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510(k) Data Aggregation

    K Number
    K172922
    Device Name
    MMPC-4127F1
    Manufacturer
    Barco N.V.
    Date Cleared
    2017-12-21

    (87 days)

    Product Code
    PZZ
    Regulation Number
    864.3700
    Type
    Traditional
    Panel
    Pathology (PA)
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MMPC-4127F1

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

    The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

    Device Description

    The MMPC-4127F1, also marketed as the PP27QHD, is a stabilized, color-calibrated display system designed to review and interpret digital images of surgical pathology slides.

    The display is equipped with a 27-inch color LCD panel with a fine pixel pitch that can be calibrated to the sRGB gamut.

    Accessories:

    • QAWeb quality assurance software
    • DisplayPort cable
    • USB cable
    • AC power cord cables
    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device, the Barco MMPC-4127F1 (PP27QHD) display, which is intended for in vitro diagnostic use to display digital images of histopathology slides. The submission aims to demonstrate substantial equivalence to a predicate device.

    The study presented is not for an AI/algorithm-only device, but for a display system. Therefore, many of the requested fields related to AI/algorithm performance (e.g., effect size, standalone performance, training set details, adjudication methods, multi-reader multi-case studies) are not applicable to this type of device. The acceptance criteria and performance testing focus on the display's technical characteristics and visual performance as they compare to the predicate device.

    Here's an analysis based on the provided document:

    1. A table of acceptance criteria and the reported device performance

    The document doesn't explicitly state "acceptance criteria" in a pass/fail quantifiable manner for each parameter, but rather compares the new device's specifications directly to the predicate device's specifications. The implicit acceptance criterion is that the new device's performance should be similar to or better than the predicate device without introducing new issues of safety or performance. The "reported device performance" is essentially the listed "New Device MMPC-4127F1 (PP27QHD)" specifications.

    ParameterNew Device MMPC-4127F1 (PP27QHD)Predicate Device MMPC-4127 (PP27QHDCR)Implicit Acceptance Criteria (based on comparison)
    Display Optical Performance
    Display technologyIPS LCDIPS LCDSame
    Native Resolution2560 x14402560 x1440Same
    Display LUT≥ 10 bit / sub-pixel≥ 10 bit / sub-pixelSame or equivalent
    Pixel Pitch (Horizontal) (mm)0.23310.2331Same
    Pixel pitch (Vertical) (mm)0.23310.2331Same
    Active screen (Diagonal) (mm / inch)685.8 / 27.0685.8 / 27.0Same
    Active screen (Width) (mm)596.74596.74Same
    Active screen (Height) (mm)335.66335.66Same
    Contrast Ratio - (typical)1000:11000:1Same or equivalent
    Luminance stabilization+2% / -2% front sensor+2% / -2% backlight sensorSimilar (different sensor type, but same stability range)
    Maximum Luminance (typical) (cd/m²)500500Same or equivalent
    DICOM Calibrated Luminance (Typical) (cd/m²)350350Same or equivalent
    Luminance non-uniformity (per DIN6868-157), diagnostic room class
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