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.

Device Description

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.

AI/ML Overview

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.

Summary

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April 15, 2021

Barco NV Lieven De Wandel Regulatory Affairs Officer President Kennedypark 35 Kortrijk, W-VL 8500 Belgium

Re: K203364

Trade/Device Name: MDPC-8127 Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: PZZ Dated: February 12, 2021 Received: February 22, 2021

Dear Lieven 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Soma Ghosh, Ph.D. Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203364

Device Name MDPC-8127

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

MDPC-8127

Company

Barco N.V. Healthcare Division 35 President Kennedypark 8500 Kortrijk BELGIUM

Contact person

Lieven De Wandel Requlatory Affairs Officer Tel: +32 (0)56 233459 lieven.dewandel@barco.com

Date of submission

February 12, 2021

Device information

Trade name/model:	MDPC-8127
Common name:	Digital Pathology Display
Classification name:	Digital Pathology Display
Classification code:	PZZ
Regulation number:	21 CFR §864.3700

Predicate device

MMPC-4227F1 (PP27QHD), Display used in Philips Intellisite Pathology Solution, referenced in 510(k) - K192259 (Philips Intellisite Pathology Solution)

Device description

The display uses built-in techniques and technology to ensure constant accuracy over time.

P 1 / 5

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The display is available with the following software accessories:

Intuitive Workflow Tools (When paired with a Barco MXRT display controller graphics card and driver ● software)

Test	Test Method	Results
		MDPC-8127	Predicate device
User controls	Out-of-the-box settings	Luminance target, maximum: 450 cd/m²Display function: sRGBWhite point: 6500KColor space: sRGB10 minutes of warm-up time	Luminance target, maximum:350 cd/m2Display function: sRGBWhite point: 6500KColor space: sRGB10 minutes of warm-up time
Spatialresolution	Roehrig, Hans, et al. "In-field evaluation of themodulation transfer functionof electronic displaydevices." Medical Imaging2004: Visualization, Image-Guided Procedures, andDisplay. Vol. 5367.International Society forOptics and Photonics, 2004	Both horizontal and verticalMTFs are greater than 85%at Nyquist frequency	Both horizontal and verticalMTFs are greater than 75% atNyquist frequency
Pixel defects	7.6 Defective Pixels, IDMSv1.03b	Total number of bright anddark pixels <= 5 with aminimum distance greaterthan 15 mm.	Total number of bright anddark pixels <= 3 within acircle of 10 mm. diameter
Artifacts	Image retention after 1 hour	< 0.65%	< 0.65%
Temporalresponse	10.2.3 Gray-to-GrayResponse Time, IDMSv1.03b	The response time rangesfrom 3.1 ms to 6.2 ms withan average of 5.01 ms.	The response time ismaximum 15 ms and typical8 ms.
Maximumandminimumluminance	5 FundamentalMeasurements, IDMSv1.03b	The maximum andminimum achievableluminance values are 678.6and 0.633 cd/m²,respectively.The calibrated luminancetarget is 450 cd/m².The contrast ratio is greaterthan 1000: 1.	The maximum and minimumachievable luminance valuesare 550 and 0.3 cd/m2,respectively.The calibrated luminancetarget is 350 cd/m2.The contrast ratio is 1000: 1.
Grayscale	Contrast response deviation,AAPM TG-18	Maximum error calculated =1.4%	Maximum error calculated =2.1%
Luminanceuniformityand Mura	8 Uniformity Measurements,IDMS v1.03b	<10% non-uniformity on80% video level	21% non-uniformity on 80%video level
Stability ofluminanceandchromaticityresponse	Luminance and chromaticitycharacteristics of the displaymeasured with temperatureand time	Deviation from targetluminance (450 cd/m²):$\pm$ 0.44%Variations for luminanceand chromaticity: < 5%deviation	Deviation from targetluminance (350 cd/m2):$\pm$ 0.2%Variations for luminance andchromaticity: < 2% deviation
Bidirectionalreflectiondistributionfunction	11. ReflectionMeasurements, IDMSv1.03b	Specular reflectioncoefficient: 1.90%Diffuse reflectioncoefficient: 2.87%	Specular reflectioncoefficient: 1.69%Diffuse reflection coefficient:2.21%
Graytracking	6.15 Gray-scale ColorChanges, IDMS v1.03b	$\pm$ 0.01 Δu'v'White point at D65: $\pm$0.01 Δu'v'	$\pm$ 0.002 Δu'v'White point at D65: $\pm$ 0.002Δu'v'
Color scale	6. Gray- and Color-ScaleMeasurement, IDMS v1.03b	Average color error < 1ΔE₀₀Maximum color error < 3ΔE₀₀	Average color error< 2 ΔE₀₀Maximum color error < 5ΔE₀₀
Color gamutvolume	5.18.1 Relative Gamut Area,IDMS v1.03b	2D color gamut wrt sRGB:137.1%2D color gamut overlappedwith sRGB: 99.6%	2D color gamut wrtsRGB: 99.4%2D color gamut overlappedwith sRGB: 98.4%

Table 1: Relevant performance specifications with verified test methods

P 2 / 5

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Intended Use

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 using IVD-labeled 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.

Table 2: Comparison of technological characteristics

Item	Proposed DeviceMDPC-8127	Predicate deviceMMPC-4227F1 (PP27QHD)
Screen technology	IPS	Same
Active screen size (diagonal)	684 mm (27")	Same
Dimensions (W x H x D)	651 x 482~582 x 238 mm	648.5 x 473~573 x 235 mm
Resolution	8MP (3840 x 2160 pixels)	3.6MP (2560 x1440 pixels)
Color bit depth (internal)	10 bit color	8 bit color
Calibrated luminance	450 cd/m²	350 cd/m²
Contrast ratio	1000: 1	1000: 1
Uniformity Technology	Color PPU	None
Color Calibration	sRGB and DICOM GSDF modes	sRGB and DICOM GSDF modes
Front sensor for stabilization andcalibration	Yes, I-Guard™	Front sensor

P 3 / 5

ENABLING BRIGHT OUTCOMES

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Performance testing

According to FDA Guidance document titled "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: April 20, 2016" (TPA Guidance), Chapter IV (A) (11), the below-mentioned tests were performed on the proposed device and the predicate device to verify that the technical characteristics and performance of the proposed display are equivalent to the predicate device:

Spatial Resolution ●
. Pixel defects
Artefacts
Temporal response .
. Max and Min Luminance
Grayscale .
Luminance Uniformity and Mura Test ●
Stability of Luminance and Chromaticity with Temperature and Lifetime ●
Bidirectional Reflection Distribution
Chromaticity and Gray Tracking .
. Color Scale
. Color Gamut Volume

Other non-clinical tests were performed on the proposed device to demonstrate that the proposed device complies with the following international and FDA-recognized standards:

IEC 60601-1:2005 Edition 3 + A1:2012 (Electrical safety) .
. ANSI AAMI 60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (Electrical safety)
. IEC 60601-1-2:2014 (EMC)
IEC 62304:2006 / A1:2015 (Software lifecycle process) .

Finally, to test the performance of the proposed device in use with its software accessories, System Integration tests have been performed.

The non-clinical bench tests have demonstrated that the proposed device has equivalent or higher performance and technical characteristics compared to the predicate device and performs according to the requirements for displays used in Digital Pathology Whole Slide Imaging Devices following the corresponding TPA quidance and display reguirements from FDA cleared IVD-labeled whole-slide imaging scanners and/or digital pathology image viewing software platforms.

Additional bench tests have demonstrated that the proposed device complicable international and FDA-recognized standards and can be used safely with its software accessories.

Conclusion

The proposed device MDPC-8127 is substantially equivalent with the predicate device in terms of intended use, technological characteristics, performance, safety and effectiveness.

Non-clinical tests according to the TPA guidance have been performed to assess the technical characteristics of the display for its intended use and have demonstrated that the MDPC-8127 has equivalent or better

P 4 / 5

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performance than the other devices under test; as well as compatible with FDA cleared IVD-labeled whole-slide imaging scanners and/or digital pathology image viewing software platforms.

The tests have demonstrated that the proposed device is as safe and effective as the predicate device. Additionally, it has been demonstrated that the proposed device may be used for primary diagnosis in the following validated FDA-cleared WSI systems and digital pathology viewing software:

Philips Intellisite Pathology Solution with Philips Image Management System viewing software, cleared . under K192259
. Philips Intellisite Pathology Solution with Paige.AI Inc. FullFocus DX viewing software, cleared under K201005
. Leica Aperio AT2 DX System with ImageScope DX viewing software, cleared under K190332
Leica Aperio AT2 DX scanner with Sectra Digital Pathology Module, cleared under K193054 .

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ENABLING BRIGHT OU

Regulation Number and Section

§ 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.