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510(k) Data Aggregation

    K Number
    K951185
    Device Name
    NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE
    Manufacturer
    ZIMMER, INC.
    Date Cleared
    1996-03-15

    (365 days)

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

    NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE

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

    The device is intended to reduce or relieve pain and restore function and motion to the knee joint.

    Device Description

    The NexGen™ Complete Knee Solution, 9 mm articular surfaces are made of molded ultra-high molecular-weight polyethylene (UHMWPE). As with the MG II Knee, each articular surface is snapped into one of a series of the NexGen Knee tibial plates. The components are curved in both the frontal and sagittal planes. The posterior stabilized version having slightly more curvature in the anterior portion of the sagittal plane.

    AI/ML Overview

    This document describes a 510(k) summary for the NexGen™ Complete Knee Solution, 9 mm Tibial Articular Surfaces. It's a submission for a medical device (knee implant components), not an AI/ML device, and therefore the requested information fields related to AI/ML study methodologies (such as acceptance criteria for AI performance, sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, etc.) are not applicable.

    The document primarily focuses on demonstrating substantial equivalence to predicate devices, which is the standard pathway for certain medical devices.

    Here's a breakdown of the relevant available information based on your request, highlighting why some fields are not applicable:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implied)Reported Device Performance
    Basic Geometric Shape Equivalence: The 9 mm tibial articular surfaces should have a similar basic geometric shape to the predicate device.The 9 mm tibial articular surfaces have the same basic geometric shape as the predicate device (MG II® Total Knee System and Insall/Burstein® II Modular Knee System).
    Intended Use Equivalence: The device's intended use should be similar to the predicate device.The 9 mm tibial articular surfaces have the same intended use (reduce or relieve pain and restore function and motion to the knee joint) as the predicate device.
    Material Equivalence: The device's material should be similar to the predicate device.The 9 mm tibial articular surfaces are made of molded ultra-high molecular-weight polyethylene (UHMWPE), consistent with the material of the predicate device (implied, as this is a standard material for such components).
    Safety and Effectiveness (Clinical Equivalence): The device is expected to achieve satisfactory clinical results, comparable to the predicate device."Numerous studies reported in the literature for the predicate devices indicate that satisfactory results have been obtained through the use of 9 mm tibial articular surfaces." This implicitly supports the safety and effectiveness of the new device by demonstrating equivalence to a device with a known safety and effectiveness profile.

    2. Sample Size Used for the Test Set and Data Provenance

    • Not Applicable. This is a medical device submission based on substantial equivalence to predicate devices, not an AI/ML algorithm requiring a specific test set for performance evaluation. The "studies" mentioned refer to existing literature on the predicate devices.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    • Not Applicable. Ground truth, in the context of AI/ML, is not relevant here. The "evidence" comes from long-standing clinical use of similar devices.

    4. Adjudication Method for the Test Set

    • Not Applicable.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    • No. This type of study is for evaluating the impact of an AI algorithm on human reader performance, which is not relevant for this device submission.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    • No. This device is a physical implant, not an algorithm.

    7. The Type of Ground Truth Used

    • Clinical Outcomes/Established Performance of Predicate Devices (Implied): The "ground truth" or basis for acceptance is derived from the long-term, satisfactory clinical performance reported in the literature for the predicate MG II® Total Knee System and Insall/Burstein® II Modular Knee System, demonstrating the safety and effectiveness of similar 9 mm tibial articular surfaces.

    8. The Sample Size for the Training Set

    • Not Applicable. This conceptual framework of "training set" is for AI/ML algorithms, not for physical medical device submissions like this one.

    9. How the Ground Truth for the Training Set Was Established

    • Not Applicable.
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