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510(k) Data Aggregation

    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
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    DR. B'S MOUTHPIECE, MODEL 32129-10002

    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.

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