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K Number
K974531
Device Name
SNORE-EZZER
Manufacturer
SNORE - EZZER
Date Cleared
1998-02-12

(72 days)

Product Code
LRK
Regulation Number
872.5570
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

To reduce or alleviate snoring by maintaining an open airway during sleep.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for a device called "Snore-Ezzer." It confirms that the device is substantially equivalent to a pre-amendments device and can be marketed.

While it mentions the "Indication For Use" (to reduce or alleviate snoring by maintaining an open airway during sleep), it does not provide:

  • A table of acceptance criteria and reported device performance.
  • Details about the sample size, data provenance, number of experts, adjudication method, or ground truth for any test set.
  • Information about MRMC studies, standalone algorithm performance, or training set details.

The letter is a regulatory approval document, not a scientific study report or a summary of validation testing. It indicates that the device has met the regulatory requirements for market clearance based on a determination of substantial equivalence, but it does not disclose the specific performance metrics or studies used to demonstrate that functional equivalence.

§ 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.”