the variability caused by the wetness, and a user may obtain reliable results. In some embodiments, the efficacy media 108 may dry for up to 24 hours. In some embodiments, the efficacy media 108 completely dries before proceeding. In some embodiments, operation 302 may include subjecting the efficacy media 108 may be subject to certain environments with or without light. For example, the efficacy media 108 may be housed in a dark room to prevent light from contacting the efficacy media.

[0096] Operation 302 may also include a first pass analyzing the efficacy media 108. The efficacy media 108 may not accurately reflect the efficacy of the oral health device 104 since the efficacy media 108 may include testing errors and / or manufacturing errors. The first pass 154936-3423-5025\lDocket No. P325815.WO.01 analysis may filter out the efficacy media 108 with results affected by these errors. For example, the efficacy media 108 may form a bubble between the selectively removable material and the substrate due to a manufacturing error. An output from an oral health device 104 may impinge the efficacy media 108 with a bubble differently than if the efficacy media 108 did not include a bubble. The first pass analysis would visually inspect the efficacy media 108 for a bubble, and remove the efficacy media 108 from the methods 300 if a bubble is detected.

[0097] In some embodiments, operation 302 may include enhancing the efficacy media 108. The efficacy media 108 may be enhanced to by generally providing a contrast so the data generated, as described below, may include more detail and / or provide additional information, such as during data generation or analysis. In some embodiments, the operation 302 may include positioning a colored background behind, or under, the efficacy media 108, and the color of the background may depend on the type of analysis. For example, a black background may be used to determine the ability of the oral health device 104 to remove all layers of the efficacy media 108. A red background may be used to provide a visual reference to compare the performance of the oral health device 104. A white background may be used to provide a contrast to the color of the top layer of the efficacy media 108. The colored background may be provided by colored paper, plastic sheets, or display. In some embodiments, a light source enhances the efficacy media 108. In some embodiments, a colored light source enhances the efficacy media 108. In some embodiments, enhancing the efficacy media 108 includes positioning a colored background behind the efficacy media 108 and backlighting with a light source.

[0098] Optionally, the method 300 may include operation 304 to configure the data generation assembly 110. The data generation assembly 110 is configured to align the positions of the efficacy media 108 and the sensor 112 using the sensor fixture 114. Alignment may include fixing a distance and orientation between the efficacy media 108 and the sensor 112. For example, the sensor 112 may be a camera and the operation 304 may include fixing the distance between the camera and the efficacy media 108 along the longitudinal axis as the camera lens so that the center of the efficacy media 108 is centered with the camera lens. The same distance and orientation may then be used across different tests.

[0099] In some embodiments, operation 304 may include configuring the sensor 112. For example, operation 304 may include selecting settings of the sensor 112. If the sensor 112 is a camera, the settings selected may include, but are not limited to, aperture settings, flash, zoom,164936-3423-502511Docket No. P325815.WO.01 focus, color settings, stability, or field of view choices. In some embodiments, configuring the sensor 112 may be omitted, as the sensor may be pre-calibrated, and / or configuration in operation 304 as described above obviates the need to configure the sensor 112.

[0100] The method 300 includes operation 306 to generate data from the efficacy media 108. For example, if the sensor 112 is a camera, operation 306 is performed by capturing an image of the efficacy media 108.

[0101] After generating data from the efficacy media 108 in the operation 306, the method 300 may proceed to operation 308 and transmit the efficacy media data, generally to the processor 120. In some embodiments, the operation 308 may include uploading the efficacy media data to the processor 120. In some embodiments, the data transmits via electronic communication. For example, the processor 120 and the sensor 112 may be coupled via wires, such as an ethernet cable. In some embodiments, the data transmits via a wireless network. For example, the sensor 112 may send a signal via a wireless network. The processor 120 may include a receiver to receive and download the signal. In some embodiments, the processor 120 may store the data in readable storage medium. For example, the processor 120 may store the data in computer memory stored in a drive, or a memory card.

[0102] Once the efficacy media data transmits in the operation 308, the method 200 may proceed to the operation 310 to analyze the efficacy media data. Generally, the operation 310 is similar to the operation 208 in that the operation 308 determines an efficacy value, as described herein. The efficacy value may be a range, a ranking, a numerical value, or other types of an identifier. For example, the efficacy value may be an area of the selectively removable material removed from the efficacy media 108, or a depth of between a first height and a second height of the efficacy media 108. Once identified, the efficacy value may be used to characterize the oral health device 104. For example, the efficacy value may be a metric representing the ability of an oral health device 104 to remove plaque.

[0103] In some embodiments, the operation 310 includes comparing the efficacy value across different tests to characterize the oral health device 104. For example, multiple motor settings may be tested using the oral health device 104. In a first test, a first motor setting may be selected, and the oral health device 104 may provide a first output affecting a first efficacy media 108, providing a first efficacy value. In a second test, a second motor setting may be selected and the oral health device 104 may provide a second output affecting a second efficacy media 108, providing a second efficacy value. The first efficacy value and the second efficacy 174936-3423-5025\lDocket No. P325815.WO.01 value may be compared to analyze the effect of changing motor settings of the oral health device 104. As can be understood, the method may also be used to test different models or brands of oral health devices, as well as the different motor or operational settings of a particular model or brand of oral health device.

[0104] FIG. 4 is a flow chart of the methods 400. The method 400 is an example embodiment of the operation 308 to generate efficacy media data and the operation 310 to analyze the efficacy media data. In this embodiment, the sensor 112 generates the efficacy media data as a digital image and the processor 120 analyzes the efficacy media data. Although the example method 400 depicts a particular sequence of operations, the sequence may be altered without departing from the scope of the present disclosure. For example, some of the operations depicted may be performed in parallel or in a different sequence that does not materially affect the function of the method 400. In other examples, different components of an example device or system that implements the method 400 may perform functions at substantially the same time or in a specific sequence.

[0105] The method 400 may begin by executing operation 402 to prepare the image for analysis. The operation 402 may include an image uniformity operation. For example, the operation 402 may standardize the image allowing a user to make efficient and accurate analysis across a plurality of images, such as sizing the image so that a selected number of pixels correspond to the dimensions of the efficacy media 108. In some embodiments, the images may be sized using an image cropping software. For example, images uploaded to the processor 120 may be cropped by a user via the user interface 122 so that all images include the same number of pixels. Cropping may also remove portions of the image unsuitable for analysis. For example, if an edge of the efficacy media 108 was damaged, the image of the efficacy media 108 may be cropped so the damaged edge is not analyzed.

[0106] In some embodiments, the operation 402 may include calibrating the image. Images may be calibrated to reduce or remove biased data. For example, during testing, the disturbed layers of the selectively removable layers of the efficacy media 108 may lay over undisturbed areas of the efficacy media 108. The image generated may bias analysis by overestimating the amount of disturbed efficacy media 108, since the disturbed media overlaying the undisturbed media may be detected as disturbed media when analyzed. For example, the efficacy media 108 may include layers of different colors, and a portion of the undisturbed efficacy media 108 may appear as disturbed efficacy media 108 due to the color of the disturbed media overlaying the 184936-3423-502511Docket No. P325815.WO.01 undisturbed layer. The operation 402 may calibrate the image by removing the disturbed media overlaying undisturbed media to reduce overestimation bias. For example, a user may change the color of portions of the image of the efficacy media 108 to remove the overestimation bias described above. In another example, shadows cast on the efficacy media 108 during data capture may underestimate the amount of disturbed media. The image may be calibrated by adjusting the colors of the portions of the image affected by the shadows.

[0107] The method 400 may proceed to operation 404 to convert the image to a binary image. A binary image only contains two colors. For example, an image may be converted to a binary image of only black and white. Converting to a binary image may allow the processor 120 to detect the efficacy value of the image by increasing the contrast between removed and unremoved areas of the efficacy media. The efficacy value may be a range, a ranking, a number, or other types of an identifier. For example, the efficacy value may be the area disturbed by an output of the oral health device 104. In this example, the area disturbed by the oral health device 104 may be colored white and the area undisturbed may be colored black. The operation 404 may convert the image of the efficacy media 108 so that the disturbed area is represented by a black pixel, and the undisturbed area is represented by a white pixel. The processor 120 may then detect the black pixels to determine the amount of area disturbed by the output of the oral health device 104.

[0108] In some embodiments, the operation 402 may occur after converting the image to the binary image in the operation 404. For example, the image may be calibrated after converting the image to a binary image in the operation 404. The image may be calibrated repeatedly as many times as desired. In another example, the binary image may be cropped after converting the image to a binary image in the operation 404. The image may be cropped as many times as desired.

[0109] Once the image has been converted to a binary image, the method 400 may proceed to operation 406 to analyze the binary image. For example, the operation 406 may analyze the binary image on a pixel by pixel basis. In this example, the processor 120 may compute the number of pixels of both binary colors. For example, the processor 120 may compute a number of black pixels and a number of white pixels. The number of black pixels may correspond to the amount of the efficacy media 108 disturbed by the oral health device 104. Since the pixels correspond to an area of the efficacy media 108, the processor 120 may accurately analyze the194936-3423-5025\lDocket No. P325815.WO.01 pixels to determine an area of the efficacy media 108 disturbed by the oral health device 104. The disturbed area can be used to characterize the oral health device 104.

[0110] In some embodiments, the following variables may be used to calculate the disturbed area of the efficacy media 108:^4^ = total area analyzedACMR=total area with complete media removal (CMR)ATD= total area disturbedAWM=total area with white mediah = height of total area analyzedPD= percent area disturbed = percent of white pixelsPWM=percent area with white media visible = percent of black pixelsw = width of total area analyzedThe following equations can calculate the disturbed area of the efficacy media 108:ATA— h x w Eq. (1)MR=TD ~ AWMEq. (2)ATDand ACMRmay be used to evaluate the performance of the oral health device 104. If CMR is not observed on the test sample, only ATDmay be calculated and used for evaluating performance.[OHl] In some embodiments, the efficacy media 108 is coupled to a surface of a media support 502. The media support 502 may be manipulated rather than the efficacy media 108204936-3423-502511Docket No. P325815.WO.01 directly, reducing risk of accidentally touching the efficacy media 108. For example, as shown in FIG. 5, the media support 502 may be a glass slide to which the efficacy media 108 is affixed onto. The efficacy media 108 may be coupled using a fastener 504. As shown for example in FIG. 5, tape may be used to fasten the efficacy media 108 to the media support 502. In other examples, the fastener may include, but is not limited to, glue, screws, staples, and / or clamps.

[0112] FIG. 6 - FIG. 8 show an example embodiment of the test assembly, a test assembly 600. In this example, the oral health device 104 is an oral irrigator with a reservoir. The test assembly is similar to the test assembly 102 described above. As shown for example in the FIG.6, the test assembly 600 is different from the test assembly 102 in that the test assembly 600 includes a test fixture 602 that includes a base 604 to provides stability to the test assembly 102 for performing experiments and couples to a stand 606 via a stand fastener 610. The stand 606 provides a vertical structure which may be used to adjust a height of the oral health device 104 during experimentation and couples to a rod 608 via a rod fastener 612. The rod 608 couples to the oral health device 104 via a device fastener 614. A secondary base 618 provides a testing surface and is coupled to the base 604 via at least one of a secondary base fastener 616. A media securement structure 620 is coupled to the secondary base 618 via at least one of a media securement fastener 622 and holds the efficacy media 108 in place during experimentation.

[0113] In some embodiments, the stand 606, the rod 608, the rod fastener 612, and the device fastener 614 allow the position of the oral health device 104 to be adjusted. For example, a height of the oral health device 104 may be changed, or a distance between the oral health device and the efficacy media 108 may be adjusted. As shown for example in FIG. 6, clamps are used as the rod fastener 612 and the device fastener 614 to secure the structures to the oral health device 104 and allow the position of the oral health device 104 to be adjusted as desired. Other types of fasteners are contemplated and may include, but are not limited to vises, clips, ties, screws, bolts, and the like.

[0114] As shown for example in FIG. 6, the test assembly 600 may be configured so that the oral health device 104 does not move during experimentation. For example, the position of the oral health device 104 may be fixed so that the oral health device 104 provides consistent testing environments. In other embodiments, the test assembly 102 is configured to allow the oral health device 104 to move during experimentation. The oral health device 104 may simulate actual use scenarios if configured to move during experimentation. For example, the 214936-3423-5025\lDocket No. P325815.WO.01 configuration of the test assembly 102 may simulate hand movements of users during experimentation. These configurations may include rotating the oral health device 104 and / or moving the oral health device 104 along a plane relative to the efficacy media 108.

[0115] The secondary base may be made of a material selected for its resistance to corrosion and / or force. For example, the secondary base 618 may be made out of metal, a polymer, or ceramic. In some embodiments, the base 604 and the secondary base 618 form a unitary body comprised of the same material. As shown for example in FIG. 6, the secondary base fastener 616 to secure the secondary base 618 to the base 604 may be a clamp. However, other fasteners are contemplated, including but not limited to screws, bolts, studs, vises, tape, etc.

[0116] FIG. 9 shows a data generation assembly 900, an example embodiment of the data generation assembly. A camera on a smart phone is the sensor 112. The efficacy media 108 is coupled to the efficacy media fixture 116 and aligned with the camera using the sensor fixture 114. The efficacy media 108 is held flush against the efficacy media fixture 116 with the weight of the sensor fixture 114, which prevents inconsistencies with the data capture.

[0117] FIG. 10A, FIG. 10B, FIG. 11 A, and FIG. 11B show examples of the efficacy media 108 rejected during operation 302. In the figures, the efficacy media 108 formed a bubble underneath the layers of media, which may have been caused by a weak bond between the middle layer and the bottom layer.

[0118] FIG. 12 shows another example of the efficacy media 108 filtered during operation 302. A large portion of the top layer of the efficacy media 108 peeled off due to the output of the oral health device 104. The peel off may be caused by a weak bond between the top layer and the middle layer of the efficacy media 108.

[0119] FIG. 13 shows an example of the efficacy media 108 after operation 206. The plaque removal abilities of an oral irrigator were tested.

[0120] FIG. 14A - FIG. 15 show examples of utilizing colored backgrounds with the efficacy media 108. The background colors selected include black, red, and white. The black background was used to calculate CMR performance of the oral health device 104. The white background was used for the pixel by pixel analysis. The red background was used to visually compare the different tests.

[0121] Referring to FIG. 16 and FIG. 17 show examples of the efficacy media 108 coupled to the efficacy media fixture 116. The efficacy media fixture 116 defines an aperture that media support 502 may be positioned within. The aperture secures the position of the media support 224936-3423-502511Docket No. P325815.WO.01 502 and allows a user to grab the edges of the media support 502 without touching the efficacy media 108.

[0122] Referring to FIG. 18 - FIG. 20, examples of the efficacy media 108 prepared for data capture are shown. A colored paper is positioned behind and flush against the efficacy media 108. A paper positioned on top of and flush against the efficacy media 108. The area of the efficacy media 108 affected by the oral health device 104 is positioned centrally relative to a 10 mm by 10 mm square aperture included in the paper. The dimensions are used to calculate a total area, which will correspond to a total number of pixels, for example, in the method 400.

[0123] FIG. 21 A and FIG. 21B show an example of an embodiment of the sensor fixture 114 and the sensor 112. The sensor fixture 114 includes a spacer to maintain a distance between the sensor 112 and the efficacy media 108. The sensor 112 is a camera in a smart phone.

[0124] An example of a binary image before and after image cleaning is shown in FIG. 22. Image A shows the binary image before cleaning, and image B shows the binary image after cleaning.

[0125] FIG. 23 is a screenshot of an example software used to clean an image. The software prevents undisturbed media contaminated with disturbed media from affecting the pixel by pixel analysis by re-coloring the contaminated portions. FIG. 24 shows example image A, which depicts the image before cleaning, and example image B, which depicts the image after cleaning.

[0126] FIG. 25 - FIG. 27 show screenshots of examples of cropping images captured from the efficacy media 108 with software. FIG. 28 shows an example of a cropped image reduced to a 327 pixel by 327 pixel square ready for data analysis.

[0127] FIG. 29 and FIG. 30 show example screenshots during operation 404 to convert the image to a binary image. FIG. 31 shows an example of the image from FIG. 29 and FIG. 30 converted into a binary image ready for analysis.

[0128] FIG. 32 and FIG. 33 show example screenshots of operation 404 and operation 406 executed with different colored backgrounds provided in operation 402. A black background and a white background were used, resulting in different calculated area of disturbed media. The different colored backgrounds provide different insights to the efficacy of the oral health device 104.234936-3423-5025\lDocket No. P325815.WO.01

[0129] The description of certain embodiments included herein is merely exemplary in nature and is in no way intended to limit the scope of the disclosure or its applications or uses. In the included detailed description of embodiments of the present systems and methods, reference is made to the accompanying drawings which form a part hereof, and which are shown by way of illustration specific to embodiments in which the described systems and methods may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice presently disclosed systems and methods, and it is to be understood that other embodiments may be utilized, and that structural and logical changes may be made without departing from the spirit and scope of the disclosure. Moreover, for the purpose of clarity, detailed descriptions of certain features will not be discussed when they would be apparent to those with skill in the art so as not to obscure the description of embodiments of the disclosure. The included detailed description is therefore not to be taken in a limiting sense, and the scope of the disclosure is defined only by the appended claims.

[0130] From the foregoing it will be appreciated that, although specific embodiments of the invention have been described herein for purposes of illustration, various modifications may be made without deviating from the spirit and scope of the invention.

[0131] The particulars shown herein are by way of example and for purposes of illustrative discussion of the preferred embodiments of the present disclosure and are presented in the cause of providing what is believed to be the most useful and readily understood description of the principles and conceptual aspects of various embodiments of the invention. In this regard, no attempt is made to show structural details of the invention in more detail than is necessary for the fundamental understanding of the invention, the description taken with the drawings and / or examples making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

[0132] As used herein and unless otherwise indicated, the terms “a” and “an” are taken to mean “one”, “at least one” or “one or more”. Unless otherwise required by context, singular terms used herein shall include pluralities and plural terms shall include the singular.

[0133] Unless the context clearly requires otherwise, throughout the description and the claims, the words ‘comprise’, ‘comprising’, and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of “including, but not limited to”. Words using the singular or plural number also include the plural and singular number, respectively. Additionally, the words “herein,” “above,” and “below” and 244936-3423-5025\lDocket No. P325815.WO.01 words of similar import, when used in this application, shall refer to this application as a whole and not to any particular portions of the application.

[0134] All relative, directional, and ordinal references (including top, bottom, side, front, rear, first, second, third, and so forth) are given by way of example to aid the reader’s understanding of the examples described herein. They should not be read to be requirements or limitations, particularly as to the position, orientation, or use unless specifically set forth in the claims. Connection references (e.g., attached, coupled, connected, joined, and the like) are to be construed broadly and may include intermediate members between a connection of elements and relative movement between elements. As such, connection references do not necessarily infer that two elements are directly connected and in fixed relation to each other, unless specifically set forth in the claims.

[0135] Of course, it is to be appreciated that any one of the examples, embodiments or processes described herein may be combined with one or more other examples, embodiments and / or processes or be separated and / or performed amongst separate devices or device portions in accordance with the present systems, devices and methods.

[0136] Finally, the above discussion is intended to be merely illustrative of the present system and should not be construed as limiting the appended claims to any particular embodiment or group of embodiments. Thus, while the present system has been described in particular detail with reference to exemplary embodiments, it should also be appreciated that numerous modifications and alternative embodiments may be devised by those having ordinary skill in the art without departing from the broader and intended spirit and scope of the present system as set forth in the claims that follow. Accordingly, the specification and drawings are to be regarded in an illustrative manner and are not intended to limit the scope of the appended claims.254936-3423-502511

Claims

Docket No. P325815.WO.01CLAIMSWhat is claimed is:

1. A method to determine efficacy of an oral health device, the method comprising:impinging an efficacy media with an output of the oral health device; and identifying an efficacy value of the oral health device by analyzing the impinged efficacy media.

2. The method of claim 1, further comprising:configuring a test assembly,wherein the oral health device and the efficacy media are removably coupled to the test assembly, and the test assembly defines a set position between the oral health device and the efficacy media; andpreparing the efficacy media by one or more of drying the efficacy media, or housing the efficacy media in a dark room.

3. A method as in any of the preceding claims, in which the impinged efficacy media has portions removed by the impingement and the portions removed determines the efficacy value.

4. A method as in any of the preceding claims, in which a difference between an area of the efficacy media before impinging and an area of the impinged efficacy media determines the efficacy value.

5. A method as in any of the preceding claims, in which the testing assembly defines a fixed gap from 0.1 mm to 3.0 mm between the oral health device and the efficacy media.

6. A method as in any of the preceding claims, in which the efficacy media includes a substrate and at least one layer of a selectively removable material.

7. A method as in any of the preceding claims, in which the efficacy media includes at least one layer of a colored gel.

8. A method as in any of the preceding claims, in which the method further comprises performing a first pass analysis, wherein the efficacy media affected by one or more of a264936-3423-5025UDocket No. P325815.WO.01 manufacturing error or a testing error is removed from the method and the efficacy value is not identified.

9. A method as in any of the preceding claims, in which the oral health device is an oral irrigator and / or an electric toothbrush.

10. A method to analyze the efficacy of an oral health device based on an efficacy value comprising:receiving a data set of efficacy media impinged by an output of an oral health device; andanalyzing, by a processor, the efficacy value of the dataset of impinged efficacy media.

11. The method of claim 10, further comprising:converting the data set having a plurality of pixels including color variations to a binary dataset of black and white pixels; andanalyzing the converted dataset to determine the efficacy value,wherein the dataset is presented to a user to convert the dataset to the binary dataset via a user interface.

12. A method as in any of claims 10-11, in which the processor determines the efficacy value based on one or more of:a height of the total area analyzed;a width of the total area analyzed;a percent of black pixels of the dataset; anda percent of white pixels of the dataset.

13. A method as in any of claims 10-12, in which the method further comprises enhancing the efficacy media by positioning a background behind the efficacy media.

14. A method as in any of claims 10-13, in which the method further comprises a first pass analysis of the efficacy media to filter the efficacy media including an error.

15. A method as in any of claims 10-14, in which an image sensor generates the data of the efficacy media as an image of the efficacy media.274936-3423-5025\lDocket No. P325815.WO.01 16. The method of claim 14, wherein the processor analyzes the image of the efficacy media on a pixel by pixel basis.

17. A method as in any of claims 15-16, in which the processor converts the image of the efficacy media to a binary image.

18. A system to test the efficacy of an oral health device comprising:a test assembly comprising:a test fixture, wherein the oral health device and an efficacy media are configured to be removably coupled to the test fixture;a data generating assembly comprising:a sensor to generate a data of the efficacy media;an efficacy media fixture, wherein the sensor removably couples to the sensor fixture, and the efficacy media removably couples to the efficacy media fixture; andan analysis assembly comprising:a processor to determine an efficacy value of the oral health device; and a user interface.

19. The system of claim 18, wherein the sensor is an image sensor and the data generated is an image.

20. A system as in any of claims 18 or 19, in which the efficacy media includes a substrate and at least one layer of a selectively removable material.

21. The system of claim 20, wherein the efficacy value is based on difference between a first area of the at least one layer of the selectively removable material and a second area of the selectively removable material.

22. A system as in any of the claims 20 or 21, in which the efficacy value is based on difference between a first height of the at least one layer of selectively removable material and a second height of the at least one layer of selectively removable material.

23. A system as in any of the claims 18-22, in which the efficacy media includes at least one layer of a colored gel.284936-3423-5025\lDocket No. P325815.WO.01 24. A method to determine efficacy of an oral health device, the method comprising:analyzing by a processor a captured image of an efficacy media impinged by a fluid stream ejected by the oral health device;identifying by the processor a removed portion of the efficacy media; and generating by the processor an efficacy indication based on the removed portion.

25. The method of claim 24, wherein identifying the removed portion includes calibrating the captured image to remove a biased data.

26. The method of claim 24, wherein the removed portion is identified by converting the captured image to a binary image by the processor, the binary image including a first portion in a first color, and a second portion in a second color.

27. The method of claim 26, wherein the first color corresponds to the removed portion of the efficacy media.

28. The method of claim 24, wherein the captured image is cropped, by the processor, to a first number of pixels corresponding to an area of the efficacy media.

29. The method of claim 24, wherein the processor determines an area of the efficacy media and an area of the removed portion, and the efficacy indication is based on the area of the removed portion and the area of the efficacy media.

30. The method of claim 29, wherein the area of the efficacy media and the area of the removed portion are determined on a pixel by pixel basis.294936-3423-502511

Images