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To reduce or alleviate night time snoring and mild to moderate obstructive sleep apnea (OSA).

The TAP III Anti-Snoring device is comprised of:

• Lower tray fitted over the lower teeth.
• Upper tray fitted over the upper teeth.
• Impression material
• Hook and Base mechanism to attach lower tray to upper tray.

The provided text is a summary of safety and effectiveness for a medical device (TAP III), not a study. It compares the TAP III to predicate devices but does not describe acceptance criteria for studies or report device performance against such criteria in the way a clinical study would. The document states "Non applicable under Section 514" for "Performance Testing," indicating that a new performance study was not required for this 510(k) submission.

Therefore, the following information cannot be extracted from the provided text:

• Acceptance criteria and reported device performance (as these relate to a study's outcomes)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and their qualifications
• Adjudication method
• Multi-reader multi-case (MRMC) comparative effectiveness study details
• Standalone performance details
• Type of ground truth used
• Sample size for the training set
• How ground truth for the training set was established

The only performance-related information mentioned is a "Reduced AHI in patients" of "72%" for the TAP III, which is also listed for all predicate devices. This appears to be a characteristic of the device type rather than a specific result from a study conducted on the TAP III itself for this submission. The document explicitly states "Non applicable under Section 514" for Performance Testing, suggesting that the substantial equivalence of the TAP III to existing devices means a new performance study was not deemed necessary by the FDA for this particular submission.

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