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    K Number
    K241769
    Device Name
    Response Ortho Metaphyseal Hinge Fixator System
    Manufacturer
    Response Ortho Solutions LLC
    Date Cleared
    2024-09-18

    (90 days)

    Product Code
    KTT
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K001358,K201253
    Why did this record match?
    Applicant Name (Manufacturer) :

    Response Ortho Solutions LLC

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

    The Response Ortho Metaphyseal Fixation System is indicated for treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation.

    Device Description

    The Response Ortho Metaphyseal Hinge Fixator System is a unilateral fixation device intended for use in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The system is designed to provide low profile and comprehensive solution invasively. Implants, reusable instruments, accessories, case&tray are included in the system. Products are non-sterile and implants that exist in the set, are single use. Instruments that are in the system, can be used repeatedly after cleaning and sterilization.

    AI/ML Overview

    The provided text describes the Response Ortho Metaphyseal Hinge Fixator System, a medical device for orthopedic use. This document does not contain information related to AI/ML software, and therefore, the entire prompt requesting details about AI/ML acceptance criteria and a study proving device meets acceptance criteria cannot be fulfilled.

    The text focuses on the device's indications for use, technological characteristics compared to predicate devices, and non-clinical tests performed to demonstrate substantial equivalence. These tests include:

    • Determination and Comparison of Stiffness for Response Ortho Metaphyseal Hinge Fixator and EBI XFIX DFS Metaphyseal Correction System Constructs using Half Pins
    • Evaluation of The Response Ortho Metaphyseal Hinge Fixator System and EBI XFIX DFS Metaphyseal Correction System Bridging Element Fatigue
    • Evaluation of Function and Strength for Response Ortho Metaphyseal Hinge Fixator Distraction Mechanism under Constant Loading
    • Evaluation of Response Ortho Half Pin Performance

    The conclusion states that the device is substantially equivalent to predicate devices based on these non-clinical tests.

    Therefore, I cannot provide the requested information regarding acceptance criteria and studies related to an AI/ML device.

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