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510(k) Data Aggregation
(87 days)
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.
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
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.
| Parameter | New Device MMPC-4127F1 (PP27QHD) | Predicate Device MMPC-4127 (PP27QHDCR) | Implicit Acceptance Criteria (based on comparison) |
|---|---|---|---|
| Display Optical Performance | |||
| Display technology | IPS LCD | IPS LCD | Same |
| Native Resolution | 2560 x1440 | 2560 x1440 | Same |
| Display LUT | ≥ 10 bit / sub-pixel | ≥ 10 bit / sub-pixel | Same or equivalent |
| Pixel Pitch (Horizontal) (mm) | 0.2331 | 0.2331 | Same |
| Pixel pitch (Vertical) (mm) | 0.2331 | 0.2331 | Same |
| Active screen (Diagonal) (mm / inch) | 685.8 / 27.0 | 685.8 / 27.0 | Same |
| Active screen (Width) (mm) | 596.74 | 596.74 | Same |
| Active screen (Height) (mm) | 335.66 | 335.66 | Same |
| Contrast Ratio - (typical) | 1000:1 | 1000:1 | Same or equivalent |
| Luminance stabilization | +2% / -2% front sensor | +2% / -2% backlight sensor | Similar (different sensor type, but same stability range) |
| Maximum Luminance (typical) (cd/m²) | 500 | 500 | Same or equivalent |
| DICOM Calibrated Luminance (Typical) (cd/m²) | 350 | 350 | Same or equivalent |
| Luminance non-uniformity (per DIN6868-157), diagnostic room class | <25% on 9 points, 10%/80% luminance | <25% on 9 points, 10%/80% luminance | Same or equivalent |
| Response Time (typical) (ms) | 12 | 12 | Same or equivalent |
| Response Time (max) (ms) | 24 | 24 | Same or equivalent |
| Calibration Performance | |||
| Supported color spaces | sRGB, DICOM, native | sRGB | New device supports more color spaces without affecting safety/effectiveness |
| Average dE2000 deviation from sRGB | <2 on 6x6x6 grid | <2 on 6x6x6 grid | Same or equivalent |
| Maximum dE2000 deviation from sRGB | <5 on 6x6x6 grid | <5 on 6x6x6 grid | Same or equivalent |
| White point chromaticity stabilization | +/-0.01 u'v' | +/-0.01 u'v' | Same or equivalent |
| Gray tracking (per IEC 62563) | +/-0.01 u'v' | +/-0.01 u'v' | Same or equivalent |
| Grayscale transfer function deviation | <10% on 18 points | <10% on 18 points | Same or equivalent |
| Calibration Software | MediCal QAWeb | Nucleus Software | Different software, but performance judged similar |
| Environmental Specifications | |||
| Operational Temperature (min/max) (°C) | 10 / 40 | 10 / 40 | Same |
| Within specification temperature (min/max) (°C) | 10 / 35 | 10 / 35 | Same |
| Power Consumption (@ 100-240VAC typical) (W) | 120 | 85 | New device has higher power consumption, deemed not to affect safety/effectiveness |
The conclusion states: "The tests showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and performance." This broadly represents the "acceptance criteria" and "reported device performance" for the studied parameters.
2. Sample size used for the test set and the data provenance
This is a technical device (display) study, not a clinical study on diagnostic accuracy with patient data. The "test set" refers to the device itself and its components undergoing various bench tests. There is no mention of "sample size" in terms of number of patient cases or images, as the testing focuses on the display's physical and technical performance.
- Test Set: The device itself (Barco MMPC-4127F1).
- Data Provenance: The tests are bench tests performed on the display device, not on clinical data. The submitter is Barco N.V. based in Kortrijk, Belgium.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth for a display device's performance is established through objective measurements using specialized equipment and established standards (e.g., DIN6868-157, IEC 62563), not through expert consensus or clinical interpretation.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation of images or adjudication of discrepant readings.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a display device, not an AI or algorithm. There were no human reader studies described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display device, not an AI or algorithm.
7. The type of ground truth used
The "ground truth" for this type of device effectively refers to the measurement standards and expected performance specifications for a medical display. These are objective measurements of optical and electrical properties, such as luminance, contrast, resolution, color accuracy, and temperature stability, validated against industry standards. It is not expert consensus, pathology, or outcomes data related to patient diagnosis.
8. The sample size for the training set
Not applicable. This is a display device, not an AI or algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/algorithm, this question is not relevant.
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