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K Number
K032410
Device Name
SNORENTI
Manufacturer
JAMES P BOYD
Date Cleared
2005-02-28

(574 days)

Product Code
LQZ
Regulation Number
872.5570
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. Quiet Night This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
  2. Quiet Night MA This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea. This appliance is intended for use when the Quiet Night is ineffective.
Device Description

Not Found

AI/ML Overview

I am sorry, but based on the text provided, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA, indicating that the device "Quiet Night Sleep Appliance" and "Quiet Night MA Sleep Appliance" has been found substantially equivalent to legally marketed predicate devices.

The letter mentions:

  • Trade/Device Name: Quiet Night Sleep Appliance, Quiet Night MA Sleep Appliance
  • Regulation Number: 872.5570
  • Regulation Name: Intraoral Devices for Snoring Intraoral Devices for Snoring and Obstructive Sleep Apnea
  • Regulatory Class: IIProductName: LQZ
  • Indications For Use:
    • Quiet Night: Treatment of mild to moderate obstructive sleep apnea.
    • Quiet Night MA: Treatment of mild to moderate obstructive sleep apnea, intended for use when the Quiet Night is ineffective.

However, the document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size or data provenance for any test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication method.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or effect size.
  6. If a standalone performance study was done.
  7. The type of ground truth used.
  8. Sample size for the training set.
  9. How the ground truth for the training set was established.

This kind of detailed performance data is typically found in the 510(k) submission itself, which is not fully included in this document. The provided text is the FDA's decision letter, not the full submission or a detailed study report.

§ 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.”