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510(k) Data Aggregation

    K Number
    K070680
    Manufacturer
    Date Cleared
    2007-04-05

    (24 days)

    Product Code
    Regulation Number
    870.2855
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks.

    Device Description

    Not Found

    AI/ML Overview

    The provided text describes the Indications for Use for the CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System. It states that the device is intended for measuring intrasac pressure during endovascular abdominal aortic aneurysm (AAA) repair and may be used as an adjunctive tool in the detection of intraoperative endoleaks.

    However, the provided text does not contain any information regarding the acceptance criteria, the study that proves the device meets those criteria, or any of the detailed points requested in your prompt.

    Therefore, I cannot fulfill your request for:

    1. A table of acceptance criteria and the reported device performance
    2. Sample sizes or data provenance
    3. Number and qualifications of experts
    4. Adjudication method
    5. MRMC study details or effect size
    6. Standalone performance information
    7. Type of ground truth used
    8. Training set sample size
    9. Method for establishing training set ground truth

    To answer your request, I would need a different document, such as a 510(k) summary, clinical study report, or a detailed technical specification that describes the validation and performance testing of the CardioMEMS EndoSure™ s2 14F Wireless AAA Pressure Measurement System.

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