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510(k) Data Aggregation

    K Number
    K983435
    Device Name
    ROTORBLADE
    Manufacturer
    LI MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    1999-04-29

    (212 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Abbreviated
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K950272
    Why did this record match?
    Reference Devices :

    K950272

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Shoulder - rotator cuff repair

    Device Description

    Made from surgical grade PLL (homopolymer poly (L(-)-lactide), the LM Anchor is designed as a propeller blade type anchor device through which suture is passed to provide a means for soft tissue to bone attachment.

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device (Li Medical RotorBlade™) and an FDA clearance letter. It does not contain information about an AI/ML powered device, nor does it detail acceptance criteria and a study to prove the device meets these criteria in the context of an AI/ML algorithm.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided text.

    The "Performance Data" section merely states: "Pre-clinical testing in cadaver specimen showed that the mean pullout strength of the LM Anchor was substantially equivalent to the mean pullout strength of the Mitek anchors." This is a general statement of equivalence for the physical device, not an AI/ML performance metric.

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