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For the treatment of snoring and mild to moderate obstructive sleep apnea.

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The provided text is a 510(k) premarket notification approval letter for the SnoreHook Discluder. It confirms that the device is substantially equivalent to legally marketed predicate devices for the treatment of snoring and mild to moderate obstructive sleep apnea.

However, the letter does not contain any information regarding acceptance criteria, specific device performance data, study details (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), or any comparative effectiveness studies (MRMC or standalone).

Therefore, I cannot provide the requested information from the given text.

The document essentially states that the FDA has reviewed the submission and determined that the device is substantially equivalent to existing devices, allowing it to be marketed. It does not detail the technical studies or precise performance metrics used to make that determination.

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