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510(k) Data Aggregation

    K Number
    K170648
    Device Name
    ANTHEM CR Total Knee System
    Manufacturer
    Smith & Nephew, Inc.
    Date Cleared
    2017-05-11

    (69 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K142807,K112941,K041825,K951987
    Why did this record match?
    Device Name :

    ANTHEM CR Total Knee System

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

    The Smith & Nephew ANTHEM CR Total Knee System is intended for total knee arthroplasty.

    Device Description

    The ANTHEM CR Total Knee System is a cruciate retaining implant design that includes CoCr femoral components and titanium tibia baseplate components, each available in multiple sizes; femorals: sizes 3 – 8 standard and 1 – 6 narrow with right and left options; tibia baseplates: size 1 – 8 with right and left options. The narrow femoral options have a slightly narrower ML width of the posterior condyles than the standard options of the same size. Additionally, a range of Genesis II CR Deep Flex Inserts (sizes 1-8; thicknesses 9-18mm - K041825) have been rebranded as Anthem CR HF Inserts to provide consistency within the total knee system. Both the Genesis II CR HF and Anthem CR HF branded inserts will remain on the market simultaneously with identical component designs. These inserts are singleuse prescription devices made of ultra-high molecular weight polyethylene (UHWMPE, ASTM F648) and sterilized via ethylene oxide (ETO). The existing GENESIS II Patellas (sizes: 26 – 35mm; K951987) and ANTHEM Tibia Baseplates (K142807) are used in conjunction with the new femoral to complete the ANTHEM CR Total Knee System. The GENESIS II CR Deep Flexion Inserts (sizes: 1-8; thickness: 11-30mm; K041825) in conjunction with the GENESIS II Tibia baseplate (sizes: 1-8 with left and right options; K951987) can also be substituted in the ANTHEM CR Total Knee System.

    AI/ML Overview

    The provided document is a 510(k) summary for the "ANTHEM® CR Total Knee System." It details the device's characteristics and its proposed equivalence to existing predicate devices. However, this document does not describe an AI or software as a medical device (SaMD), but rather a physical medical device (a knee prosthesis).

    Therefore, I cannot extract information related to acceptance criteria or studies proving compliance for an AI-powered device, as the content is about a traditional orthopedic implant. The questions you've asked (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set) are relevant to AI/SaMD and are not covered in this type of 510(k) submission for a physical implant.

    In summary, there is no information in the provided text to fulfill your request for an AI/SaMD acceptance criteria and study description.

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