LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K143204
    Device Name
    AOS Clavicle Intramedullary Device
    Manufacturer
    ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
    Date Cleared
    2015-06-03

    (208 days)

    Product Code
    HSB,JDW
    Regulation Number
    888.3020
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K081832,K971783,K103001
    Why did this record match?
    Reference Devices :

    K081832, K971783

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

    The AOS Clavicle Intramedullary Device is intended to be used to repair an acute fracture, mal-union, or non-union of the Clavicle.

    Device Description

    The system consists of an intramedullary titanium device and a fully threaded 2.7mm cortical screw for Clavicle fracture fixation.

    AI/ML Overview

    The provided document is a 510(k) summary for the AOS Clavicle Intramedullary Device. It describes the device, its indications for use, and its substantial equivalence to predicate devices based on preclinical testing.

    However, the document does not contain any information about acceptance criteria, device performance metrics, or a study involving human readers or AI algorithms. The "preclinical testing" mentioned is mechanical testing (a four-point bend test) and is used to demonstrate substantial equivalence to a predicate device, not to assess performance against specific clinical acceptance criteria.

    Therefore, for the information requested regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details, the answer is:

    • No information is available in the provided document for these specific requests.

    The document is primarily a regulatory submission demonstrating the device's substantial equivalence for market clearance, not a clinical study report with performance metrics for diagnosis or treatment outcomes, nor does it involve any AI component.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1