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510(k) Data Aggregation

    K Number
    K973067
    Device Name
    DRTS REMOTE CONTROL DRAPE
    Manufacturer
    MINRAD, INC.
    Date Cleared
    1997-10-16

    (59 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 DRTS™ Remote Control Drape is intended to provide a sealed, sterile, see through cover for the hand held, DRTS remote control, or any similar sized instrument, when its use is required in the sterile field. Secondarily, the Remote Control Drape will protect the contained instrument from damage or contamination caused by unintended contact with body fluids, surgical solutions or other contaminants in the surgical field.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents [0, 1] are a 510(k) clearance letter from the FDA for a device named "DRST™ Remote Control Drape" and its indications for use. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment for an AI/ML device.

    The DRST™ Remote Control Drape is a physical medical device (a sterile cover for a remote control), not an AI/ML software device. Therefore, the questions related to AI/ML device performance, training sets, test sets, ground truth, and expert evaluation are not applicable to this submission.

    Thus, I cannot provide the requested information based on the given input documents.

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