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The Breath Taker is intended to be used for the manual removal of bacteria from the human tongue for the purpose of freshening the breath, enhancing taste and improving oral hygiene. It is used by placing the selected scraping edge on the back of the extended tongue then pulling forward with sufficient pressure to scrape the tongue and remove bacteria. The Breath Taker is intended for over-the-counter use as a personal hygiene tool by men and women of all ages and physical conditions.

The Breath Taker is intended to be used for the manual removal of bacteria from the human tongue for the purpose of freshening the breath, enhancing taste and improving oral hygiene. It is used by placing the selected scraping edge on the back of the extended tongue then pulling forward with sufficient pressure to scrape the tongue and remove bacteria.

I am sorry, but the provided text from the FDA 510(k) approval letter for the "Breath Taker" device does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving those criteria.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was approved based on its substantial equivalence to a predicate device, not necessarily on a de novo study demonstrating performance against specific acceptance criteria. The letter and its enclosure (Indications for Use) focus on the intended use and regulatory classification, not on performance metrics.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance: This information is not present.
2. Sample size used for the test set and data provenance: No test study data is described.
3. Number of experts used to establish ground truth and their qualifications: Not applicable as no specific performance study is detailed.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned.
6. Standalone performance: Not mentioned.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

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