(174 days)
The Apinator appliance is intended for use on adult patients 18 years of age and older as an aid for the reduction and /or alleviation of snoring and mild to moderate obstructive sleep apnea.
Not Found
This document is a 510(k) clearance letter for the Apinator™ device and does not contain detailed information about acceptance criteria or specific study results to prove meeting those criteria. The letter primarily confirms that the FDA has reviewed the premarket notification and determined the device to be substantially equivalent to legally marketed predicate devices, based on its intended use as an aid for the reduction and/or alleviation of snoring and mild to moderate obstructive sleep apnea in adults 18 years and older.
Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC study details, or standalone performance) from this particular document. This type of information is typically found in the 510(k) submission itself, including summary reports or clinical study sections, which are not provided here.
§ 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.”