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510(k) Data Aggregation

    K Number
    K013107
    Device Name
    BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
    Manufacturer
    KARL STORZ ENDOSCOPY
    Date Cleared
    2002-02-26

    (162 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    K071437
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA Bioabsorbable Interference Screw MegaFix" is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.

    Device Description

    The KSEA Bioabsorbable Interference Screw MegaFix" is biocompatible and biodegradable.

    AI/ML Overview

    I am sorry, but based on the provided document, there is no information about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone algorithm performance, or ground truth types.

    The document is a 510(k) summary for a medical device (KSEA Bioabsorbable Interference Screw Megafix™), which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed study results or performance metrics in the way you've requested. It states that "The minor differences between the KSEA Bioabsorbable Interference Screw and the predicate devices raise no new issues of safety and effectiveness, as these minor differences have no effect on the performance, function or intended use of the device." This implies a comparison to existing devices, but the specific studies and acceptance criteria are not detailed here.

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