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510(k) Data Aggregation

    K Number
    K051976
    Device Name
    PROVEN REVISION MODULAR TIBIAL TRAY
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2005-10-17

    (88 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The StelKast Proven Revision Modular Tibial Tray is intended for cemented use only in total knee replacement with the following indications:

    1. osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems;
    2. revision of failed previous reconstructions where sufficient bone stock and soft integrity are present.
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the "StelKast Proven Revision Modular Tibial Tray." This document concerns the regulatory approval of a medical device and does not contain any information about acceptance criteria, device performance studies, or AI/software analysis.

    Therefore, I cannot fulfill your request for information regarding:

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

    This document is solely about the FDA's determination of substantial equivalence for a physical medical implant (a knee joint component) to a legally marketed predicate device, allowing it to be marketed. It does not involve any AI or software-based diagnostic or prognostic device, or performance studies that would typically include the details you are asking for.

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