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510(k) Data Aggregation

    K Number
    K172052
    Manufacturer
    Date Cleared
    2017-12-13

    (160 days)

    Product Code
    Regulation Number
    888.3030
    Reference & Predicate Devices
    Predicate For
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

    Device Description

    The Arthrex DynaNite Nitinol Staple is a Nickel Titanium (Nitinol) bone fixation device intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomies.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for the "Arthrex DynaNite Nitinol Staple." This document focuses on demonstrating substantial equivalence to predicate devices, rather than proving a new device's absolute performance against specific acceptance criteria for a novel AI/software function.

    Therefore, the information required to answer the prompt regarding AI/software device acceptance criteria and a study proving those criteria is not present in the provided text. The document pertains to a traditional medical device (a bone fixation staple), and the "Performance Data" section discusses mechanical properties, corrosion, and biocompatibility, not AI performance.

    Hence, I cannot populate the requested tables and information.

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