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    K Number
    K063709
    Device Name
    TS-BONE HIP TOOL
    Manufacturer
    ORTHOPEDIC SCIENCES, INC
    Date Cleared
    2007-01-04

    (21 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Special
    Panel
    Orthopedic
    Reference & Predicate Devices
    K022139
    Why did this record match?
    Reference Devices :

    K022139

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

    The TS-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) summary for the TS-Bone Hip Tool™. It describes an orthopedic device intended to stabilize a bone graft, not an AI/ML powered device. As such, the requested information regarding acceptance criteria and studies for device performance as it relates to AI/ML devices, such as sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable to this submission.

    The 510(k) process for this type of device typically focuses on substantial equivalence to a predicate device based on manufacturing materials, design, intended use, and mechanical testing, rather than algorithmic performance.

    Therefore, I cannot provide the requested table and details because the provided document does not contain information about an AI/ML powered device or a study comparing its performance to acceptance criteria in the manner described by your prompt.

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