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510(k) Data Aggregation

    K Number
    K052199
    Device Name
    21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
    Manufacturer
    TOTOKU ELECTRIC CO., LTD
    Date Cleared
    2005-09-22

    (41 days)

    Product Code
    LLZ
    Regulation Number
    892.2050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K050485
    Why did this record match?
    Reference Devices :

    K050485

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.

    Device Description

    21.3-inch Monochrome LCD monitor that supports DVI video signal and provides QXGA (1536 X 2048) resolution for both landscape and portrait display.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical display monitor (TOTOKU 21.3-inch Monochrome LCD Monitor MDL2115A). This type of device is a display for medical images, not an AI/ML algorithm or diagnostic software that performs analysis or makes decisions.

    Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) does not apply to this specific device.

    The 510(k) summary for a display monitor focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing technical specifications (e.g., resolution, display technology, intended use) and conformity to relevant standards (e.g., DICOM Part 14 for grayscale display function, IEC standards for safety). There's no clinical performance study involving diagnostic accuracy, sensitivity, or specificity as there would be for an AI-powered diagnostic tool.

    The summary states:

    • Intended Use: "21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography."
    • Substantial Equivalence: "MDL2115A (ME353i) (DV3MM-HB) (ME353iM) has almost the same characteristics as TOTOKU's predicate device MDL2110A (K050485) except for a LCD panel, an inverter and chassis."

    The "acceptance criteria" for such a device would typically relate to its technical performance matching or exceeding the predicate device and meeting relevant industry standards for medical displays. This would involve measurements of luminance, contrast, resolution, noise, and compliance with the DICOM Part 14 standard for grayscale display function, but not clinical performance metrics tied to patient outcomes or expert diagnoses.

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