This product is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

Device Description

RadiForce GX560 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, GX560 and GX560-AR. The difference of the two variations is the surface treatment of the display screens; the surface treatment of the GX560 is Anti-Glare (AG) treatment and that of the GX560-AR is Anti-Reflection (AR) coating.

Two GX560 monitors mounted on a single stand configuration is available identified by with "MD" like GX560-MD and GX560-AR-MD.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce GX560 based on the QC standards and guidelines and is capable of quantitative tests and visual tests defined by them. The RadiCS and its subset, RadiCS LE, are included in this 510(k) submission as an accessory to the RadiForce GX560.

AI/ML Overview

The provided document is a 510(k) summary for the EIZO RadiForce GX560 and GX560-AR medical display monitors. It describes the device, its intended use, comparison to a predicate device, and performance testing. However, the document does not contain information about a study proving the device meets specific acceptance criteria based on human-in-the-loop performance, multi-reader multi-case studies, or AI assistance.

The "Performance Testing" section (page 7) describes bench tests performed on the RadiForce GX560, specifically to evaluate display characteristics. These tests are about the technical performance of the monitor itself (e.g., spatial resolution, luminance, temporal response, adherence to DICOM GSDF), not the diagnostic performance of a human reader using the display, nor are they related to AI assistance.

Therefore, I cannot fulfill your request for the following sections, as the information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance (in the context of clinical/diagnostic performance with human readers or AI). The document only gives technical acceptance criteria for the display's physical properties.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective). No clinical test set involving patient data is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience). No expert review or ground truth establishment is mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set. Not applicable.
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. The document explicitly states: "No animal or clinical testing was performed on the RadiForce GX560." This means no human reader studies, MRMC studies, or AI assistance studies were conducted or reported in this 510(k) summary.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done. This device is a display monitor, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc). Not applicable.
8. The sample size for the training set. Not applicable, as this is not an AI/algorithm device.
9. How the ground truth for the training set was established. Not applicable.

Summary of available information regarding acceptance criteria and performance (bench testing):

The document focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce GX550) based on technological characteristics and bench performance tests of the display itself.

Acceptance Criteria for the Display Device (as extracted from "7. Performance Testing"):

The general acceptance criteria for the RadiForce GX560 are stated as:

"The test results showed that the RadiForce GX560 has display characteristics equivalent to those of the predicate device, RadiForce GX550."
"Besides, the display characteristics of the RadiForce GX560 meet the pre-defined criteria when criteria are set." (Specific quantitative criteria are not detailed in this summary document, but typically refer to standards like TG18.)

Reported Device Performance (from "7. Performance Testing"):

The document states that the following bench tests were performed, and the results showed equivalence to the predicate device and met pre-defined criteria:

Measurement of spatial resolution expressed as modulation transfer function (MTF)
The maximum number allowed for each type of pixel defects/faults
Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
Measurement of temporal response
Measurement of Luminance
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
Performance data on luminance stability
Measurement of noise expressed as noise power spectrum (NPS)
Measurement of display reflections including specular, diffuse and haze components
Measurement of small-spot contrast ratio
Measurement of pixel aperture ratio

In conclusion, this 510(k) summary for a medical display monitor does not describe any studies related to human diagnostic performance, AI assistance, or the clinical effectiveness of the device in a diagnostic workflow. It solely focuses on the technical characteristics and performance of the display hardware to demonstrate substantial equivalence for its intended use in displaying radiological images.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 24th, 2018

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

Re: K181609

Trade/Device Name: RadiForce GX560, GX560-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 15, 2018 Received: June 19, 2018

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Jeff Balyer

for Robert Ochs. Ph.D. 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) K181609

Device Name RadiForce GX560, GX560-AR

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized, geometric shape on the left and the word "EIZO" in bold, sans-serif font on the right. The geometric shape is composed of squares and triangles, creating a textured, three-dimensional effect. A registered trademark symbol is located to the upper right of the letter O.

EIZO Corporation, 153 Shimokashiwano, Hakusan, Ishikawa 071-2566 Isnan

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 Regulatory Compliance and Safety

Telephone Fax E-Mail

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

510(k) Summary

1. Submitter

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

Contact Person: Hiroaki Hashimoto Date of Prepared: June 15th, 2018

2. Device

●

Name of Device: RadiForce GX560, GX560-AR
Common or Usual Name: 54.1 cm (21.3 inch) class Monochrome LCD Monitor ●
Classification Name: Picture archiving and communications system ● (21 CFR 892.2050)
Regulatory Class: II
Product Code: PGY

3. Predicate Device

EIZO Corporation RadiForce GX550, GX550-AR (K162497)

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4. Device Description

Two GX560 monitors mounted on a single stand configuration is available identified by with "MD" like GX560-MD and GX560-AR-MD.

5. Indications for use

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6. Comparison of Technological Characteristics with the predicate device

The comparison table below enumerates information derived from the product brochure and measured values of the each device and different technological characteristics are discussed in it:

Attributes	Proposed Device:RadiForce GX560	Predicate Device:RadiForce GX550
Display Technology	TFT MonochromeLCD Panel (IPS)	TFT MonochromeLCD Panel (IPS)
Screen size	54.1cm / 21.3"Aspect ratio: 4 : 5	54.1cm / 21.3"Aspect ratio: 4 : 5
Backlight type	LED	LED
Frame rate and refresh rate
Digital Scanning Frequency(H / V)	31 - 135 kHz / 23 - 61 HzFrame synchronous mode: 23.5- 25.5 Hz, 47 - 51 Hz	31 - 135 kHz / 23 - 61 HzFrame synchronous mode: 23.5- 25.5 Hz, 47 - 51 Hz
Display Interface
Input videosignals	DVI-D (dual link) x 1,DisplayPort x 2	DVI-D (dual link) x 1,DisplayPort x 1
Output videosignals	DisplayPort x 1 (daisy chain)	DisplayPort x 1 (daisy chain)
Video bandwidth	DVI : 290MHzDisplayPort : 290MHz	DVI : 290MHzDisplayPort : 290MHz
Ambient light sensing
Ambient light sensor	Yes	Yes
Luminance calibration tools
	Integrated optical sensorExternal optical sensorCalibration software:RadiCS	Integrated optical sensorExternal optical sensorCalibration software:RadiCS
Quality-control procedures
	Software: RadiCS	Software: RadiCS

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the GX560.

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7. Performance Testing

The bench tests below were performed on the RadiForce GX560 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017:

. Measurement of spatial resolution expressed as modulation transfer function (MTF)
The maximum number allowed for each type of pixel defects/faults .
. Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
Measurement of temporal response
Measurement of Luminance .
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
. Performance data on luminance stability
Measurement of noise expressed as noise power spectrum (NPS)
Measurement of display reflections including specular, diffuse and haze components ●
Measurement of small-spot contrast ratio
Measurement of pixel aperture ratio .

The test results showed that the RadiForce GX560 has display characteristics equivalent to those of the predicate device, RadiForce GX550.

Besides, the display characteristics of the RadiForce GX560 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce GX560.

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8. Conclusion

The RadiForce GX560 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 differences from those of the predicate device do not affect the safety or the effectiveness.
The bench tests demonstrated that the display characteristics are equivalent to those of . the predicate device.

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).