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510(k) Data Aggregation

    K Number
    K002796
    Manufacturer
    Date Cleared
    2000-09-28

    (21 days)

    Product Code
    Regulation Number
    888.3360
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    MODIFICATION TO PROVIDENT HIP SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. Hip arthritis caused by rheumatoid disease, noninflammatory degenerative joint disease (osteoarthritis) or traumatic arthritis from biologic or mechanical trauma to the hip.
    2. Correction of functional deformity.
    3. Treatment of nonunions, femoral neck and trochanteric fractures of the proximal femur.
    4. Difficult clinical management problems involving persistent pain and physical impairment where conventional arthrodesis is not likely to achieve satisfactory results.
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for the 'Provident Hip System'. It confirms that the device is substantially equivalent to previously marketed devices and outlines the indications for use.

    Based on the provided text, there is no information available regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a regulatory approval, not a scientific study report. It mentions the "indications for use" for which the device was cleared, but it does not detail any performance metrics, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an acceptance criteria assessment.

    Therefore, I cannot provide the requested information.

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    K Number
    K001745
    Manufacturer
    Date Cleared
    2000-07-27

    (49 days)

    Product Code
    Regulation Number
    888.3360
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO PROVIDENT HIP SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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