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510(k) Data Aggregation

    K Number
    K032950
    Device Name
    GEM INSET PATELLAR COMPONENT
    Manufacturer
    KINAMED, INC.
    Date Cleared
    2003-12-19

    (88 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GEM INSET PATELLAR COMPONENT

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

    The Gem™ Inset Patellar Component is intended to articulate with the Gem™ Total Knee femoral component or the KineMatch™ Patello-Femoral Resurfacing Implant. The Gem" Inset Patellar Component is a single use device that is intended for cemented applications on the surgically prepared posterior patella as part of primary or revision knee arthroplasty. The Gem " Inset Patellar Component replaces the patellar articulating surface of the knee joint to simulate the normal function of the knee.

    Device Description

    Not Found

    AI/ML Overview

    This FDA 510(k) letter for the Gem™ Inset Patellar Component does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a clearance letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It focuses on regulatory compliance rather than performance studies.

    Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
    • Whether MRMC or standalone studies were done, or their results.
    • Type of ground truth used.
    • Sample size for the training set or how its ground truth was established.
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