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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 <= 5 with a minimum distance greater than 15 mm. | Total number of bright and dark pixels <= 3 within a circle of 10 mm diameter |
| Artifacts | < 0.65% | < 0.65% |
| Temporal response | The response time ranges from 3.1 ms to 6.2 ms with an average of 5.01 ms. | The response time is maximum 15 ms and typical 8 ms. |
| Maximum and minimum luminance | Maximum: 678.6 cd/m²; Minimum: 0.633 cd/m²; Calibrated target: 450 cd/m²; Contrast ratio: > 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 | <10% non-uniformity on 80% video level | 21% non-uniformity on 80% video level |
| Stability of luminance and chromaticity response | Deviation from target luminance (450 cd/m²): ± 0.44%; Variations for luminance and chromaticity: < 5% deviation | Deviation from target luminance (350 cd/m²): ± 0.2%; Variations for luminance and chromaticity: < 2% deviation |
| Bidirectional reflection distribution function | Specular reflection coefficient: 1.90%; Diffuse reflection coefficient: 2.87% | Specular reflection coefficient: 1.69%; Diffuse reflection coefficient: 2.21% |
| Gray tracking | ± 0.01 Δu'v'; White point at D65: ± 0.01 Δu'v' | ± 0.002 Δu'v'; White point at D65: ± 0.002 Δu'v' |
| Color scale | Average color error < 1 ΔE₀₀; Maximum color error < 3 ΔE₀₀ | Average color error < 2 ΔE₀₀; Maximum color error < 5 ΔE₀₀ |
| Color gamut volume | 2D color gamut wrt sRGB: 137.1%; 2D color gamut overlapped with sRGB: 99.6% | 2D color gamut wrt sRGB: 99.4%; 2D color gamut overlapped with sRGB: 98.4% |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing of the display device itself. Therefore, concepts like "test set," "sample size," and "data provenance" in the context of images or patient data are not applicable to the performance study described. The performance tests were conducted on the physical display unit.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The study is a non-clinical bench test of a display's physical and technical performance parameters (e.g., luminance, resolution, color accuracy), not a study involving the interpretation of medical images by experts to establish ground truth for a diagnostic algorithm.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench test of hardware performance, not an expert-based image interpretation study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No MRMC comparative effectiveness study was mentioned. The device is a display, not an AI algorithm. The performance testing described is focused on the technical specifications of the display itself, demonstrating its equivalence or superiority to a predicate display, not on how human readers perform with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study was done
Not applicable. The MDPC-8127 is a display device, not a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations (e.g., luminance, color accuracy, resolution) would be based on established measurement standards and calibrated equipment (e.g., photometers, colorimeters) as outlined in the test methods (e.g., IDMS v1.03b, AAPM TG-18). It is not "expert consensus," "pathology," or "outcomes data" in the medical diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device. The concept of a "training set" is relevant for machine learning algorithms, which is not what this approval is about.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as above.
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