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510(k) Data Aggregation

    K Number
    K073527

    Validate with FDA (Live)

    Device Name
    VARIAX ELBOW SYSTEM
    Manufacturer
    HOWMEDICA OSTEONICS CORP
    Date Cleared
    2008-02-14

    (59 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K063875,K062498,K050512,K040022
    Predicate For
    K092671,K093433,K101056,K132502,K141301
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The VariAx™ Elbow System is intended for fracture fixation of long bones. Indications include:

    • Distal Humerus
    • Proximal Ulna
    Device Description

    This submission is a line extension to the Stryker® Plating System. The components of the VariAx™ Elbow System are intended to add different types of plates and screws to the Stryker® Plating System portfolio.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the VariAxTM Elbow System, focusing on its substantial equivalence to predicate devices for regulatory clearance. It describes the device, its intended use, and its substantial equivalence to other Stryker plating systems.

    Therefore, I cannot provide the requested information, including:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number of experts or their qualifications for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study or effect size.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
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