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510(k) Data Aggregation

    K Number
    K123403
    Device Name
    AXSOS PROXIMAL LATERAL TIBIA LONG PLATES
    Manufacturer
    Stryker Trauma AG
    Date Cleared
    2013-03-20

    (135 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K061012,K050512
    Predicate For
    K140430
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AxSOS Locking Plate System is intended for use in long bone fracture fixation. The system is indicated for fixation of long bone fractures including but not limited to fractures of the humerus, tibia and femur.

    Device Description

    This Special 510(k) submission is a line extension to address modifications made to the AxSOS Locking Plate System which was cleared in K061012. This line extension is to add tibia long plates to the existing size range of the AxSOS Locking Plate System. These monoaxial long plates will be known as AxSOS Proximal Lateral Tibia Long Plates and will be available in four length sizes in left and right configurations.

    AI/ML Overview

    The provided text describes a Special 510(k) submission for a line extension to the AxSOS Locking Plate System (K123403), adding "AxSOS Proximal Lateral Tibia Long Plates." This submission aims to demonstrate substantial equivalence to previously cleared predicate devices.

    Acceptance Criteria and Device Performance (Table):

    Criterion TypeAcceptance CriteriaReported Device Performance
    Risk AnalysisCompliance with ISO 14971:2007 "Medical Devices-Application of risk management to medical devices."Risk analysis was performed according to the requirements of ISO 14971:2007. Records are retained in the design history file.
    Material & DesignSubstantial equivalence to predicate devices (AxSOS Proximal Lateral Tibia Plates from K061012 and SPS Proximal Lateral Tibia Plates from K050512) in terms of intended use, design, materials, and operational principles.Finite Element Analysis (FEA) was used to identify the worst-case for plate loading. Testing was performed as per ASTM F382-99 to demonstrate equivalence. Static strength testing (axial compression) and fatigue strength testing (axial loading) were conducted. Results were used to evaluate median fatigue limits and dynamic stiffness, substantiating equivalence to the comparative proximal lateral tibia plates of the Stryker Plating System (K050512). The document states substantial equivalence to the predicate devices in intended use, design, materials, and operational principles. The tests performed are meant to support this claim for the new plates.
    Mechanical (Static Strength)To demonstrate equivalence to predicate device.Static strength testing using axial compression was performed. Results were used to evaluate equivalence. Specific quantitative acceptance criteria or results are not provided in the summary.
    Mechanical (Fatigue Strength)To demonstrate equivalence to predicate device.Fatigue strength testing using axial loading was conducted. Results were used to evaluate median fatigue limits and dynamic stiffness, substantiating equivalence. Specific quantitative acceptance criteria or results are not provided in the summary.

    Study Information:

    The document describes non-clinical testing to demonstrate substantial equivalence, rather than a clinical study evaluating the device's performance in patients in the context of typical AI/ML medical device submission.

    1. Sample size used for the test set and the data provenance: Not applicable. This submission focuses on a mechanical device (bone plate) and uses non-clinical testing (mechanical testing, FEA) rather than clinical data from a "test set" of patients or data.
    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and physical measurements, not expert clinical interpretation.
    3. Adjudication method for the test set: Not applicable.
    4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a bone plate, not an AI/ML diagnostic or therapeutic device.
    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not involve an algorithm.
    6. The type of ground truth used: For mechanical properties, the "ground truth" is established by adherence to recognized engineering standards (ASTM F382-99) and by comparison to the established performance of the predicate devices.
    7. The sample size for the training set: Not applicable. This is not an AI/ML device, so there is no "training set."
    8. How the ground truth for the training set was established: Not applicable.
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