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510(k) Data Aggregation

    K Number
    K123926
    Device Name
    METASURG NITINOL STAPLE IMPLANT
    Manufacturer
    METASURG
    Date Cleared
    2013-05-03

    (134 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K070031,K993714
    Why did this record match?
    Device Name :

    METASURG NITINOL STAPLE IMPLANT

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

    The Metasurg Nitinol Staple implant is indicated for fixation and arthrodesis of the associated bones and joints of the hands and feet.

    The Metasurg Nitinol Staple implants are intended for single use only.

    Device Description

    The Metasurg Nitinol Staple Implant is a one piece single use nickel titanium alloy bone fixation device intended to be permanently implanted. The device is indicated for the fixation of osteotomies and joint arthrodesis of the hands and feet. The implant consists of two legs connected by a bridge and is offered in multiple combinations of bridge widths and leg lengths to accommodate various anatomies.

    AI/ML Overview

    This document does not contain information about studies measuring device performance against acceptance criteria in the way a diagnostic AI device would. This 510(k) pertains to a Metasurg Nitinol Staple Implant, which is a physical, implantable medical device for bone fixation, not an image analysis or diagnostic software.

    The document states that substantial equivalence was established through:

    • "A design, dimensional comparison"
    • "standardized tests"

    However, it does not provide details of what those standardized tests were, the specific acceptance criteria for those tests, or the results. It merely states that these comparisons and tests were performed "to establish substantial equivalence in terms of intended use and indications for use, material, design and function to the legally marketed predicate devices."

    Therefore, I cannot populate the table or answer the specific questions related to AI device performance evaluation, such as sample sizes for test/training sets, expert adjudication, MRMC studies, or standalone algorithm performance.

    The information provided is typical for a 510(k) submission for a physical medical device, focusing on substantial equivalence to predicate devices based on design, materials, and intended use, rather than a detailed performance study with acceptance criteria as would be presented for a diagnostic algorithm.

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