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The Oral-B® iO Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene.

The Oral-B® iO Test Drive Power Brush Trial Program Kit is indicated for use under the direct supervision of a dental professional, exclusively at conventions (e.g. professional, scientific, trade shows), as part of the Oral-B® iO Test Drive Power Brush Trial Program.

The Oral-B® iO Test Drive Power Brush Trial Program for conventions (e.g. professional, scientific, trade shows), is designed to introduce convention delegates to the newest, most advanced Oral-B electric rechargeable toothbrush as a means to promote good oral hygiene. The program kit contains a power toothbrush consisting of a rechargeable handle, a charger, replacement brush heads, and instructions for the proper use and care of the device. The program kit also contains plastic dental sheaths to prevent soiling and therefore allowing for easier cleaning of the multi-user handle. The sheath is manufactured by TIDI Products, LLC, is provided to Procter & Gamble as a finished, packaged non-sterile device (K132953) for inclusion in the program kit as an accessory. Detailed instructions for cleaning and disinfection of the reusable handle are also included. The program kit is indicated for use as an introductory trial, exclusively within the confines of a convention (e.g. professional, scientific, trade shows), under the direct supervision of a dental professional as part of the Oral-B® iO Test Drive Power Brush Trial Program.

The provided text is a 510(k) Premarket Notification from the U.S. Food and Drug Administration (FDA) regarding a powered toothbrush. It concerns the "Oral-B iO Test Drive Power Brush Trial Program Kit" (K200881). The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Oral-B Test Drive Power Brush Trial Program Kit, K141018) and a reference device (Oral-B iO Rechargeable Power Toothbrush, a Class I, 510(k) exempt device).

The information provided does not relate to an AI/ML medical device, a multi-reader multi-case (MRMC) comparative effectiveness study, or the use of AI assistance for human readers. It lists performance data for a physical device, including biocompatibility, electrical safety, software verification, and cleaning/disinfection validation. Therefore, many of the requested categories related to AI/ML device performance and study design (e.g., sample size for test/training sets for AI, expert adjudication, ground truth definition for AI, effect size of AI assistance) are not applicable to this document.

However, I can extract the relevant acceptance criteria and how the device meets them based on the provided "PERFORMANCE DATA" section.

Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (a powered toothbrush) and not an AI/ML algorithm, the "acceptance criteria" are typically defined by compliance with recognized standards and successful completion of specific non-clinical and performance tests to demonstrate safety and effectiveness for its intended use, and ultimately substantial equivalence to a predicate device. The performance data section describes how the device meets these requirements.

Here's a table summarizing the "acceptance criteria" (or performance areas tested for compliance) and the reported device performance:

Since this is not an AI/ML device, the following points are largely not applicable or cannot be definitively answered from the provided text:

2. Sample sizes used for the test set and the data provenance:

   • For biocompatibility, electrical safety, EMC, and software, "samples" are devices or components. Specific numbers of units tested are not provided in this summary, but these are typically engineering and lab tests, not clinical studies with human subjects for efficacy.
   • For Cleaning and Disinfection Validation, the document mentions testing under "simulated normal use and worst-case scenario for wear" and establishing a "reuse life of 240 uses." This number (240 cycles) could be considered a "sample size" for this specific durability test.
   • For Human Factors Usability testing, "several formative and a summative" studies were performed. The number of participants in these studies (i.e., "sample size") is not specified.
   • Data Provenance: The manufacturer is Procter & Gamble Manufacturing GmbH (Marktheidenfeld, Germany) and distributed in the U.S.A. by Procter & Gamble, Co. (Cincinnati, Ohio). The studies are non-clinical, not patient data (retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML (e.g., highly accurate disease labels) is not relevant for this type of device submission. The "ground truth" here is compliance with engineering standards and predefined performance specifications. Expert validation is implicitly part of these standardized testing processes (e.g., certified labs, qualified engineers).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is typically related to expert review of medical images or patient data for ground truth establishment in AI/ML studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical powered toothbrush, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is a software component (Level of Concern - Moderate), but it's part of the device's function (e.g., user interface, power management, potentially guidance for cleaning), not a standalone diagnostic algorithm. The software verification confirms it "performs as intended."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's performance is derived from:

   • Compliance with recognized standards: ISO 10993 (biocompatibility), UL 1431, IEC 60335 series, ISO 20127 (electrical safety), 47 CFR Parts 15B, 15C, 18 (EMC).
   • Successful completion of pre-defined non-clinical tests: Cleaning/disinfection validation (e.g., microbial reduction, material integrity), Human Factors Usability (user ability to follow instructions).
   • Performance against specifications: e.g., reuse life, satisfactory cleaning/disinfection.

8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning.

9. How the ground truth for the training set was established: Not applicable for the same reason as above.

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The Oral-B® Test Drive Power Brush Trial Program Kit is intended for use as a power toothbrush to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis.

The Oral-B® Test Drive Power Brush Trial Program Kit is indicated for use under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

The Oral-B® Test Drive Power Brush Trial Program is designed to introduce potential users to a power toothbrush as a means to promote good oral hygiene, including the reduction of dental plaque and the treatment and prevention of gingivitis. The program kit that is used in the trial program contains a power toothbrush consisting of a rechargeable handle, charger, replacement brush heads, and instructions for the proper use and care of the device. Additionally, the program kit contains plastic dental sheaths to prevent soiling of the multi-user handle and instructions for cleaning and disinfection of the reusable handle. The program kit is indicated for use as an introductory trial to a power toothbrush under the supervision of a dental professional as part of the Oral-B® Test Drive Power Brush Trial Program.

This document is a 510(k) premarket notification for a Class I powered toothbrush. It asserts substantial equivalence to a predicate device and does not involve AI or complex diagnostic criteria. Therefore, most of the requested information regarding acceptance criteria, study details, expert involvement, and AI performance metrics are not applicable to this type of device and submission.

Here's an breakdown of the relevant information provided and why other categories are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the sense of specific numerical performance metrics for a diagnostic or AI device. For a Class I powered toothbrush, substantial equivalence is primarily based on comparing the new device's intended use, design, dimensions, materials, biocompatibility, and general performance to a legally marketed predicate device.

The document states:

• Acceptance Criteria (Implied): The Oral-B® Test Drive Power Brush Trial Program Kit must perform comparably to the predicate device (Oral-B® Rechargeable Toothbrush, K061199) and demonstrate the ability to withstand multiple uses and disinfection without compromising integrity or performance.
• Reported Device Performance:
  • "Benchtop testing for the program kit was performed under conditions that simulated normal use and worst case scenario for wear. The performance testing demonstrated that the program kit handle can sustain multiple fittings of the brush head onto the reusable handle, and that the integrity of the seal remains intact with normal use."
  • "Benchtop testing also demonstrates that the cleaning and disinfection procedure results in satisfactory disinfection of the handle, and that the repeated exposure of the handle to the disinfectant had no effect on the physical characteristics or performance of the device."

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not explicitly stated numerically. The benchtop testing was conducted on an unspecified number of "program kit handles" and "brush heads" to simulate normal use and worst-case scenarios.
• Data Provenance: The testing was "benchtop testing," implying internal lab testing conducted by the manufacturer, Procter & Gamble. No country of origin for test data is specified beyond the manufacturer's location. The testing is prospective in the sense that it was conducted on the device prior to submission, rather than analyzing pre-existing patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not an AI/diagnostic device that requires expert-established ground truth for performance evaluation. The "ground truth" here is adherence to manufacturing specifications and functional performance.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is detailed as this is not a diagnostic device requiring interpretation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This is not an AI-assisted diagnostic device, so MRMC studies are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm or AI component in this device.

7. The type of ground truth used

For this device, the "ground truth" effectively refers to:

• Functional Performance: The ability of the handle to sustain multiple brush head fittings and maintain seal integrity.
• Disinfection Efficacy: The cleaning and disinfection procedure achieving "satisfactory disinfection."
• Material Compatibility: The handle's physical characteristics and performance remaining unaffected by repeated exposure to disinfectant.
  These are established through engineering and microbiology testing in a lab setting.

8. The sample size for the training set

Not applicable. There is no AI or machine learning component requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

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To promote good oral hygiene, including plaque removal and treating and preventing gingivitis.

Oral-B® Sonic Complete™ is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power handle. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® Sonic Complete™ electric toothbrush has a vibrating brush head that moves with a side-to-side movement. The brush head is designed to facilitate deeper penetration of interdental areas. The brush head moves side along the axis of the brush head at 260 Hz at an unloaded angle of ± 5 degrees. The brush head has no moving parts and is similar to a manual brush. The Oral-B® Sonic Complete™ has a longitudinal brush head with a length of 22 mm and a width of a 9mm. The tufts are angled in 3 directions. The inner row with oval tufts and the outer rows are angled in opposite directions at an angle of 7.5 degrees. In addition, the outer rows are angled outwards for improved gumline cleaning at an angle of 5 degrees. The bristles are standard nylon filaments with a diameter of 6 and 6.5 mil. Two rows of bristles are longer and form a power tip for improved interproximal cleaning. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2. The bristle material is Polyamid or PA6.12. The Oral-B® Sonic Complete™ features a Pressure Control to help avoid possible gingival damage by users who apply excessive pressure during brushing; the drive system and the soft bristles are designed so that the bristle tip movement dramatically decreases to almost zero at applied loads above 2 N. It also features a Professional Timer and a Push-Push switch. The Professional Timer automatically interrupts the brushing motion briefly with a short stuttering sound every 30 seconds to remind the user to move to another quadrant of the mouth, so that each quadrant is brushed equally. At the moment we only have a "stuttering timer" as described, however there soon will be a version sounding a "beeping noise" after 2 minutes brushing time, Oral-B® Sonic Complete™ offers customized brushing modes for complete mouth care. The basic godel offers two modes and the deluxe model offers three modes controlled by the Push switch: Clears for a complete cleaning of your teeth and gums, Soft: for the gentle care of your tongue and other sensitive areas, and Massage: (deluxe model only) for a gentle stimulation of gums. The toothbrush features a round handle, with anti-slip characteristics for better control in wet conditions.

The provided text describes the Oral-B® Sonic Complete™ rechargeable electric toothbrush. While it states that the device has been tested in numerous controlled clinical studies and that these trials evaluated oral soft and hard tissue for safety, plaque, gingivitis, and bleeding, it does not explicitly detail specific quantitative acceptance criteria or the full study methodology in the typical format for medical device performance studies. The document focuses on demonstrating substantial equivalence for an expanded indication for use (treating and preventing gingivitis) rather than presenting a detailed performance study with predefined acceptance criteria for the device itself.

However, based on the information provided, we can infer some aspects related to the testing and "acceptance" of the device in the context of its 510(k) submission.

Here's an attempt to structure the information based on the typical requirements, acknowledging the limitations of the provided text:

Acceptance Criteria and Device Performance

The document does not provide a table with quantitative acceptance criteria for device performance. Instead, the acceptance is based on demonstrating the device's safety and effectiveness for its intended use, particularly the expanded indication of "treating and preventing gingivitis," and its substantial equivalence to predicate devices. The "reported device performance" is descriptive rather than quantitative in the provided text excerpts.

Study Details

The document states that "Oral-B® Sonic Complete™ powered toothbrush has been tested in numerous controlled clinical studies. These trials evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding. Collectively, these studies demonstrate that the Oral-B® Sonic Complete™ powered toothbrush is effective at treating and preventing gingivitis." However, it does not provide all the granular details requested for a single, comprehensive study. It references two clinical studies in the bibliography.

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not explicitly stated in the summary.
   • Data provenance:
     • Study 1 reference (Cronin et al., 2004): Conducted by "New Institutional Service Co., Inc., Dental Research and Product Testing, Northfield, New Jersey, USA." This suggests the data is prospective and from the USA.
     • Study 2 reference (Rosema et al., 2004): Department of Periodontology, Academic Centre for Dentistry Amsterdam. This suggests the data is prospective and from Amsterdam (Netherlands).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated in the provided text. Clinical studies of this nature would typically involve trained dental professionals (e.g., periodontists, dental hygienists) for assessments.

3. Adjudication method for the test set: Not explicitly stated. For clinical studies evaluating gingivitis and plaque, assessments are typically performed by trained examiners following standardized protocols, and reliability checks (e.g., inter-rater agreement) are common, but specific adjudication methods like "2+1" are not mentioned.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

   • The provided text refers to "controlled clinical studies" demonstrating effectiveness, but it does not describe an MRMC study comparing human readers with and without AI assistance. This type of study (MRMC for AI) is typically for diagnostic imaging devices, not direct-to-consumer toothbrushes.
   • The studies mentioned compare the device itself (with its cleaning mechanism) against either a control or another toothbrush, not human readers and AI.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No, this device is a physical toothbrush, not an algorithm. Therefore, "standalone" algorithm performance is not applicable. The device's performance is inherently "human-in-the-loop" as a user operates it.

6. The type of ground truth used:

   • Clinical Endpoints: Based on the description ("evaluated oral soft and hard tissue for safety, plaque, gingivitis and bleeding"), the ground truth would be based on clinical assessments/measurements (e.g., Gingival Index, Plaque Index, Bleeding on Probing) performed by trained dental professionals.
   • Bibliography references studies that focus on "efficacy of two toothbrushes" (Study 1) and "Healing Effect of Experimental Gingivitis Using 2 Sonic Toothbrushes" (Study 2), further indicating clinical measures as ground truth.

7. The sample size for the training set: Not applicable in the context of this device and the provided documentation. This information is relevant for AI/machine learning models which are not described here. The "training set" for a physical device would refer to data used during its development and optimization, which is not detailed in a 510(k) summary for a toothbrush.

8. How the ground truth for the training set was established: Not applicable, as explained above.

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To promote good oral hygiene, including plaque removal and treating and preventing gingivitis.

Oral-B® ProfessionalCare/Oral-B® AdvancePower is a rechargeable electric toothbrush comprised of a charging unit and a rechargeable power unit. The rechargeable power unit is inductively charged and therefore electrically safe in accordance with the Second Edition of the standard for Personal Hygiene and Health Care appliances, UL 1431. The Oral-B® ProfessionalCare/Oral-B® AdvancePower electric toothbrush has an oscillating/rotating technology, a small round brush head that aids tooth-to-tooth cleaning. The brush head is designed to facilitate deeper penetration of interdental areas. The action of the brush head has an oscillation range frequency between 63 to 73 Hz with a vibration frequency of 340 Hz (3800 strokes per minute) and an oscillating range angle of 42° to 60° depending on the toothbrush model.

The brush head design is a small circular brush head and features an arrangement of flagged bristles and power tips. The power tips have tufts of longer bristles on either side of the brush head in the outer ring. These power tips have a wear indicator function and are colored with the FDA approved colorant FD&C blue No.2.

The flagged bristle tufts have tetralocular filaments and are designed to increase the brushing action on tooth surfaces. The bristle material is Polyamid or PA6.12. The toothbrush features a round handle with anti-slip characteristics for better control in wet conditions and offers a variable range of speeds to best meet individual needs.

Oral-B® Professional Care™ Series/Oral-B® AdvancePower™ Series products are rechargeable battery operated toothbrushes. The toothbrush handles are inductively charged so there is no electrical connection between the charger and handle. All electrical components are housed within thermoplastic enclosures and the product is provided with a Listed 1flexible supply cord terminating in a parallel blade attachment plug for connection to a nominal 100-120 V, 50-60 Hz supply source.

The provided text describes a 510(k) summary for the Oral-B® ProfessionalCare™ Series/Oral-B® AdvancePower™ Series powered toothbrush. The submission focuses on the expanded indication for use: "treating and preventing gingivitis," as the device is otherwise 510(k) exempt.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria": The document doesn't explicitly state quantitative acceptance criteria (e.g., "gingivitis must be reduced by X%"). Instead, it lists the general clinical outcomes for which the device was evaluated, and then concludes broad effectiveness and safety based on those evaluations.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document refers to "numerous controlled clinical studies" (page 2) and lists eight bibliography entries for these studies. To determine the exact sample sizes, one would need to consult the referenced individual studies (e.g., Cronin et al. 1998, Haffajee et al. 2001, etc.).
• Data Provenance: Not explicitly stated. The bibliography titles suggest the studies are clinical investigations, likely prospective, evaluating the toothbrush's performance in human subjects. The affiliations of the researchers would likely indicate the countries where the studies were conducted (e.g., "Am J Dent" suggests American journals).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the summary. Clinical studies on oral hygiene typically involve dentists, periodontists, and dental hygienists as examiners to assess clinical parameters (e.g., gingival index, plaque index, bleeding on probing). The document does not specify the number or qualifications of experts involved in the reported studies.

4. Adjudication Method for the Test Set

This information is not provided in the summary. Clinical studies often employ blinding and standardized assessment protocols to minimize bias, but specific adjudication methods (like 2+1 review for discrepancies) are not detailed here.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a powered toothbrush, not an AI-powered diagnostic imaging tool. Therefore, there is no concept of "human readers" or "AI assistance" in the context described. The studies cited compare the powered toothbrush to manual toothbrushes or other powered toothbrushes, assessing clinical outcomes, not diagnostic accuracy.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This section is not applicable. As mentioned above, this is a physical medical device (powered toothbrush), not an algorithm or AI. Its performance is directly tied to its use by an individual.

7. The Type of Ground Truth Used

For the clinical studies referenced, the "ground truth" would be the clinical assessments of oral health parameters by trained professionals. This includes:

• Measurement of plaque accumulation (e.g., using a plaque index).
• Assessment of gingivitis severity (e.g., using a gingival index).
• Measurement of bleeding on probing.
• Evaluation of oral soft and hard tissue for safety (e.g., presence of abrasions, lesions).

These are direct clinical observations and measurements, often considered the gold standard for evaluating oral hygiene devices.

8. The Sample Size for the Training Set

This information is not provided. The concept of a "training set" is typically associated with machine learning or AI models. For a conventional physical device like a toothbrush, clinical studies are conducted to test its performance, not to "train" it.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" in the context of this device. The clinical studies establish the effectiveness and safety for the intended use.

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For promotion of good oral hygiene, including the reduction of dental plaque and gingivitis.

Sonicare® Advance Model 4900 consists of three primary parts: brush head, power handle, and charger base. Central to the brush head are the resonator arm and the torsion bar. The brush head's bristles are mounted in a bristle plate on one end of the arm, two magnets are mounted on the other, and the torsion bar is perpendicular in the middle. A 261-Hz oscillating magnetic flux generated inside the power handle forces the magnets into motion, which then causes the resonator arm to oscillate about the torsion bar. The torsion bar, magnets and bristle plate have a resonant frequency close to the 261-Hz driving frequency, and this enables the system to produce a desired amplitude effect. The bristles vibrate in the direction perpendicular to the bristles' length and nominally perpendicular to the brush's axis.

The oscillating magnetic flux is generated by a stator coil in the power handle, in close proximity to the attachment of the brush head. The flux is controlled by solid-state electronics and powered from two nickel-cadmium rechargeable batteries elsewhere within the handle. Energy for recharging the batteries is transferred from the charger base through a system of induction coils within the power handle and the charger base. Maximum power dissipation by the handle is 3 W.

The charger base runs on standard North American 120 V, 60 Hz power. Internal electronics convert the input power to a 65 kHz output signal for more efficient transfer of power to the handle.

The provided text does not contain specific acceptance criteria in a quantitative or tabular format for the Sonicare® Advance Toothbrush (Model 4900). Instead, the submission relies on demonstrating substantial equivalence to predicate devices through clinical trials.

Below is a summary of the information available regarding the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify quantitative acceptance criteria. Instead, it states that "the studies demonstrate that the Sonicare® Advance toothbrushes reduce gingivitis." This implies that the acceptance criteria were met if the clinical trials showed a statistically significant reduction in gingivitis and no evidence of injury to soft tissues.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document only mentions "a total of seven clinical trials (six controlled)."
• Data Provenance: Not explicitly stated, but clinical trials typically involve human subjects. The fact that the device is marketed in North America (charger base runs on standard North American 120 V, 60 Hz power) might suggest studies were conducted in relevant regions, but this is an inference. The studies are prospective in nature as they are clinical trials evaluating device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The clinical trials would have involved dental professionals, but their specific number, roles in establishing "ground truth," or qualifications are not detailed in this 510(k) summary. Given the endpoints (gingival inflammation, pocket probing depth, clinical attachment level, soft tissue injury), the experts would likely be dentists, periodontists, or dental hygienists.

4. Adjudication method for the test set:

This information is not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is irrelevant; the device is a toothbrush, not an AI-powered diagnostic tool requiring human reader involvement or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is irrelevant; the device is a toothbrush, not an algorithm. Performance is assessed through its physical interaction and biological effect on users.

7. The type of ground truth used:

For the clinical trials, the "ground truth" would have been established through:

• Clinical Examination/Indices: Measurement of gingival inflammation (e.g., using gingival indices), pocket probing depth, and clinical attachment level by trained dental professionals.
• Visual Assessment: Examination of soft tissues for evidence of injury.

8. The sample size for the training set:

This is irrelevant; the device is a physical toothbrush, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This is irrelevant; the device is a physical toothbrush, not a machine learning model.

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But er's Antibacterial Power Toothbrushes are devices that include a handle to be held in the hand and bris les (filaments) at one end to remove adherent plaque and food debris from the teeth to reduce too h decay. The antibacterial agent impregnated in the filament kills bacteria and prevents their growth on : nd between the bristles between uses.

The nylon bristles of the Butler GUM® Vati-Clean™ Toothbrush are impregnated with silver, which provides long-lasting antibacterial protection of the bristles.

The provided document is a 510(k) premarket notification for a medical device, specifically a powered toothbrush. It concerns the substantial equivalence determination for the "Butler GUM® Vari-Clean™ Power Toothbrush."

The document does not contain acceptance criteria or detailed study information typically found in performance studies for medical devices. The primary purpose of this 510(k) submission is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device, not to present novel performance data against specific acceptance criteria.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

• No Acceptance Criteria: The document does not define any specific performance metrics or thresholds for the Butler GUM® Vari-Clean™ Power Toothbrush that would be considered "acceptance criteria."
• No Performance Study: There is no description of a study conducted to demonstrate the device meets any performance criteria. The submission relies on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use.
• No Data on Test Sets, Experts, Adjudication, MRMC, or Ground Truth: Since no performance study is described, there is no information regarding sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, or the type of ground truth used.
• No Information on Training Set: Similarly, for devices relying on demonstrating substantial equivalence, information about training sets for algorithms is not typically present as the device's function is not based on a machine learning model that requires training.

The document mainly focuses on:

• Identifying the applicant and device.
• Describing the device's technological characteristics (nylon bristles impregnated with silver for antibacterial protection).
• Stating its intended use (over-the-counter toothbrush, with antibacterial agent on bristles).
• Identifying a predicate device (Medoral Hygienic Toothbrush, K020776) and arguing for substantial equivalence based on identical bristles.
• The FDA's decision letter confirming substantial equivalence.

In summary, the provided text does not contain the information required to answer your request about acceptance criteria and performance studies. This type of information is typically found in clinical trial reports or detailed performance validation studies, which are not present in this 510(k) summary.

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• Operates at over 30,000 strokes per minute to help remove plaque bacteria ●
• Sonic waves penetrate beyond the bristle tips, for superior cleaning. .
• Ergonomic design with rubberized Comfort-Grip surface. .
• Two-minute timer helps ensure dentist recommended brush time. .

This 2.4 volt rechargeable battery operated toothbrush is a sonic wave plaque remover with rapidly vibrating bristles that penetrate the most difficult-to-clean areas of your mouth - Places your standard toothbrush might miss. It's also gentle, with seven speeds you can adjust to your own sensitivity level. This effective combination of ergonomics and technology brings you an easy, everyday way to prevent tooth decay and gum disease.

The provided text describes a 510(k) summary statement for a sonic toothbrush, the SonicWave™ Sonic Plaque Remover. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. Instead, it focuses on the device's description, intended use, and a claim of substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for the tables and study details based on the provided input. The document is a regulatory submission, not a research study report.

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