(90 days)
The Adjustable TheraSnore is a treatment for snoring
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Adjustable Therasnore." This document approves the device for marketing and mentions its indications for use (treatment for snoring).
However, the document does not contain any information regarding acceptance criteria, a study proving device performance, sample sizes, data provenance, expert qualifications, or any other details about performance evaluations. It is solely a regulatory approval document.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them 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.”