LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K955761
    Device Name
    TIBIA ORTHONAIL
    Manufacturer
    ORTHOLOGIC CORP.
    Date Cleared
    1996-03-13

    (86 days)

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

    The Tibia OrthoNail is indicated for stabilizing tibral fractures.

    Device Description

    The Tibia OrthoNail is a solid cylinder. The Tibia OrthoNail is available in diameters, 9 - 14 mm and in lengths of 200 - 425 mm. The device is designed to accept transfixing screws. End caps are provided. For use during insertion an Impacting Anvil is provided. An Alignment Tower is provided to ensure proper alignment of transfixation screw holes. The Anvil has an internal proximal thread for attachment of a slaphammer that is used for insertion or distraction.

    AI/ML Overview

    This document is a 510(k) premarket submission for a medical device (Tibia OrthoNail), not a study evaluating the performance of an AI/ML device. Therefore, it does not contain information related to acceptance criteria or studies proving device performance in the context of AI/ML.

    The provided text describes the device, its classification, and makes a claim of substantial equivalence to predicate devices based on technological characteristics (materials, dimensions, design features), but it does not include:

    • Acceptance criteria for AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
    • Any study details, sample sizes, ground truth establishment, or expert involvement relevant to AI/ML device evaluation.
    • Information about training sets, test sets, or comparative effectiveness studies involving AI assistance.

    Essentially, the document focuses on regulatory approval for a physical medical implant, not the assessment of an intelligent algorithm.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1