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510(k) Data Aggregation

    K Number
    K992960
    Device Name
    ADVANTA GRAFT (>6MM)
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    1999-10-01

    (29 days)

    Product Code
    DSY
    Regulation Number
    870.3450
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    K231972
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Atrium (Wrapped) Advanta™ Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a letter from the FDA to Atrium Medical Corporation regarding the 510(k) clearance of the Atrium Advanta™ Graft. This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device and states the indications for use.

    It does not contain information about:

    1. Acceptance criteria and reported device performance: The letter does not detail the specific performance metrics or thresholds the device needed to meet.
    2. Sample size and data provenance for a test set.
    3. Number and qualifications of experts for ground truth establishment.
    4. Adjudication method.
    5. Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
    6. Standalone algorithm performance.
    7. Type of ground truth used (pathology, outcomes data, etc.) for testing.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is a regulatory approval letter, not a detailed study report or clinical trial summary.

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