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K Number
K132933
Device Name
THE MOSES ELITE APPLIANCE
Manufacturer
ALLEN J. MOSES, DDS, LTD.
Date Cleared
2014-04-25

(219 days)

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

The Moses Elite 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.

Device Description

Not Found

AI/ML Overview

This document is primarily an FDA 510(k) clearance letter for "The Moses™ Elite Appliance". It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria. The letter acknowledges that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication method for a test set.
  5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size.
  6. Whether a standalone performance study was done.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document pertains to regulatory clearance, not the detailed results of a performance study.

§ 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.”