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510(k) Data Aggregation

    K Number
    K053492
    Device Name
    BIODUCT
    Manufacturer
    BIODUCT, LLC
    Date Cleared
    2007-04-12

    (483 days)

    Product Code
    MAI
    Regulation Number
    888.3030
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K002406,K991715,K980681,K955768,K003070,K983577
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BioDuct's Meniscal Fixation Device is intended for fixation of longitudinal vertical meniscus (bucket handle) lesions located in the vascularized (red-white) zone of the meniscus when used with suture.

    Device Description

    BioDuct's Meniscal Fixation Device is an arthroscopically implanted, cannulated, bioabsorbable (PLA) device used with suture, and is available in sizes ranging from 5 to 14 mm long. The Meniscal Fixation Device is designed to be placed between the synovium and a lesion located in less well vascularized (red-white) areas of the meniscus.

    AI/ML Overview

    The provided text describes a medical device, BioDuct's Meniscal Fixation Device, and its 510(k) submission. However, it does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or software.

    The document discusses:

    • Device Description: An arthroscopically implanted, cannulated, bioabsorbable device used with suture for meniscal fixation.
    • Indications for Use: Fixation of longitudinal vertical meniscus lesions in the vascularized (red-white) zone, when used with suture.
    • Performance Claim: Mechanical testing results indicate the device, when used with suture, improves the 3-month fixation strength of the lesion compared to trephination and suture alone as shown in the canine model.
    • Substantial Equivalence: Based on similarities in indications, design, materials, and comparative testing to listed predicate devices.

    The request asks for details typically associated with the validation of an AI/ML medical device, which include acceptance criteria, study design parameters (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods), and comparative effectiveness studies. None of these details are present in the provided text, as this device is a physical, bioabsorbable meniscal fixation device, not an AI/ML algorithm.

    Therefore, I cannot fulfill the request as the necessary information (acceptance criteria, study details for AI/ML validation) is not available in the given document.

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