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510(k) Data Aggregation

    K Number
    K203595
    Device Name
    DynaFuse Fixation System
    Manufacturer
    MedShape, Inc.
    Date Cleared
    2022-01-04

    (391 days)

    Product Code
    HWC,HTN
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K182677,K153338,K133842,K153575
    Why did this record match?
    Reference Devices :

    K182677

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

    The MedShape DynaFuse Fixation System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

    Device Description

    The proposed MedShape DynaFuse Fixation System is a sterile, single use orthopedic implant system consisting of a threaded bone fastener and washer. The DynaFuse Fixation System is designed to apply compression across a target fracture or fusion site and is intended to be used for fracture and osteotomy fixation, including joint arthrodesis. The devices provided sterile, intended for single use, and are comprised of titanium alloy and nickel-titanium.

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any clinical study details such as sample size, data provenance, expert ground truth, or adjudication methods in the context of an AI/algorithm-enabled medical device.

    The provided document is a 510(k) premarket notification for the DynaFuse Fixation System, which is a physical orthopedic implant system (a threaded bone fastener and washer). The tests mentioned (Static Torsion Test, Static Strain Test, Fatigue Strain Test, Bacterial endotoxin testing) are engineering and biocompatibility tests for physical medical devices and are not related to the performance of an AI or software algorithm.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving device meets them for an AI/algorithm-based device from this document.

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