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510(k) Data Aggregation

    K Number
    K090858
    Device Name
    PARIETEX MONOFILAMENT POLYESTER MESH
    Manufacturer
    SOFRADIM PRODUCTION
    Date Cleared
    2009-05-06

    (37 days)

    Product Code
    FTL
    Regulation Number
    878.3300
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K081126
    Predicate For
    K101519,K131969,K142908
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Parietex™ Monofilament Polyester Mesh is indicated for inguinal and ventral hernia repair.

    Device Description

    PARIETEX™ - Monofilament Polyester Mesh is made out of a non-absorbable bi-dimensional monofilament polyester knitting and is available in rectangular shape.

    AI/ML Overview

    This document is a 510(k) summary for a medical device called PARIETEX™ - Monofilament Polyester Mesh. It describes the device and its intended use, but it does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or AI performance.

    The "Performance Data" section states: "Bench testing has been conducted to evaluate the performance characteristics of PARIETEX™ - Monofilament Polyester Mesh. Testing has shown that the PARIETEX™ - Monofilament Polyester Mesh is similar in performance characteristics to the predicate MERSILENE™."

    This indicates a comparison was made to a predicate device, but it's focused on the material's performance characteristics through bench testing, not a study evaluating diagnostic accuracy or a specific set of acceptance criteria for an AI/algorithm-driven device.

    Therefore, the requested information for an AI/algorithm-focused study cannot be extracted from this document.

    Based on the provided document, the following cannot be answered:

    1. A table of acceptance criteria and the reported device performance: The document only mentions bench testing showing similarity in performance characteristics to a predicate device, but no specific quantitative acceptance criteria or reported values are given.
    2. Sample size used for the test set and the data provenance: Not applicable as there is no study described that involves a "test set" in the context of an algorithm.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    4. Adjudication method for the test set: Not applicable.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this document pertains to a surgical mesh, not a diagnostic imaging or AI device.
    6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
    7. The type of ground truth used: Not applicable.
    8. The sample size for the training set: Not applicable as there is no mention of a training set for an algorithm.
    9. How the ground truth for the training set was established: Not applicable.
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