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510(k) Data Aggregation

    K Number
    K993714
    Device Name
    MEMOGRAPH STAPLE, WARM SYSTEM
    Manufacturer
    BIOMEDICAL ENT., INC.
    Date Cleared
    2000-02-25

    (115 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic (OR)
    Reference & Predicate Devices
    K902307
    Why did this record match?
    Device Name :

    MEMOGRAPH STAPLE, WARM SYSTEM

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

    The Memograph® Staple is intended for:

    l ) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) fixation of soft tissue to bone such as anterior cruciate reconstruction.

    Device Description

    The Memograph® Staple system consists of two and four prong staples for 1) hand and foot bone fragment and osteotomy fixation and joint arthrodesis, 2) fixation of proximal tibial metaphysis osteotomy and 3) fixation of soft tissue to bone such as in anterior crucate ligament reconstruction. The staple is fabricated from Nitinol. The staple's prongs are parallel during insertion. Application of an electrical current from the Warmsystem to the staple causes its prong to deflect inward. This inward deflection causes staple retention and compression across the osteotomy or arthrodesis site.

    AI/ML Overview

    This document K993714 details the 510(k) summary for the Memograph® Staple System. However, it does not contain the information required to populate the acceptance criteria and study details as requested. This document is a regulatory submission for premarket notification, focusing on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with acceptance criteria.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results or effect size.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    The provided text focuses on the device description, intended use, and substantial equivalence to legally marketed predicate devices, which is typical for a 510(k) submission. It does not include information about specific performance studies with detailed acceptance criteria, test sets, or ground truth establishment.

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