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K Number
K991948
Device Name
DR. B'S MOUTHPIECE, MODEL 32129-10002
Manufacturer
SNORE - EZZER
Date Cleared
1999-09-02

(85 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 Alleviate or correct simple snoring by maintaining an open airway during sleep and to prevent bruxing and grinding of teeth.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for "Dr. B's Mouthpiece, Model 32129-10002" with the trade name "Snore-Ezzer, LLC". This document states that the device has been found substantially equivalent to a legally marketed predicate device.

However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert qualifications, or multi-reader multi-case studies.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present in the document.
  2. Sample sized used for the test set and the data provenance: This information is not present in the document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present in the document.
  4. Adjudication method for the test set: This information is not present in the document.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size: This information is not present in the document.
  6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: This information is not present in the document.
  7. The type of ground truth used: This information is not present in the document.
  8. The sample size for the training set: This information is not present in the document.
  9. How the ground truth for the training set was established: This information is not present in the document.

The document is a regulatory clearance and details the FDA's decision based on the application, not the technical study results themselves. To find the information you're looking for, you would typically need to refer to the 510(k) Summary or the 510(k) Premarket Notification submission documents, which are separate from this clearance letter.

§ 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.”