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510(k) Data Aggregation

    K Number
    K130832

    Validate with FDA (Live)

    Device Name
    ORTHOHELIX STAPLE SYSTEM
    Manufacturer
    ORTHOHELIX SURGICAL DESIGNS, INC.
    Date Cleared
    2013-08-15

    (142 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K070031,K993714
    Predicate For
    K142148
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The OrthoHelix™ Staple System is indicated for fixation in the hand and foot including fractures, fusions, and osteotomies.

    Device Description

    The OrthoHelix™ Staple System consists of various sizes of staples used for fixation in the hand and foot. The staples are offered in different lengths, widths, and thicknesses. All implantable devices within this system are manufactured from shape memory nickel titanium alloy.

    AI/ML Overview

    The provided text describes a medical device, the OrthoHelix™ Staple System, and its clearance process with the FDA. However, it does not include information about acceptance criteria, device performance studies, or details relevant to artificial intelligence (AI) performance evaluation.

    The document is a 510(k) summary and an FDA clearance letter for a Class II medical device (bone staple). The information provided focuses on demonstrating substantial equivalence to predicate devices through engineering calculations, finite element analysis, and mechanical/corrosion testing. This type of submission generally does not involve clinical performance studies with human subjects or AI-based analyses.

    Therefore, I cannot fulfill the request for information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or AI-related study details, as this information is not present in the provided text.

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