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    K Number
    K982575
    Device Name
    MESH, SURGICAL, POLYMERIC
    Manufacturer
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Cleared
    1998-11-06

    (105 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K922916,K905655
    Why did this record match?
    Device Name :

    MESH, SURGICAL, POLYMERIC

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

    The Surgipro* Mesh Plug** device is indicated for the repair of groin hernia defects.

    Device Description

    Surgipro* Mesh Plug** device is a nonabsorbable, inert sterile, porous, surgical mesh knitted from yarns o polypropylene polymer from which Surgipro* surgical sutures are manufactured.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device (Surgipro™ Mesh Plug) and a letter from the FDA. It does not contain any information about a study proving the device meets acceptance criteria, nor does it mention any performance metrics, sample sizes, expert involvement, or any of the other specific details requested in the prompt for AI/algorithm performance.

    This document is a regulatory submission for a physical medical device (surgical mesh), not an AI/algorithm-based device. Therefore, a study proving the device meets acceptance criteria in the context of AI (e.g., accuracy, sensitivity, specificity, F1 score) is not applicable here.

    The document primarily focuses on establishing substantial equivalence to predicate devices for its intended use (repair of groin hernia defects) and regulatory classification.

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