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510(k) Data Aggregation

    K Number
    K030016
    Device Name
    TEOAE25
    Manufacturer
    INTERACOUSTICS A/S, ASSENS
    Date Cleared
    2003-03-28

    (85 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    K141524
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TEOAE25 is an accessory to the EP15 or EP25 platform and provides the ability to test the cochlea functions of infants, children and adults in hospitals, nurseries, ENT clinics or audiology offices. It measures the amount of otoacoustic emission (OAE) present in the ear after a stimulus, and it allows a trained operator to get objective information about the cochlea function.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called TEOAE25, an accessory to the EP15 or EP25 platform used to test cochlea functions.

    While the document confirms that the device has been reviewed and found "substantially equivalent" to legally marketed predicate devices, it does not contain the specific information required to complete the table and answer the questions related to acceptance criteria and device performance studies.

    The letter focuses on regulatory approval based on equivalence, not on a detailed breakdown of performance studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methods. Therefore, I cannot extract the requested information from this document.

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