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510(k) Data Aggregation

    K Number
    K141548
    Device Name
    HIGH TIBIAL OSTEOTOMY SYSTEM
    Manufacturer
    NEWCLIP TECHNICS
    Date Cleared
    2015-01-30

    (233 days)

    Product Code
    HRS,HWC
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K032187,K041601,K063095
    Predicate For
    K173746,K213214
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The High Tibial Osteotomy System is indicated for fixation of high tibial osteotomy.

    Device Description

    The High Tibial Osteotomy System consists of a pre-contoured plate and self-tapping screws in various sizes for high tibial osteotomy. The plates and screws are manufactured from titanium alloy and color anodized. The High Tibial Osteotomy System will be provided sterile.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device (High Tibial Osteotomy System), not a study report for an AI/ML powered device. Therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML application.

    Specifically, the document states:

    • "No clinical studies were performed." (Page 4, Section 8, "Clinical Test Summary:")
    • It refers to "Non-clinical Test Summary" which lists "Comparative fatigue compression tests," "Comparative static compression tests," "Geometric analysis of the subject and predicate screws," and "Torsional engineering analysis of plates." These are engineering and material tests, not performance studies for an AI/ML algorithm.

    Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the content of this document.

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