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To remove plaque and food debris from the surface of the tongue.

The Enfresh Tongue Brush and the predicate tongue brushes, tongue scrapers, and tongue cleaners have very similar principles of operation. They are all manual devices that are used by applying a brushing, scraping, or both brushing and scraping motion to the surface of the tongue to remove plaque and food debris from the surface of the tongue. The handle and the bristles of the Enfresh Tongue Brush and Garry Laboratories's The Tongue Brush are composed of plastic, rubber, and nylon, while Telefax International's OOLI-U (Tongue Scraper) is composed of stainless steel.

This document is a 510(k) premarket notification for the Enfresh Tongue Brush, submitted to the FDA in 1997. It declares substantial equivalence to previously cleared devices rather than providing a study proving specific performance acceptance criteria. Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or stated based on the given document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or report performance metrics for the Enfresh Tongue Brush. The basis for clearance is "substantial equivalence" to predicate devices, implying that its performance is presumed to be similar to those already on the market and considered safe and effective.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No specific test set or study data is presented for the Enfresh Tongue Brush. The argument for clearance relies on the long history of safe use of similar devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment is mentioned as no specific study data is presented for the Enfresh Tongue Brush.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set or adjudication method is mentioned.

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 manual tongue brush, not an AI-assisted diagnostic device.

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

Not applicable. This is a manual tongue brush.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No specific ground truth was used for this 510(k) submission, as it relies on substantial equivalence to predicate devices with a long history of safe use.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an algorithm.

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

Not applicable. This device does not involve a training set for an algorithm.

Summary of the document's argument for acceptance:

The Enfresh Tongue Brush was cleared based on its substantial equivalence to existing predicate devices (Garry Laboratories's The Tongue Brush and Telefax International's OOLI-U (Tongue Scraper)). The argument for substantial equivalence is based on:

• Identical Intended Use: To remove plaque and food debris from the surface of the tongue.
• Very Similar Principles of Operation: Manual devices using brushing, scraping, or both motions.
• Very Similar Technological Characteristics: Composed of common, biocompatible materials (plastic, rubber, nylon, or stainless steel) with a long history of safe use in medical devices.

The document explicitly states: "The safety and effectiveness of the Enfresh Tongue Brush is based on the long history of safe use of tongue brushes, tongue scrapers, tongue cleaners, as well as the safe use of manual toothbrushes. ... Thus, the Enfresh Tongue Brush is substantially equivalent to the predicate devices, because the Enfresh Tongue Brush raises no new issues of safety or effectiveness."

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