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510(k) Data Aggregation

    K Number
    K080691
    Date Cleared
    2008-04-16

    (36 days)

    Product Code
    Regulation Number
    878.3300
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Atrium C-QUR Edge™ Mesh V-Patch is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a U.S. FDA 510(k) clearance letter for the Atrium C-QUR Edge™ Mesh V-Patch. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

    This type of regulatory document confirms that the FDA has reviewed the manufacturer's submission and determined that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed. It does not typically include detailed study results or performance metrics in the way you've described for AI/algorithm-based devices.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes used for test sets or data provenance.
    3. Number of experts or their qualifications.
    4. Adjudication method.
    5. MRMC comparative effectiveness study results or effect sizes.
    6. Standalone performance details.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    These details would typically be found in the 510(k) summary submitted by the manufacturer to the FDA, or in scientific publications related to the device, but not in the clearance letter itself.

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