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510(k) Data Aggregation

    K Number
    K030368
    Device Name
    KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2003-03-20

    (44 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MegaFix-T™ Titanium Interference Screw is intended for tibial and femoral fixation (primary anchorage) of tendon grafts in anterior and posterior cruciate ligament reconstruction.

    Device Description

    The MegaFix-T™ is composed of titanium, which is commonly used in medical devices for a wide range of application and has a long history of biocompatibility for human use.

    AI/ML Overview

    The provided documents are a 510(k) summary and FDA clearance letter for a medical device called the "Karl Storz MegaFix-T™ Titanium Interference Screw." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing the detailed performance studies typically associated with AI/software devices.

    Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not part of this 510(k) submission.

    This document describes a traditional medical device (an interference screw for ACL reconstruction), not an AI/software device. As such, the specific metrics and study designs relevant to AI/software device validation (e.g., AUC, sensitivity, specificity, MRMC studies, ground truth establishment by experts for imaging data) are not applicable and are not found within this 510(k) submission.

    The submission focuses on:

    • Device Identification: Karl Storz MegaFix-T™ Titanium Interference Screw
    • Intended Use: Tibial and femoral fixation of tendon grafts in anterior and posterior cruciate ligament reconstruction.
    • Device Description: Composed of titanium, used in medical devices for biocompatibility.
    • Substantial Equivalence: Demonstrated to predicate devices due to similar basic features and intended use. Minor differences raise no new issues of safety and effectiveness.

    There are no details on acceptance criteria and a study that proves the device meets the acceptance criteria in the context of an AI/software device. The safety and effectiveness for this device are based on its material (titanium) and its substantial equivalence to previously cleared devices.

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