(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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December 21, 2017
Barco N.V. Lieven De Wandel Regulatory Officer 35 President Kennedypark 8500 Kortrijk, Belgium
Re: K172922
Trade/Device Name: MMPC-4127F1 (PP27QHD) Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: PZZ Dated: September 22, 2017 Received: September 25, 2017
Dear Mr. De Wandel:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Reena Philip -S
Reena Philip, Ph.D. Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172922
Device Name MMPC-4127F1
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary (in accordance with 21 CFR 807.92) | |
|---|---|
| 1. Company | Barco N.V.Healthcare Division35 President Kennedypark8500 KortrijkBELGIUM |
| 2. Contactperson | Lieven De WandelRegulatory Affairs Officer |
| 3. Date ofsubmission | September 22 2017 |
| 4. Deviceinformation | Trade name/model: MMPC-4127F1Common name: MMPC-4127F1Classification name: Whole Slide Imaging SystemClassification code: PSYRegulation number: 864.3700 |
| 5. Predicatedevice | MMPC-4127 (PP27QHDCR), display component ofPhilips IntelliSite Pathology Solution, cleared under DeNovo no. DEN160056 |
| 6. Devicedescription | The MMPC-4127F1, also marketed as the PP27QHD, is a stabilized, color-calibrateddisplay system designed to review and interpret digital images of surgical pathologyslides.The display is equipped with a 27-inch color LCD panel with a fine pixel pitch that can becalibrated to the sRGB gamut.Accessories:- QAWeb quality assurance software- DisplayPort cable- USB cable- AC power cord cables |
| 7. Intended Useof the Device | The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use todisplay digital images of histopathology slides acquired from IVD-labeled whole-slideimaging scanners that have been validated for use with this device, for review andinterpretation by pathologists. The display is not intended for use with digital images fromfrozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE)hematopathology specimens. |
Image /page/3/Picture/2 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. To the right of the "O" is a symbol that looks like a circle with a horizontal line through the middle, and two smaller circles on either side of the line.
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| 8. Comparisonof technologicalcharacteristics | Parameter | New DeviceMMPC-4127F1(PP27QHD) | Predicate DeviceMMPC-4127(PP27QHDCR),Displaycomponent ofPhilips IntelliSitePathology Solution |
|---|---|---|---|
| Display Optical Performance | |||
| Display technology | IPS LCD | IPS LCD | |
| Native Resolution | 2560 x1440 | 2560 x1440 | |
| Display LUT | ≥ 10 bit / sub-pixel | ≥ 10 bit / sub-pixel | |
| Pixel Pitch (Horizontal) (mm) | 0.2331 | 0.2331 | |
| Pixel pitch (Verical) (mm) | 0.2331 | 0.2331 | |
| Active screen (Diagonal) (mm / inch) | 685.8 / 27.0 | 685.8 / 27.0 | |
| Active screen (Width) (mm) | 596.74 | 596.74 | |
| Active screen (Height) (mm) | 335.66 | 335.66 | |
| Contrast Ratio - (typical) | 1000:1 | 1000:1 | |
| Luminance stabilization | +2% / -2%front sensor | +2% / -2% backlightsensor | |
| Maximum Luminance (typical) (cd/m²) | 500 | 500 | |
| DICOM Calibrated Luminance (Typical)(cd/m²) | 350 | 350 | |
| Luminance non-uniformity (per DIN6868-157), diagnostic room class | <25% on 9 points,10%/80% luminance | <25% on 9 points,10%/80% luminance | |
| Response Time (typical) (ms) | 12 | 12 | |
| Response Time (max) (ms) | 24 | 24 | |
| Calibration Performance | |||
| Supported color spaces | sRGB, DICOM,native | sRGB | |
| Average dE2000 deviation from sRGB | <2 on 6x6x6 grid | <2 on 6x6x6 grid | |
| Maximum dE2000 deviation from sRGB | <5 on 6x6x6 grid | <5 on 6x6x6 grid | |
| White point chromaticity stabilization | +/-0.01 u'v' | +/-0.01 u'v' | |
| Gray tracking (per IEC 62563) | +/-0.01 u'v' | +/-0.01 u'v' | |
| Grayscale transfer function deviation | <10% on 18 points | <10% on 18 points | |
| Calibration Software | MediCal QAWeb | Nucleus Software | |
| Environmental Specifications | |||
| Operational Temperature (min/max) (°C) | 10 / 40 | 10 / 40 | |
| Within specification temperature(min/max) (°C) | 10 / 35 | 10 / 35 | |
| Power Consumption (@ 100-240VACtypical) (W) | 120 | 85 | |
| 9. Performancetesting | The bench tests mentioned below were performed to validate the device characteristicsthat differ from the predicate device: | ||
| Spatial resolution | |||
| Pixel defects | |||
| Artifacts | |||
| Temporal response | |||
| Maximum and minimum luminance | |||
| Grayscale |
BARCO
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| Intrinsic bit-depth of panel | |
|---|---|
| True output bit depth by performing visual test with gradient test pattern | |
| Mapping of image values (DDL) to luminance (cd/m²) | |
| Luminance uniformity and Mura | |
| Stability of luminance and chromaticity | |
| Stability of calibrated luminance over temperature | |
| Stability of calibrated luminance over time | |
| Specular and diffuse coefficients | |
| Gray Tracking | |
| Color scale | |
| Color gamut | |
| Angular dependency of the luminance | |
| Noise | |
| RMS (image variance) for multiple video levels | |
| NPS (Noise Power Spectrum) | |
| Veiling glare | |
| The tests showed that the device has similar characteristics compared to the predicatedevice and did not reveal new issues of safety and performance. | |
| Animal testing has not been performed. | |
| 10. Conclusion | The MMPC-4127F1 display was found to be substantially equivalent to the predicatedevice, due to the following reasons: |
| a) | Device and predicate device have the same intended use |
| b) | The technological characteristics differences from the predicate device do notaffect safety or effectiveness |
| c) | Bench testing showed that the device has similar characteristics compared to thepredicate device and did not reveal new issues of safety and performance. |
Image /page/5/Picture/2 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. The "O" in "BARCO" has a small extension on the upper right side, resembling a stylized electronic component.
§ 864.3700 Whole slide imaging system.
(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.