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510(k) Data Aggregation

    K Number
    K081623
    Device Name
    SYNTHES RIB FIXATION SYSTEM
    Manufacturer
    SYNTHES (USA)
    Date Cleared
    2008-09-08

    (90 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K100412,K040058,K040209,K993356
    Why did this record match?
    Device Name :

    SYNTHES RIB FIXATION SYSTEM

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

    The Synthes MatrixRIB Fixation System is indicated for the fixation and stabilization of rib fractures, fusions and osteotomies of normal and osteoporotic bone.

    Device Description

    The Synthes MatrixRIB Fixation System consists of bone plates, intramedullary (IM) splints and screws. All plates, IM splints and screws are manufactured from titanium alloy. The devices are provided sterile and non-sterile.

    AI/ML Overview

    The provided text is a 510(k) summary for the Synthes MatrixRIB Fixation System, a medical device for fixing rib fractures. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    Instead, it focuses on demonstrating substantial equivalence to predicate devices through mechanical tests and engineering analyses. This is a common pathway for medical devices seeking FDA clearance, where the focus is on showing the new device is as safe and effective as existing legally marketed devices, rather than conducting new clinical trials with acceptance criteria.

    Therefore, I cannot fulfill your request for the specific details outlined (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set details) because this information is not present in the provided document.

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