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510(k) Data Aggregation

    K Number
    K070380
    Device Name
    PORTACLAMP FLEX
    Manufacturer
    CARDIO LIFE RESEARCH, S.A.
    Date Cleared
    2007-06-08

    (120 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Portaclamp® Flex is indicated to clamp the aorta during minimally invasive cardiac surgery implying the usage of an extra-corporeal circulation.

    Device Description

    The Portaclamp® Flex is an aortic clamping device composed of a detachable, reusable handle and a single-use, disposable clamp. It is designed to be used through a standard thoracic port to clamp the aorta during minimally invasive cardiac bypass procedures. The Portaclamp Flex consists of a flexible guide wire, two jaws that are passed over the guide wire and positioned on each side of the aorta, and a mandrel that is slid along the length of the jaws to compress the jaws and clamp the aorta.

    AI/ML Overview

    The provided text is a 510(k) summary for the Portaclamp® Flex, a vascular clamp. However, it does not contain information on acceptance criteria, a specific study proving device performance against those criteria, or details regarding ground truth, expert opinions, or statistical analysis typically associated with AI/algorithm performance studies.

    The document focuses on demonstrating substantial equivalence to predicate devices for mechanical characteristics and intended use, rather than the performance of an AI or algorithm.

    Therefore, I cannot provide details on the following based on the provided text:

    • A table of acceptance criteria and reported device performance (for an AI/algorithm)
    • Sample sizes used for test/training sets or data provenance
    • Number of experts or their qualifications
    • Adjudication method
    • MRMC comparative effectiveness study
    • Standalone algorithm performance
    • Type of ground truth used
    • How ground truth was established

    The current document describes a traditional medical device (a vascular clamp), not an AI/algorithm-based device, and therefore the requested information regarding AI/algorithm performance studies is not present.

    If you have a different document describing an AI/algorithm-based medical device, please provide that, and I can then attempt to extract the requested information.

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