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510(k) Data Aggregation

    K Number
    K981856
    Device Name
    MAGNA-CAM (MR ENDOSCOPIC CAMERA) AND MAGNA-PIX ( MR COLOR VIDEO MONITOR)
    Manufacturer
    GREATBATCH SCIENTIFIC
    Date Cleared
    1998-07-29

    (63 days)

    Product Code
    FET
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The MR Endoscopic Video System is intended to digitally generate and display an image captured from a rigid or flexible endoscope during a minimally invasive interventional MR surgical procedure.

    Device Description

    The MR Endoscopic Video System consists of a color camera signal processor (PAL or NTSC), camera head, color video monitor and all associated cables. The camera is powered by a 19 volt (PAL) or 15 volt (NTSC) battery pack. The video monitor is powered by a 110 volt AC to 12.5 volt DC medical-grade power supply attached to the end of a 20 foot shielded cable. The camera head attached to endoscopes by a non-conductive snap-lock coupling. The camera is connected to the video monitor via a cable. The endoscopic image can then be displayed to a remotely located video monitor.

    AI/ML Overview

    The provided document is a 510(k) Premarket Notification for the "MR Endoscopic Video System" from Greatbatch Scientific, dated July 29, 1998. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics, electrical safety, and MR safety.

    This document does not contain information regarding clinical performance studies with acceptance criteria, human reader performance, or ground truth establishment typically found in submissions for AI/ML-powered medical devices. The device described is an endoscopic video system, which is a display technology, not an AI diagnostic or assistance algorithm.

    Therefore, I cannot provide the requested information. The document only states:

    Acceptance Criteria/Performance (Implicit):
    The device was tested for Electrical Safety and Performance Data (Electromagnetic Compatibility) and MR Safety. It was found to be "acceptable in an interventional MR environment." This implies that the acceptance criteria were met for these safety and basic performance aspects, likely against established electrical safety and MR compatibility standards of the time.

    Specific Study Details Not Available:
    The document does not detail specific acceptance criteria for image quality, diagnostic accuracy, precision, or other performance metrics that would be relevant for an AI/ML-driven device. There is no mention of:

    • Reported device performance values (e.g., sensitivity, specificity).
    • Sample sizes for test sets, data provenance.
    • Number/qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC comparative effectiveness studies (AI vs. without AI).
    • Standalone algorithm performance.
    • Type of ground truth used (expert consensus, pathology, outcomes data).
    • Sample size for training set.
    • How ground truth for the training set was established.

    This information is absent because the device is a video system, not an AI/ML diagnostic tool.

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