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    K Number
    K961379
    Device Name
    DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)
    Manufacturer
    DEPUY, INC.
    Date Cleared
    1996-06-18

    (69 days)

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

    DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501)

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

    The DcPuy AMK Porous Coated CRX Tibial Tray is intended to be used as the tibial component in cemented total knee arthroplasty.

    Device Description

    The DePuy AMK Porous Coated CRX Tibial Tray is a cast cobalt chrome tibial tray available in four standard sizes and five "plus" tibial sizes. The tray has a fixed, tapered, cylindrical central stem and two posterior fins originating at the central stern, and porous coating on the undersurface.

    AI/ML Overview

    I am sorry, but the provided text describes a medical device (DePuy AMK Porous Coated CRX Tibial Tray) and its regulatory submission for substantial equivalence. It does not contain any information regarding acceptance criteria or a study related to device performance in an AI or diagnostic context.

    Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study details as none of that information is present in the provided text.

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