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510(k) Data Aggregation

    K Number
    K181268
    Device Name
    PROLENE (Polypropylene) 3D Patch
    Manufacturer
    Ethicon, Inc.
    Date Cleared
    2018-07-26

    (73 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K010722
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The PROLENE™ 3D Patch is indicated for the repair of groin hernia defects that require a reinforcing material to obtain the desired surgical result.

    Device Description

    PROLENE™ 3D Patch is a device comprised of nonabsorbable (polypropylene) components. The polymer of the polypropylene filaments is identical to the material used in PROLENETM Suture. It consists of a flat mesh onlay patch secured to a formed expandable diamond-shaped mesh patch component. The expandable patch portion of the device is a hollow diamond-shaped component that is deployed through the use of an integrated, looped, polyester thread.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) summary for a medical device (PROLENE™ 3D Patch) seeking FDA clearance. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study design with acceptance criteria and device performance results as you've requested.

    The text does not include information about:

    • Acceptance criteria for device performance
    • A study comparing the device against these criteria
    • Sample sizes for test or training sets
    • Data provenance
    • Number or qualifications of experts
    • Adjudication methods
    • MRMC comparative effectiveness studies
    • Standalone algorithm performance
    • Type of ground truth used

    The core message of this document is that the PROLENE™ 3D Patch is identical to a previously cleared device (PROLENE™ (Polypropylene) 3D Patch, K010722) in terms of its technological characteristics, materials, construction, manufacturing, and sterilization. The only differences mentioned are revisions to the labeling (Instructions for Use) for clarity, to address regulatory expectations, and to add a new contraindication. The indication statement was also modified for clarity but does not introduce new indications or expand the patient population.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance based on the provided text, as this information is not present in the document.

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