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510(k) Data Aggregation

    K Number
    K053158
    Device Name
    OPTILENE MESH LP
    Manufacturer
    AESCULAP, INC.
    Date Cleared
    2006-01-18

    (65 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K962530,K001122
    Why did this record match?
    Device Name :

    OPTILENE MESH LP

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

    Optilene Mesh LP is indicated for hernioplasty and repair of other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

    Device Description

    Optilene Mesh LP is a synthetic implantable sheet for the reinforcement of connective tissue structures. It consists of monofilament polypropylene, which is knitted into a dimensionally stable, thin, and flexible net that is cut into various sizes and shapes.

    AI/ML Overview

    The provided document is a 510(k) summary for the Optilene Mesh LP surgical mesh. It declares substantial equivalence to existing predicate devices but does not contain information about acceptance criteria, performance studies, or details regarding the development and validation of an AI-powered device.

    Therefore, I cannot extract the requested information to fill in the table and answer the questions. The document describes a traditional surgical mesh, not an AI/ML device.

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