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510(k) Data Aggregation

    K Number
    K970200
    Device Name
    RELIANCE PF FEMORAL STEMS
    Manufacturer
    HOWMEDICA CORP.
    Date Cleared
    1997-04-09

    (78 days)

    Product Code
    LZO,JDI,KWL,KWY
    Regulation Number
    888.3353
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K903563,K936126,K936127
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Reliance® PF stem is a femoral component of a Total Hip System. It is intended to be used for primary or secondary reconstruction of the proximal femur damaged as a result of inflammatory, non-inflammatory, or traumatic joint disease. The Reliance® PF stem is intended to be used in conjunction with Howmedica's V40 femoral heads, Acetabular components, and unipolar and bipolar components. The stem can be press-fit into the proximal femur for fixation by mechanical interlock, or affixed with bone cement.

    Device Description

    The Reliance® PF stem is a femoral component of a Total Hip System. It is manufactured from forged cobalt-chromium-molybdenum (Vitallium®) alloy.

    AI/ML Overview

    This document is a 510(k) summary for a medical device (Reliance® PF Femoral Stems) and not a study describing the validation of an AI/ML powered device. As such, it does not contain the specific information requested in your prompt regarding acceptance criteria and performance studies for an AI/ML device.

    Here's why and what information is available:

    • Device Type: The Reliance® PF Femoral Stem is a physical orthopedic implant (a metallic hip stem), not a software or AI/ML-driven diagnostic or therapeutic device.
    • Purpose of Document: A 510(k) summary is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It focuses on equivalence in intended use, materials, design, and operational principles, rather than detailed AI performance metrics.
    • Acceptance Criteria/Performance Data: The document mentions "Testing has demonstrated that the endurance load exceeds the Semlitsch minimum of 630 lbs." This is a mechanical engineering acceptance criterion related to the physical strength and durability of the hip stem, not an AI performance metric like sensitivity, specificity, or AUC.

    Therefore, I cannot provide a table of acceptance criteria and reported device performance (in the context of AI), or details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to this type of device and document.

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