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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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