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510(k) Data Aggregation

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

    SNORE-EZZER

    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.

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