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510(k) Data Aggregation

    K Number
    K043233
    Device Name
    GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
    Manufacturer
    EFRATGO, LTD. HI TECH BIO-SURGICAL
    Date Cleared
    2005-02-01

    (71 days)

    Product Code
    HSB
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K983814,K970097,K034002
    Predicate For
    K083648
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Gotfried PH (Physiological Hip) Nail is intended for fractured bone stabilization, fixation, and management of trochanteric (intertrochanteric and pertrochanteric), subtrochanteric, and base of neck fractures of the proximal femur.

    Device Description

    The Gotfried PH (Physiological Hip) Nail is an intramedullary nail which utilizes two proximal dynamic femoral neck screws and two distal locking bolts.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) summary for a medical device (Gotfried PH (Physiological Hip) Nail) and primarily discusses its intended use, comparison to predicate devices, and the FDA's clearance.

    The text does not contain any details on:

    • Acceptance criteria for performance metrics.
    • Performance data from a study.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts.
    • Adjudication methods.
    • MRMC comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth for any set was established.
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