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    K Number
    K171624
    Device Name
    IXOS Radius Plate System
    Manufacturer
    Stuckenbrock Medizintechnik GmbH
    Date Cleared
    2018-03-29

    (300 days)

    Product Code
    HRS
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K133246,K051567
    Why did this record match?
    Device Name :

    IXOS Radius Plate System

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

    The IXOS Radius Plate System is intended for surgical procedures in which internal fixation by implants is required for aligning, reconstruction and stabilizing bone tissue.

    It is used in particular for fixing intra- and extra articular acute fractures of the distal radius, in particularly

    • · Type A2 Colles fractures
    • · Type A3 fractures
    • · Type B1 fractures
    • · Type B2 Barton fractures
    • · Type B3 Smith or reversed Barton fractures
    • · Type C1 fractures
    • · Type C2 fractures
    • · Type C3 fractures

    and in osteotomies of the distal radius.

    Device Description

    The IXOS Radius Plate System is used for aligning, reconstructing and stabilizing bone tissue. It is used in the field of hand, accident and reconstructive surgery and orthopedics especially for the fixation of acute distal intra- and extra-articular fractures of the radius.

    AI/ML Overview

    I am sorry, but the provided text is a summary of an FDA 510(k) clearance for a physical medical device (IXOS Radius Plate System), not an AI/ML-driven software as a medical device.

    Therefore, the input does not contain information about:

    • Acceptance criteria and reported device performance related to an AI/ML algorithm.
    • Sample sizes, data provenance, ground truth establishment, or expert involvement for an AI/ML model.
    • Any AI-related studies such as MRMC comparative effectiveness or standalone algorithm performance.

    The document discusses the substantial equivalence of a bone fixation plate system to predicate devices based on material, design, and mechanical testing (static and dynamic 4-point bending tests), and biocompatibility.

    As such, I cannot fulfill your request for information about the acceptance criteria and studies for an AI/ML device based on the given text.

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