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510(k) Data Aggregation

    K Number
    K041528
    Device Name
    MODIFICATION TO EPTFE GRAFT
    Manufacturer
    VASCUTEK LTD.
    Date Cleared
    2004-09-14

    (98 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MODIFICATION TO EPTFE GRAFT

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

    SUBCUTANEOUS OF CREATION CONDUITS FOR BLOOD ARTERIOVENOUS ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.

    Device Description

    VASCUTEK ePTFE WRAPPED ePTFE VASCULAR PROSTHESES

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) K041528 document does not contain the information required to answer your request.

    The document is a letter from the FDA to Vascutek Ltd. acknowledging the review of their 510(k) premarket notification for the "Vascutek ePTFE Wrapped ePTFE Vascular Prosthesis." It states that the device is substantially equivalent to legally marketed predicate devices.

    Specifically, the document does not include:

    1. A table of acceptance criteria and reported device performance.
    2. Details about sample sizes for test sets, data provenance, or training sets.
    3. Information on the number or qualifications of experts used to establish ground truth.
    4. Adjudication methods.
    5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
    6. Results of a standalone algorithm performance study.
    7. The type of ground truth used.
    8. How ground truth for a training set was established.

    This document is primarily an approval letter and an "Indications for Use" statement, not a detailed study report. To find the information you're looking for, you would typically need to consult the actual 510(k) submission summary or associated clinical/technical reports, which are not provided in this excerpt.

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