(290 days)
- For the temporary or trial treatment of snoring and mild to moderate obstructive sleep apnea in adults over age 18. The Silent Sleep is not intended to be used for more than 30 days.
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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for an intraoral device called "Silent Sleep." It discusses the regulatory classification and general controls applicable to the device.
However, this document does not contain any information about acceptance criteria for device performance, a study proving device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment methods.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from this document.
§ 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.”