This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

Device Description

RadiForce GX540 is a monochrome LCD monitor for viewing medical images including those of mammography. The monochrome panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 2,048 x 2,560 pixels (5MP) with a pixel pitch of 0.165 mm.

Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.

There are two model variations, GX540-CL and GX540-CLAR (GX540 without any suffix does not exist). The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX540-CL is Anti-Glare (AG) treatment and that of the GX540-CLAR is Anti-Reflection (AR) coating. The suffix common to the both variations, " - CL", means that the tint of the backlight is Clear Base (vs. Blue Base, another popular tint slightly bluish).

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX540 based on the OC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS is included in this 510(k) submission as an accessory to the RadiForce GX540.

AI/ML Overview

The provided document is a 510(k) premarket notification for the EIZO RadiForce GX540 5MP Monochrome LCD Monitor. This document is a submission to the FDA for a medical display device, not an AI/ML-driven diagnostic device. Therefore, many of the requested criteria often associated with AI/ML device studies (such as sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable or typically reported in this type of submission for a display monitor.

However, I can extract and present the available information related to acceptance criteria and performance testing for this device.

Acceptance Criteria and Reported Device Performance

Device: EIZO RadiForce GX540 5MP Monochrome LCD Monitor

Acceptance Criteria / Specification	Reported Device Performance (EIZO RadiForce GX540)	Predicate Device Specification (Barco MDMG-5221)
Resolution / Matrix Size	5MP (2,048 x 2,560)	5MP (2,048 x 2,560)
Screen Technology	TFT Monochrome LCD Panel (IPS)	TFT (Monochrome) AMLCD Dual Domain IPS WideView
Backlighting	LED	CCFL
Maximum Luminance	1,200 cd/m²	2,100 cd/m²
DICOM Calibrated Luminance	500 cd/m²	1,000 cd/m²
Viewing Angle (H, V)	H: 176°, V: 176°	176°
Active Screen Size	337.9 mm x 422.4 mm	337.9 mm x 422.4 mm
Aspect Ratio	4:5	4:5
Pixel Pitch	0.165 mm x 0.165 mm	0.165 mm x 0.165 mm
Contrast Ratio	1200:1	950:1
Grayscale Tones	10-bit (DisplayPort): 1,024 from a palette of 16,369 tones; 8-bit: 256 from a palette of 16,369 tones	Number of grayscales (LUT in/LUT out): 1024 gray levels (10/12)
Non-Uniformity Compensation	Digital Uniformity Equalizer (DUE)	Per Pixel Uniformity
Response Time (typical)	25 ms (On/Off)	15 ms (Tr + Tf)

Study Proving Acceptance Criteria:

The device's performance was evaluated through Bench Testing and Clinical Testing.

The bench tests were performed following instructions in the "Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions" and the AAPM Task Group 18 (TG18 guideline) for assessing display performance.

The clinical testing aimed to assess the image quality of tomosynthesis images on the proposed device compared to the predicate device.

Additional Requested Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Bench Testing: No sample size is explicitly stated for images or data sets. The tests are focused on the physical characteristics and performance of the monitor itself (e.g., luminance, contrast, resolution, temporal response).
- Clinical Testing: The document states the goal was to "assess the image quality of tomosynthesis images," but it does not specify the number of images or cases used for this assessment. The data provenance (country of origin, retrospective/prospective) is also not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Bench Testing: Ground truth is not applicable in the traditional sense for these technical display measurements. The "pre-defined criteria" for bench tests are based on established guidelines (FDA Guidance, TG18).
- Clinical Testing: The document states the clinical testing evaluated "viewing tomosynthesis images, especially lesions like masses, microcalcifications and architectural distortions within the images." This implies evaluation by medical practitioners, but the number or qualifications of these "trained medical practitioners" who assessed the images are not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified or applicable for either the bench or clinical testing described.
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:
- An MRMC study was done in the sense that medical practitioners evaluated images on the proposed device versus the predicate device. However, this study was not an AI-assisted study. It was a comparison of display monitors. The document states: "The results of the testing indicated that the proposed device is at least equivalent to the predicate device for viewing tomosynthesis images, especially lesions like masses, microcalcifications and architectural distortions within the images." No effect size related to AI assistance is applicable or reported.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a medical display monitor for human viewing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Bench Testing: The ground truth is the physical measurement against set technical standards (e.g., DICOM GSDF, TG18 guidelines).
- Clinical Testing: The "ground truth" implicitly relies on the subjective assessment of image quality by "trained medical practitioners" for identifying lesions. No objective ground truth like pathology or outcomes data is mentioned as being used to validate these visual assessments in the clinical test.
The sample size for the training set:
- Not applicable. This is a display monitor, not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 30, 2015

EIZO Corporation % Hiroaki Hashimoto Manager 153 Shimokashiwano Hakusan, 924-8566 JAPAN

Re: K151883

Trade/Device Name: 5MP Monochrome LCD Monitor, RadiForce GX540 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 3, 2015 Received: July 9, 2015

Dear Hiroaki Hashimoto:

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); medical device reporting (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health 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) K151883

Device Name

5MP Monochrome LCD Monitor, RadiForce GX540

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the EIZO logo. The logo consists of a stylized square shape with a checkered pattern on the left and the word "EIZO" in bold, sans-serif font on the right. The square shape has a wavy top edge and a jagged bottom edge. The word "EIZO" is followed by the registered trademark symbol.

EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Janan

U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - WO66-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002

Name Department

Hiroaki Hashimoto Medical System Standards

Telephone Fax E-Mail

+81 (76) 274-2468 +81 (76) 274-2484 hiroaki.hashimoto@eizo.com

510(k) Summary (in accordance with 21 CFR 807.92)

1. Company

EIZO Corporation 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484

Contact Person 2.

Hiroaki Hashimoto

3. Date of Summary

July 3rd, 2015

●

4. Device Information

Trade Name/Model: RadiForce GX540 ●
5MP Monochrome LCD Monitor ● Common Name:
- Classification Name: Display, Diagnostic Radiology
- 21 CFR 892.2050, Product Code PGY Regulation Number:
510(k) Number: K130336 (for digital mammography) ●

5. Predicate Device

Trade/Device Name: ●
510(k) Number: ●

Barco Mammo Tomosynthesis (MDMG-5221) K103792

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6. Device Description

7. Intended Use

This product is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.

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Comparison of Technological Characteristics 8.

The comparison table below enumerates information derived from the product brochure of the each device and other differences are discussed:

Attributes	EIZO RadiForceGX540	Barco MDMG-5221	Explanation ofDifferences
Display Performance/Specifications
ResponseTime(typical)	25 ms (On/Off)	15 ms (Tr + Tf)	EIZO uses typical dataprovided by the panelmanufacturer.See main text for furtherexplanation.
Resolution orMatrix Size	5MP (2,048 x 2,560)	5MP (2,048 x 2,560)	-
ScreenTechnology	TFT MonochromeLCD Panel (IPS)	TFT (Monochrome)AMLCD Dual DomainIPS WideView	-
Backlighting	LED	CCFL	See main text for furtherexplanation.
MaximumLuminance	1,200 cd/m²	2,100 cd/m²	The luminance ratio (max/min)between 250 and 650 generallyrecommended taking accountof the contrast sensitivity ofhuman eyes is available in theproposed devices. EIZO doesnot see merits of the extremelyhigh luminance offeringcontrast beyond what the eyescan see.
DICOMCalibratedLuminance	500 cd/m²	1,000 cd/m²	-
ViewingAngle (H, V)	H: 176°, V: 176°	176°	-
ActiveScreen Size	337.9 mm x 422.4 mm	337.9 mm x 422.4 mm	-
Aspect Ratio	4:5	4:5	-
Pixel Pitch	0.165 mm x 0.165 mm	0.165 mm x 0.165 mm	-
ContrastRatio	1200:1	950:1	-
GrayscaleTones	10-bit (DisplayPort): 1,024from a palette of 16,369tones8-bit: 256 from a palette of16,369 tones	Number of grayscales(LUT in/LUT out):1024 gray levels (10/12)	-
Attributes	EIZO RadiForceGX540	Barco MDMG-5221	Explanation ofDifferences
Non-UniformityCompensation	Digital UniformityEqualizer (DUE)	Per Pixel Uniformity	The both features are intended toimprove uniformity ofbrightness and color.
Video Signal Input
Input VideoSignals	DVI-D (dual link) x 1,DisplayPort x 1	DVI, DisplayPort	-
ScanningFrequency(H, V)	31 - 135 kHz / 24 - 61 HzFrame synchronousmode: 24.5 - 25.5 Hz, 49- 51 Hz	30-150 kHz; 15-80 Hz	-
Dot Clock	290 MHz	280 MHz	-
Power Related Specifications
PowerRequirements	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz	100 - 240 V	-
PowerConsumption	108 W / Less than 0.7 W	125 W (nominal)	-
PowerManagement	DVI DMPM,DisplayPort 1.1a	DVI-DMPM	-
Miscellaneous Features/Specifications			-
QC Software	RadiCS	MediCal QAWeb	-
Sensors	Integrated Front Sensor(IFS)	I-Guard	The both sensors/technologiesenable automatic grayscalecheck and calibration bymeasuring the luminance at thescreen surface.
	Backlight Sensor (BS)	Backlight OutputStabilization (BLOS)?	BS enables backlightbrightness stabilization bymeasuring the backlightbrightness directly and thefeature is very common tomedical displays.The implementation of BLOSon the predicate device is notcertain though the feature ismentioned in the overallproducts brochure.
	Ambient Light Sensor(ALS)	Hemispherical AmbientLight Sensor	-
Attributes	EIZO RadiForceGX540	Barco MDMG-5221	Explanation ofDifferences
	Presence Sensor (PS)	-	PS detects the absence of theuser as a trigger of the powersaving mode.
USB Ports /Standard	1 upstream,2 downstream / Rev. 2.0	1 upstream + 1 endpoint,2 downstream / Rev. 2.0	-
Dimensionsw/o Stand(W x H x D)	388 x 496 x 99 mm	392 x 484 x 123 mm	Different housing design dueto the different panel size.

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For the substantial equivalence determination, only the difference of the response time needs further evidences by performance testing for the proposed additional usage, "multi-frame digital mammography" or "digital breast tomosynthesis".

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9. Performance Testing

9.1. Bench Testing

The following bench tests were performed on the RadiForce GX540 following instructions in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions:

Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions
. Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline
Measurement of the chromaticity non-uniformity characteristics of the display screen . as specified in TG18 guideline
. Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance
Measurement of display reflections including specular, diffuse and haze components ●
Measurement of small-spot contrast ratio
. Measurement of spatial resolution expressed as modulation transfer function (MTF)
. Measurement of noise expressed as noise power spectrum (NPS)
Measurement of pixel aperture ratio
Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
. Measurement of temporal response
Performance data on luminance stability ●
The maximum number allowed for each type of pixel defects/faults agreed with the . manufacturer from which EIZO buys the LCD panels for RadiForce GX540

The test results showed that the display characteristics of the RadiForce GX540 meet the pre-defined criteria when criteria are set.

The corresponding testing data of the predicate device, Barco Mammo Tomosynthesis (MDMG-5221), was not available because the device is from other manufacturer.

9.2. Clinical Testing

The goal of the clinical testing was to assess the image quality of tomosynthesis images on the proposed device compared to that on the predicate device.

The results of the testing indicated that the proposed device is at least equivalent to the predicate device for viewing tomosynthesis images, especially lesions like masses, microcalcifications and architectural distortions within the images.

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9.3. Animal Testing

No animal testing was performed on the RadiForce GX540.

Conclusion 10.

The RadiForce GX540 was determined to be substantially equivalent to the predicate device due to the following reasons:

The stated intended use is substantially the same as that of the predicate device.
It was confirmed that the technological characteristics different from those of the . predicate device do not affect the safety and the effectiveness except one item, which was determined that it would not affect observer's performance based on the results of the clinical testing.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).