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510(k) Data Aggregation
(150 days)
The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed digital pathology image viewing software that have been validated for use with this device. It is an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using the MDPC-8127. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
The Barco MDPC-8127 is a medical, color-calibrated display, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners and digital pathology image viewing software that have been validated for use with the display.
The use of the MDPC-8127 display with scanners and viewing software is determined by using verified test methods to establish the display's capability to meet or exceed the performance specifications and the intended color space specified by the IVD-labeled whole-slide imaging scanners and digital pathology image viewing software.
The display uses built-in techniques and technology to ensure constant accuracy over time.
The MDPC-8127 consists of an 8 mega-pixel, 27-inch color LCD-panel with internal electronics platform. It is calibrated to defined color spaces for whole-slide imaging and is compatible with digital pathology viewinq software that utilizes defined color spaces to ensure images are displayed in intended colors.
The provided text describes the Barco MDPC-8127, a medical display intended for in vitro diagnostic use to display digital images of histopathology slides. The document details the device's technical specifications and performance testing to demonstrate substantial equivalence to a predicate device, the MMPC-4227F1 (PP27QHD).
Here's an analysis of the acceptance criteria and study proving the device meets them, based only on the provided text:
Key Takeaway from the Document: The study primarily focuses on non-clinical bench testing to demonstrate the MDPC-8127's technical characteristics and performance are equivalent to or better than a predicate device. It is not a clinical study involving human readers and a comparative effectiveness assessment with AI assistance. The display itself is a tool for pathologists, not an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a table comparing the performance of the MDPC-8127 (proposed device) with its predicate device (MMPC-4227F1). While not explicitly labeled as "acceptance criteria," these are the parameters against which the device's performance was evaluated for substantial equivalence. The "Results" column for MDPC-8127 represents the reported device performance.
| Test | MDPC-8127 Reported Performance | Predicate Device Performance (Reference) |
|---|---|---|
| User controls | Luminance target, maximum: 450 cd/m²; Display function: sRGB; White point: 6500K; Color space: sRGB; 10 minutes of warm-up time | Luminance target, maximum: 350 cd/m²; Display function: sRGB; White point: 6500K; Color space: sRGB; 10 minutes of warm-up time |
| Spatial resolution | Both horizontal and vertical MTFs are greater than 85% at Nyquist frequency | Both horizontal and vertical MTFs are greater than 75% at Nyquist frequency |
| Pixel defects | Total number of bright and dark pixels 1000:1 | Maximum: 550 cd/m²; Minimum: 0.3 cd/m²; Calibrated target: 350 cd/m²; Contrast ratio: 1000:1 |
| Grayscale | Maximum error calculated = 1.4% | Maximum error calculated = 2.1% |
| Luminance uniformity and Mura |
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