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510(k) Data Aggregation

    K Number
    K030577
    Device Name
    PROVEN MODULAR TIBIAL TRAY
    Manufacturer
    STELKAST COMPANY
    Date Cleared
    2003-03-25

    (29 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K980276,K000113
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Total knee replacement due to 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.
    3. For cemented use only.
    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for a medical device (StelKast Proven Modular Tibial Tray). This type of document does not typically contain the detailed technical study information required to answer your specific questions about acceptance criteria and device performance studies.

    A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, as opposed to providing detailed clinical trial results or performance studies with specific statistical metrics, ground truth establishment, or expert reviews as you've outlined.

    Therefore, I cannot provide a response with the information you requested based on the input document. The document confirms the FDA's clearance of the device based on substantial equivalence but does not elaborate on the specific performance studies, their methodology, or results.

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