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510(k) Data Aggregation

    K Number
    K973073
    Device Name
    DRTS IMAGE INTENSIFIER DRAPE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    1997-10-08

    (51 days)

    Product Code
    JAA
    Regulation Number
    892.1650
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MINRAD™ DRTS™ Image Intensifier Drape is intended to provide a closed, sterile cover for the Image Intensifier end of all presently marketed, mobile C-Arm X-ray machines.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA clearance letter for a medical device (MINRAD™ Inc.'s DRTS™ Image Intensifier Drape), and as such, it primarily focuses on regulatory approval rather than a detailed study report with performance metrics, acceptance criteria, or ground truth establishment.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set or data provenance.
    3. Number of experts used or their qualifications.
    4. Adjudication method.
    5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
    6. Information on a standalone performance study.
    7. The type of ground truth used.
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.
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