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510(k) Data Aggregation

    K Number
    K023811
    Device Name
    MODIFICATION TO VIABAHN ENDOPROSTHESIS
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Date Cleared
    2002-12-10

    (25 days)

    Product Code
    JCT
    Regulation Number
    878.3720
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO VIABAHN ENDOPROSTHESIS

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

    The GORE VIABAHN® Endoprosthesis is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

    Device Description

    The VIABAHN™ Endoprosthesis is a self-expanding implantable endoprosthesis that is compressed and secured on the distal end of a catheter delivery system. The catheter delivery system provides a means for implanting the endoprosthesis at a target location within the tracheobronchial tract. The endoprosthesis consists of a fluoropolymeric tube with a within the factor over its external surface. The catheter delivery system is configured with radiopaque markers and is designed for use with guidewires.

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot extract the specific details regarding acceptance criteria and the comprehensive study information you're requesting. The document is primarily a 510(k) premarket notification summary for the GORE VIABAHN™ Endoprosthesis, informing of its substantial equivalence to a predicate device and its intended use. It does not contain the detailed methodology and results of a study that would lay out acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop performance.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample sizes for test sets or data provenance.
    3. Number and qualifications of experts for ground truth.
    4. Adjudication method for the test set.
    5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
    6. Confirmation or details of a standalone performance study.
    7. The type of ground truth used.
    8. The sample size for the training set.
    9. How the ground truth for the training set was established.
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