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510(k) Data Aggregation

    K Number
    K010310
    Device Name
    MODIFICATION TO TRIDENT ALL POLY CUP
    Manufacturer
    HOWMEDICA OSTEONICS CORP.
    Date Cleared
    2001-03-20

    (47 days)

    Product Code
    JDI
    Regulation Number
    888.3350
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K001956
    Predicate For
    K012026
    Why did this record match?
    Reference Devices :

    K001956

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

    The Trident™ All Poly Cup is a polyethylene acetabular component that is intended to replace the bearing portion of the acetabulum in primary or revision total hip arthroplasty. This cup is designed to be cemented into the acetabulum. These acetabular cups are intended to be used with any Howmedica Osteonics' femoral head.

    Device Description

    The subject Trident™ All Poly Cup is available in Crossfire™ UHMWPE in outer diameters of 40mm to 50mm in two millimeter increments and inner diameters of 22mm, 26mm, and 32mm. The predicate device is manufactured from standard Ultra High Molecular Weight Polyethylene while the subject devices are manufactured from Crossfire™ Ultra High Molecular Weight Polyethylene. Both materials conform to ASTM F-648.

    AI/ML Overview

    The provided document is a 510(k) summary for a medical device (Trident™ All Poly Cup), which focuses on demonstrating substantial equivalence to a predicate device for regulatory approval. It is not a study that provides acceptance criteria and performance data for a diagnostic device, which is what the prompt requests.

    Therefore, the document does not contain the information needed to fill out the requested table and answer the questions about acceptance criteria, study design, expert involvement, and ground truth.

    The document does not provide information on:

    • Acceptance criteria (quantitative metrics for device performance)
    • Reported device performance (e.g., sensitivity, specificity, accuracy)
    • Sample sizes for test sets or their data provenance
    • Number/qualifications of experts to establish ground truth
    • Adjudication methods
    • Multi-reader multi-case (MRMC) comparative effectiveness studies
    • Standalone performance studies
    • Type of ground truth used (e.g., pathology, outcomes)
    • Sample size for training sets
    • How ground truth for training set was established

    The document's purpose is to outline the device modification (material change) and assert substantial equivalence to a legally marketed predicate, not to report on diagnostic performance studies based on acceptance criteria.

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