LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K141121
    Device Name
    AXSOS 3 TI LOCKING PLATE SYSTEM
    Manufacturer
    Stryker Trauma AG
    Date Cleared
    2014-06-20

    (51 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K123964,K133440,K013248,K050646,K083032,K041533
    Why did this record match?
    Reference Devices :

    K123964, K133440

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

    The AxSOS 3 Ti Locking Plate System is intended for long bone fracture fixation. Indications include:
    • Diaphyseal, metaphyseal, epiphyseal, extra- and intra-articular fractures
    • Non-unions and malunions
    • Normal and osteopenic bone
    • Osteotomies
    • Periprosthetic fractures of the femur and proximal tibia

    Device Description

    This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market additional plates and screws within the AxSOS 3 Ti Locking Plate System. The AxSOS 3 Ti Locking Plate System includes anatomically contoured monoaxial locking plates. The 5.0mm System consists of the Distal Lateral Femur Plate (K123964). The 4.0mm System comprises the Proximal Lateral Tibia Plate (K123964) as well as the subject devices being the Distal Anterolateral Tibia Plate, the Distal Medial Tibia Plate and the Proximal Medial Tibia Plate. The system includes four (4) types of screws available in various diameter and thread length: locking, cortical, cancellous (K123964 & K133440) as well as the subject periprosthetic screws. The plates have been designed with holes that can accommodate either a locking or non-locking screw both at the peri-articular end and along the shaft of the plates also have an oblong hole located at the metaphyseal junction used to aid in positioning. The subject components will be available sterile and non-sterile.

    AI/ML Overview

    The provided text describes a medical device, the "AxSOS 3 Ti Locking Plate System," and its clearance process through a 510(k) submission to the FDA. This submission focuses on establishing substantial equivalence to previously marketed predicate devices rather than demonstrating novel performance against defined acceptance criteria through a clinical or standalone study.

    Therefore, many of the requested categories regarding acceptance criteria, study details, and expert involvement are not applicable to the information provided.

    Here's a breakdown of the relevant and non-applicable information based on the input:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Not explicitly stated as such for performance)Reported Device Performance (Non-Clinical Testing)
    Mechanical properties as per ASTM F382-99 (reapproved 2008)Demonstrated substantial equivalence to currently marketed predicate devices (Synthes LCP Distal Tibia Plates, Synthes 3.5/4.5MM LCP Medial Proximal Tibia Plates, Peri-Loc Bone Plating and Screw System).
    Mechanical properties as per ASTM F543-07Demonstrated substantial equivalence to currently marketed predicate devices (Synthes Peri-Prosthetic Screws).
    Intended UseSubstantially equivalent to predicate devices for long bone fracture fixation.
    Design, Materials, and Operational PrinciplesSubstantially equivalent to predicate devices.

    2. Sample size used for the test set and the data provenance:

    • Not Applicable. No test set of patient data (e.g., images for an AI device) was used. The "test set" in this context refers to the worst-case subject plates and screws used for non-clinical, mechanical testing. The provenance of these physical samples is not specified, but they would be manufactured by the sponsor (Stryker Trauma AG).

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    • Not Applicable. As no patient data test set was used, no experts were involved in establishing ground truth for such data. Mechanical testing relies on standardized test methods (ASTM) and engineering evaluations rather than expert consensus on medical conditions.

    4. Adjudication method for the test set:

    • Not Applicable. No patient data test set requiring adjudication was used.

    5. 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 device is a bone plate and screw system, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and related metrics are irrelevant.

    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • Not Applicable. This device is a physical medical implant, not an algorithm.

    7. The type of ground truth used:

    • For the non-clinical testing, the "ground truth" was derived from established mechanical standards and specifications (ASTM F382-99 and ASTM F543-07) and comparison to the performance of predicate devices. There is no biological "ground truth" in the clinical sense for this type of submission.

    8. The sample size for the training set:

    • Not Applicable. No training set, in the context of machine learning or AI, was used for this type of medical device submission.

    9. How the ground truth for the training set was established:

    • Not Applicable. As no training set was used, no ground truth needed to be established for it.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1