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    K Number
    K972412
    Device Name
    PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH
    Manufacturer
    ETHICON, INC.
    Date Cleared
    1997-09-10

    (76 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General and Plastic Surgery (SU)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH

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

    The PROLENE Polypropylene Mesh Hernia Device is intended to be used for the repair of indirect and direct inguinal hernia defects.
    The PROLENE Mesh Hernia Device is indicated for the repair of inguinal hernia defects, both indirect and direct.

    Device Description

    The PROLENE Polypropylene Mesh Hernia Device is a sterile, pre-shaped, three dimensional device constructed of an onlay patch connected by a mesh cylinder to a circular underlay patch. The material is undyed PROLENE* polypropylene mesh constructed of knitted non-absorbable polypropylene filaments identical to that used in PROLENE* polypropylene nonabsorbable surgical sutures, U.S.P. (ETHICON, INC.). This material, when used as a suture, has been reported to be nonreactive and to retain its strength indefinitely in clinical use.

    AI/ML Overview

    The device, PROLENE Polypropylene Mesh Hernia Device, is intended for the repair of indirect and direct inguinal hernia defects.

    Here's an analysis of its acceptance criteria and the supporting study:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Effective in repairing inguinal herniasDemonstrated effectiveness in repairing inguinal hernias in a preclinical study.
    Maintains its position in the inguinal canal without the aid of suturesDemonstrated maintenance of position in the inguinal canal without sutures in a preclinical study.
    Permits postoperative tissue ingrowthDemonstrated in a preclinical study.
    Demonstrates functionalityDemonstrated in a preclinical study.
    Comparable technological characteristics to predicate device (BARD® Marlex® Mesh PerFix® Plug)The device is also a pre-shaped, three-dimensional device constructed of knitted polypropylene monofilaments, similar to the predicate.
    Nonreactive materialMaterial (PROLENE polypropylene) is reported to be nonreactive when used as a suture.
    Retains strength indefinitely in clinical useMaterial (PROLENE polypropylene) is reported to retain strength indefinitely in clinical use when used as a suture.

    2. Sample Size Used for the Test Set and Data Provenance

    The document states that a "preclinical study" was conducted. However, it does not specify the sample size used for this study (e.g., number of animals or specific experimental units). It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

    This information is not provided in the document. The study was a preclinical one, and it's not clear if "experts" in the human clinical sense were involved in establishing ground truth for the animal model.

    4. Adjudication Method for the Test Set

    This information is not provided in the document.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a preclinical study, not a clinical study involving human readers.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

    This is not applicable as the device is a physical surgical mesh and not an AI algorithm.

    7. The Type of Ground Truth Used

    The ground truth was likely established through observational data and assessment of biological outcomes in the preclinical study. This would include direct observation of hernia repair, assessment of device position, and histological examination to confirm tissue ingrowth and functionality within the animal model.

    8. The Sample Size for the Training Set

    This information is not applicable as the device is not an AI/ML algorithm that requires a training set. The "training" for this device would be its design and manufacturing process, and performance verification would come from the preclinical study.

    9. How the Ground Truth for the Training Set Was Established

    This information is not applicable as the device is not an AI/ML algorithm.

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