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510(k) Data Aggregation

    K Number
    K050868
    Device Name
    MAXLOCK
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Date Cleared
    2005-05-27

    (51 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K920738,K040598
    Predicate For
    K041879,K073624,K121001
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MaxLock Small Bone System is indicated for the repair of osteotomies and fractures of:

    • Phalanges of the hands and feet. .
    • Metacarpals and metatarsals. .
    • Carpals and tarsal bones. .
    • The wrist and ankle and, .
    • Arthrodesis of the hands, wrists, foot and ankle. .
    Device Description

    The Maxlock System includes ten (10) fixation plates and 38 screws. Plates vary in size, number of holes and in configuration. Screws vary in size by diameter and length. All plates and screws in the Maxlock System are made from Titanium Ti-6Al-4V ELI Alloy. This material conforms with ASTM F-136 Standard Specification for Wrought Titanium 6AI-4V ELI Alloy for Surgical Implant Applications. The unique X-Cross Profile and curvature of the plates are intended to better match the patients' anatomy. All edges are beveled to minimize wear on surrounding soft tissue and ligaments. The plates are contourable during surgery, to allow a better fit to the profile of bone. Plate holes are counter-sunk to lower the profile of the screw head and help minimize wear on the surrounding soft tissue and ligaments.

    AI/ML Overview

    The provided text pertains to a 510(k) premarket notification for a medical device called the "MaxLock™ Small Bone System" and does not describe software or AI-based medical device. Therefore, a characterization of acceptance criteria, device performance, and study details for an AI/software device cannot be extracted from this documentation.

    The relevant sections of the input relate to the characteristics of the hardware device, such as materials and mechanical properties, and its substantial equivalence to predicate devices, which is assessed through an entirely different process than the one outlined in the request.

    Specifically:

    • The "Performance Data" section in the input states: "FEA's confirm that the MaxLock System is substantially equivalent to its' predicate devices, and that it meets specified requirements for its' intended use."
    • "FEA" stands for Finite Element Analysis, which is a computational method used in engineering for simulating physical phenomena, not for evaluating AI algorithms or software performance.

    Therefore, I cannot fulfill your request based on the provided document.

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