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510(k) Data Aggregation

    K Number
    K022139
    Device Name
    HIP TOOL IMPLANT
    Manufacturer
    ORTHOPEDIC SCIENCES, INC
    Date Cleared
    2002-09-23

    (83 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K982222,K000066,K011459,K970503,K012162,K963700,K993106,K983988,K972219,K982553,K970258
    Why did this record match?
    Device Name :

    HIP TOOL IMPLANT

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

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

    Device Description

    The Hip Tool™ Implant is a component of the Hip Tool™ Bone Graft Stabilization System (BGSS). The complete system consists of the Hip Tool™ Implant, and a series of manual surgical instruments (Class 1, exempt, not a subject of this submission) intended to assist in core decompression of osteonecrotic bone in the femoral head. The Hip Tool™ Implant consists of a bone plate and barrel and a graft compression screw and locking screw. The plate is attached to the femur using standard 4.5 mm cortical bone screws. The Hip Tool™ Implant is intended to stabilize a bone graft that is placed during the surgical procedure.

    AI/ML Overview

    The provided text is a 510(k) summary for the "Hip Tool" Implant. It describes the device, its intended use, material composition, and
    establishes substantial equivalence to predicate devices. However, this document does not contain information about
    acceptance criteria, device performance studies, or details regarding the methodologies for evaluating device performance
    such as sample sizes, ground truth establishment, or expert adjudication.

    Therefore, I cannot fulfill your request for the following information based on the provided text:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sized used for the test set and the data provenance
    3. Number of experts used to establish the ground truth for the test set and their qualifications
    4. Adjudication method for the test set
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers with/without AI assistance
    6. If a standalone (algorithm only) performance study was done
    7. The type of ground truth used
    8. The sample size for the training set
    9. How the ground truth for the training set was established

    The document focuses on regulatory information for a medical device (a bone plate) and demonstrates its equivalence to existing
    marketed devices and a surgical procedure. It addresses material standards (ASTM F138, ANSI/AAMI/ISO 11137) as part of conformance,
    but these are material and sterilization standards, not performance criteria for diagnostic accuracy or clinical outcomes
    in the way your request implies for a "study that proves the device meets acceptance criteria" related to performance metrics.
    The device itself is a physical implant, not an AI or diagnostic tool that would typically have acceptance criteria like
    sensitivity, specificity, or reader improvement.

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