(362 days)
For the treatment of snoring and mild to moderate obstructive sleep apnea.
Not Found
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.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”