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510(k) Data Aggregation

    K Number
    K034068
    Device Name
    CONTOUR SE MICROSPHERES
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Date Cleared
    2004-03-26

    (86 days)

    Product Code
    KRD
    Regulation Number
    870.3300
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K030966,K022427,K032707,K032542
    Predicate For
    K061790,K073417,K081768
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Contour SE™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).

    Device Description

    Contour SET™ Microspheres may be used for the embolization of hypervascular tumors, including leiomyoma uteri, and arteriovenous malformations (AVMs).

    AI/ML Overview

    The provided text is a summary of safety and effectiveness for a medical device (Contour SET™ Microspheres) and a letter from the FDA regarding its 510(k) premarket notification. This document outlines the general provisions, intended use, and substantial equivalence to predicate devices for the Contour SET™ Microspheres.

    However, the document does not contain information about acceptance criteria, specific device performance metrics, detailed study designs (sample sizes for test/training sets, data provenance, expert qualifications for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used, in the context that would be expected for a typical AI/ML device study.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details as requested. The document focuses on regulatory approval based on substantial equivalence to existing devices and biocompatibility, not on a performance study against predefined acceptance criteria for a new AI/ML-driven device.

    No information is available in the provided text to fulfill the request for a table of acceptance criteria and reported device performance, or the detailed study information regarding sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

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