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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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