(103 days)
The AVEOtsd (Tongue Stabilizing Device) Mouthpiece is intended as an aid in the reduction of snoring for adults at least 18 years old.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "The AVEOtsd (Tongue Stabilizing Device) Mouthpiece." It states that the device is substantially equivalent to a predicate device for its intended use as an aid in the reduction of snoring for adults.
However, this document does not contain any information about acceptance criteria, device performance testing, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types and establishment methods.
The letter is a regulatory approval document confirming market clearance, not a technical report detailing the device's performance study. Therefore, I cannot answer the questions posed in the prompt based on the provided 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.”