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510(k) Data Aggregation

    K Number
    K071437
    Device Name
    MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2007-09-12

    (112 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K013107,K061262,K050407,K063588,K052080,K060830
    Why did this record match?
    Reference Devices :

    K013107, K061262, K050407, K063588, K052080, K060830

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

    The KSEA MegaFix®-C Elioabsorbable Composite Interference Screw 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 MegaFix®-C Bioabsorbable Composite Interference Screw is a one-time use biodegradable implant, provided to the end user in a sterile condition, and intended for interference fixation of grafts in human cruciate ligament reconstruction. The device is a bioabsorbable composite interference screw which utilizes lactide polymer composite technology to perform the intended use.

    AI/ML Overview

    The provided text describes the KSEA MegaFix®-C Bioabsorbable Composite Interference Screw, but it does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

    The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing performance data against specific acceptance criteria. It mentions the device description, indications for use, and technological characteristics, and lists predicate devices, but no performance study details are included.

    Therefore, I cannot populate the requested table or answer the specific questions related to a study's methodology, sample sizes, ground truth, or expert involvement.

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