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510(k) Data Aggregation

    K Number
    K051487
    Device Name
    DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE
    Manufacturer
    DOCTOR'S RESEARCH GROUP, INC.
    Date Cleared
    2005-12-22

    (199 days)

    Product Code
    KHJ
    Regulation Number
    874.3620
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The DRG Laryngeal Augmentation Implant Device is indicated for use in moreations for other inn for treatment of patients with unilateral vocal cord paralysis.

    Device Description

    Laryngeal Augmentation Implant

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information about the acceptance criteria, a study proving device performance, sample sizes, ground truth establishment, or any details related to AI/MRMC studies for the Laryngeal Augmentation Implant.

    The document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It specifies the regulation number, product code, and indications for use. However, it does not include the detailed study information typically found in a clinical trial report or a summary of safety and effectiveness.

    Therefore, I cannot provide the requested table or answer the specific questions about the study design, sample sizes, expert qualifications, or ground truth without further information.

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