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510(k) Data Aggregation

    K Number
    K041269
    Device Name
    ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
    Manufacturer
    ATRIUM MEDICAL CORP.
    Date Cleared
    2004-09-14

    (125 days)

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

    ATRIUM MEDICAL CORPORATION ICAST COVERED STENT

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

    The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Atrium iCAST Covered Stent, not a study report or clinical trial document. Therefore, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, expert qualifications, or ground truth establishment.

    A 510(k) clearance letter focuses on establishing substantial equivalence to a predicate device, and while it confirms the device is safe and effective for its indicated use, it does not typically include the specifics of a clinical study or performance data in the level of detail requested.

    Therefore, based solely on the provided text, I cannot answer the questions. The document does not contain information on:

    1. Acceptance criteria and reported device performance: This letter is a regulatory clearance, not a performance report.
    2. Sample size, data provenance: Not mentioned.
    3. Number/qualifications of experts, ground truth establishment: Not mentioned.
    4. Adjudication method: Not mentioned.
    5. MRMC comparative effectiveness study: Not mentioned and not typically part of a 510(k) summary for this type of device.
    6. Standalone performance study: Not mentioned.
    7. Type of ground truth: Not mentioned.
    8. Training set sample size: Not mentioned.
    9. Ground truth for training set: Not mentioned.

    To obtain this information, one would typically need to review the premarket notification (510(k) submission) itself, including any clinical data or bench testing summaries submitted by the manufacturer to the FDA.

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