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510(k) Data Aggregation

    K Number
    K982869
    Device Name
    ASCENT SYSTEM
    Manufacturer
    BIOMET, INC.
    Date Cleared
    1998-09-22

    (39 days)

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

    ASCENT SYSTEM

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

    The indications for use of the Ascent Knee are the same as for other conventional knee prostheses. These include the relief of pain and restoration of motion due to non-inflammatory degenerative joint diseases, theumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. Standard surgical and rehabilitative procedures are indicted with this device. This device is for use with bone cement.

    Device Description

    The Ascent Knee System is a Co-Cr-Mo femoral component, a Ti-6Al-4V tibial component and a UHMWPE tibial bearing designed to replace a damaged or diseased knee joint. Indications include the relief of pain and restoration of motion due to non-inflammatory degenerative joint disease, rheumatoid arthritis, deformities of the knee and revisions of previously failed knee replacements. The device is intended for use with bone cement.

    AI/ML Overview

    The provided text is a 510(k) summary for the Biomet Ascent Knee System, submitted to the FDA in 1998. This document is related to market clearance for a medical device and describes its intended use and establishes substantial equivalence to existing devices.

    Crucially, this document describes a medical device, not a software algorithm or AI device. Therefore, the concepts of acceptance criteria related to algorithmic performance, test sets, ground truth, experts, adjudication methods, MRMC studies, standalone performance, and training sets, as requested in the prompt, are not applicable to this type of submission.

    This document focuses on:

    • Device Description: The physical components of the knee system.
    • Indications for Use: The medical conditions the device is intended to treat.
    • Potential Risks: General risks associated with joint replacement.
    • Substantial Equivalence: Comparing the Ascent Knee System to other legally marketed knee prostheses based on function and overall design. This is the primary "proof" for 510(k) submissions – demonstrating that the new device is as safe and effective as a predicate device.

    Therefore, I cannot provide the requested information in a table format as it pertains to algorithmic performance, because the provided text does not contain any such information.

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