(150 days)
The SLEEPAPPADV is intended for the management of snoring and mild to moderate obstructive sleep apnea in adults 18 years of age and older.
Not Found
This FDA letter for K182202, a 510(k) premarket notification for the SLEEPAPPADV™ device, does not contain information regarding detailed acceptance criteria, specific study designs, or performance metrics. It primarily confirms the device's substantial equivalence to a predicate device and outlines general regulatory obligations.
Therefore, I cannot provide the requested information, including the table of acceptance criteria and device performance, sample sizes, data provenance, expert details, adjudication methods, MRMC study results, standalone performance, ground truth types, or training set details. This information is typically found in the 510(k) summary or the full submission, which is not provided in the given text.
§ 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.”