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

Device Description

RadiForce RX560 is a color LCD monitor for viewing medical images including those of mammography. The color 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, RX560 and RX560-AR . The difference of the two variations is the surface treatment of the display screens; the surface treatment of the RX560 is Anti-Glare (AG) treatment and that of the RX560-AR is Anti-Reflection (AR) coating.

Two RX560 monitors mounted on a single stand configuration is available identified by with "MD" like RX560-MD and RX560-AR-MD.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX560 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 RX560.

AI/ML Overview

The provided text describes a 510(k) summary for the EIZO RadiForce RX560, a color LCD monitor for medical imaging, including mammography and breast tomosynthesis. The document focuses on demonstrating substantial equivalence to a predicate device (RadiForce GX550) rather than presenting a standalone study with acceptance criteria for an AI-powered diagnostic device.

Therefore, many of the requested elements for an AI device's acceptance criteria and study are not applicable or cannot be extracted from this document, as it concerns a display monitor, not an AI algorithm.

However, I can extract the performance testing performed and the general findings related to the display characteristics.

Here's the breakdown of what can be inferred and what cannot, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document defines "pre-defined criteria" for the display characteristics, but the specific numerical values of these criteria are not explicitly stated. The reported performance is that the device "meet[s] the pre-defined criteria when criteria are set."

Acceptance Criteria	Reported Device Performance
Conformance to DICOM GSDF (TG18 guideline)	Meets criteria
Angular dependency of luminance response (horizontal, vertical, diagonal)	Meets criteria
Luminance non-uniformity (TG18 guideline)	Meets criteria
Chromaticity non-uniformity (TG18 guideline)	Meets criteria
Chromaticity at center (5%, 50%, 95% max luminance)	Meets criteria
Display reflections (specular, diffuse, haze)	Meets criteria
Small-spot contrast ratio	Meets criteria
Spatial resolution (MTF)	Meets criteria
Noise (NPS)	Meets criteria
Pixel aperture ratio	Meets criteria
Absence of miscellaneous artifacts (TG18 guideline)	Meets criteria
Temporal response	Meets criteria
Luminance stability	Meets criteria
Maximum allowed pixel defects/faults	Meets criteria
Overall display characteristics	Equivalent to predicate device (RadiForce GX550)

2. Sample size used for the test set and the data provenance

As this is a display monitor and the tests are "bench tests" on the device itself, there isn't a "test set" of medical images in the same way an AI algorithm would have. The 'sample size' would relate to the number of monitors tested, which is not specified but implied to be sufficient for a product release. Data provenance is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for display performance is based on established technical standards and guidelines (e.g., AAPM TG18), not expert interpretation of medical images.

4. Adjudication method for the test set

Not applicable. Testing is objective measurement against technical standards.

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 algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a display device. The "bench tests" are a form of standalone performance evaluation for the monitor itself.

7. The type of ground truth used

The ground truth is based on established technical specifications and performance guidelines for medical displays, specifically those outlined in:

AAPM Task Group 18 (TG18 guideline) for display performance assessment.
"Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions."

8. The sample size for the training set

Not applicable. This is a display device, not an AI algorithm. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable.

Summary

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November 8, 2017

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K172738

Trade/Device Name: RadiForce RX560, RX560-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: September 6, 2017 Received: September 12, 2017

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Hiroaki Hashimoto

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 mediation-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,

Michael D. O'Hara
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) K172738

Device Name RadiForce RX560, RX560-AR

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the EIZO logo. The logo consists of a stylized square with a checkered pattern on the left and the word "EIZO" in bold, sans-serif font on the right. A registered trademark symbol is located to the upper right of the "O" in "EIZO".

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

2. Contact Person

Hiroaki Hashimoto

1. Date of Summary September 6th, 2017

4. Device Information

Device Name: RadiForce RX560, RX560-AR ●
Trade Name/Model: RadiForce RX560, RX560-AR
Common Name: 54.1 cm (21.3 inch) class Color LCD Monitor ●
Classification Name: Display, Diagnostic Radiology
Regulation Number: 21 CFR 892.2050, Product Code PGY ●

5. Predicate Device

5MP Monochrome LCD Monitor, RadiForce GX550, GX550-AR (K162497)

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6. Device Description

Two RX560 monitors mounted on a single stand configuration is available identified by with "MD" like RX560-MD and RX560-AR-MD.

7. Indications for use

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

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8. Comparison of Technological Characteristics

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

Attributes	RadiForce RX560	RadiForce GX550	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	TFT ColorLCD Panel (IPS)	TFT MonochromeLCD Panel (IPS)	Monochrome vs. Color(w/o & w/ color filters).
Viewing angle(H, V)	H: 178°, V: 178°	H: 178°, V: 178°
Resolution	5MP (2,048 x 2,560)	5MP (2,048 x 2,560)
Aspect ratio	4 : 5	4 : 5
Active screensize	337.9 mm x 422.4 mm	337.9 mm x 422.4 mm
Pixel pitch	0.165 mm x 0.165 mm	0.165 mm x 0.165 mm
Maximumluminance	1,100 cd/m²	2,000 cd/m²	Both devices' Maximumand DICOM calibrated
DICOMcalibratedluminance	500 cd/m²	600 cd/m²	luminance are greaterthan 171cd/m² which isrequired for primarydisplays in AAPM On-line Report No. 03:2005(Sec. 4.3.4.2.1) withenough margin.
Contrast ratio	1500 : 1	1500 : 1
ResponseTime (typical)	12 ms (On/Off)	25 ms (On/Off)
Backlighting	LED	LED	-
Display Colors	10-bit colors(DisplayPort) : 1.07 billion(maximum) colors8-bit colors: 16.77 millionfrom a palette of 68 billioncolors	10-bit (DisplayPort): 1,024from a palette of 16,369tones8-bit: 256 from a palette of16,369 tones	Monochrome vs. Color
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	Digital UniformityEqualizer	-
Video Signals
Input videosignals	DVI-D (dual link) x 1,DisplayPort x 1	DVI-D (dual link) x 1,DisplayPort x 1	-
Output videosignals	DisplayPort x 1 (daisychain)	DisplayPort x 1 (daisychain)	-
ScanningFrequency (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	-
Power Related Specifications
PowerRequirements	AC 100 - 240 V:50 / 60 Hz	AC 100 - 240 V:50 / 60 Hz	-
PowerConsumption /Save Mode	87 W / Less than 1 W	95 W / Less than 1 W	-
PowerManagement	DVI DMPM,DisplayPort 1.2a	DVI DMPM,DisplayPort 1.2a	-
Miscellaneous Features/Specifications
QC software	RadiCS	RadiCS	-
Sensors	Backlight Sensor,Integrated Front Sensor,Presence Sensor,Ambient Light Sensor	Backlight Sensor,Integrated Front Sensor,Presence Sensor,Ambient Light Sensor	-
USB Ports /Standard	1 upstream,2 downstream / Rev. 2.0	1 upstream,2 downstream / Rev. 2.0	-
Dimensionsw/o stand(W x H x D)	354.5 x 452 x 78 mm	367 x 452 x 78 mm	-

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX560.

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9. Performance Testing

The bench tests below were performed on the RadiForce RX560 following the 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

The test results showed that the RadiForce RX560 has display characteristics equivalent to those of the predicate device, RadiForce GX550.

Besides, the display characteristics of the RadiForce RX560 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX560.

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10.Conclusion

The RadiForce RX560 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).