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510(k) Data Aggregation

    K Number
    K193057
    Device Name
    ATTUNE All-Polyethylene Tibia
    Manufacturer
    DePuy Ireland UC
    Date Cleared
    2020-01-30

    (90 days)

    Product Code
    JWH
    Regulation Number
    888.3560
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K101433,K140881,K103756,K943462,K950010,K961685,K971189
    Why did this record match?
    Device Name :

    ATTUNE All-Polyethylene Tibia

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

    Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

    Device Description

    The subject device is an all polyethylene tibia component made from AOX Polyethylene that mates with existing ATTUNE cemented (K101433) and cementless (K140881) femoral components, and existing ATTUNE patella components (K103756).

    AI/ML Overview

    The document provided is a 510(k) premarket notification for a medical device, the ATTUNE All Polyethylene Tibia, and does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.

    Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance data.

    Here's why the requested information cannot be extracted from this document:

    • Device Type: The device is a "Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis," which is a physical implant for total knee replacement, not a software or AI/ML-driven device.
    • Study Type: The studies mentioned are "non-clinical tests" related to mechanical properties and material performance of the physical implant (e.g., Contact Area/Pressure, Wear, Constraint on tibiofemoral interface, Spine Fatigue, C2 Fixation Testing, Range of Motion, and bacterial endotoxin testing). These are not studies to evaluate AI/ML performance.
    • Lack of AI/ML Specifics: There is no mention of AI, machine learning, algorithms, or any form of software performance evaluation.
    • Clinical Testing: The document explicitly states: "No clinical testing was conducted to demonstrate substantial equivalence." This further indicates that the type of clinical performance study typically associated with AI/ML device validation (e.g., impact on human readers, standalone performance) was not performed.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance tables, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this 510(k) submission for a knee implant.

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