(148 days)
Snore-Aid® Max is prescribed for the patient by the healthcare professional.
A. Snore-Aid® Max is indicated for use in patients with benign snoring, or snoring and mild to moderate obstructive sleep apnea (OSA) where mandibular advancement and tongue positioning can increase pharyngeal air space.
B. Snore-Aid® Max is indicated to prevent symptoms of nocturnal parfunctional jaw activity in patients who are undergoing treatment for snoring and/or OSA by mandibular advancement and tongue positioning.
The Snore-Aid® Max is a hybrid appliance that may utilize the external lip shield or it may utilize an internal lip shield. In the latter case, the lip shield must be applied against a thin vacuum formed tray to protect the gingival tissue and adsorb pressure across the maxillary arch. The value of both methods is that there is no hinge required in the appliance. Also, the design of Snore-Aid® Max facilitates a simple and inexpensive chair side process using polycaprolactone to mold and customize the body of the appliance.
This document is a 510(k) summary for the Snore-Aid® Max device, an anti-snoring device. The document explicitly states "Clinical Data: See section on performance" but no such section detailing performance, acceptance criteria, or a study is included in the provided text.
Therefore,Based on the provided text, there is no information available regarding:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size.
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The document primarily focuses on establishing substantial equivalence to predicate devices (Snore-Aid® Plus, Quiet Knight, and Snore Guard) based on intended use and technological characteristics, rather than presenting clinical study data regarding acceptance criteria and performance. The FDA letter confirms the substantial equivalence determination but does not refer to a detailed performance study within 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.”