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 RX850 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. With the matrix size (or resolution) of 4,096 x 2,160 pixels (8MP), the RX850 is an alternate replacement for traditional dual head 5MP display installations.

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.

Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX850" such as "RX850-AR", a model with an Anti-Reflective film lamination.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX850 based on the OC 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 RX850.

AI/ML Overview

The provided document describes the FDA 510(k) premarket notification for the EIZO RadiForce RX850 and RX850-AR 8MP Color LCD Monitor. It does not provide the kind of study detailed in the request. The main point of the document is to demonstrate "substantial equivalence" to a predicate device, not to showcase the device's performance against specific acceptance criteria through a clinical or reader study in the way requested.

Here's an analysis of why the requested information cannot be fully provided based on the given text and what information is available:

1. Table of acceptance criteria and reported device performance:

The document lists several "bench tests" performed on the RadiForce RX850. While these are performance measurements, they are not presented as "acceptance criteria" with specific pass/fail thresholds in a table format that can be directly compared to a reported device performance. The conclusion states: "The test results showed that the RadiForce RX850 has display characteristics equivalent to those of the predicate device, RadiForce GX540 except some items, each of which was determined that it would not affect observer's performance. Besides, the display characteristics of the RadiForce RX850 meet the pre-defined criteria when criteria are set." This implies that internal criteria were met but they are not explicitly detailed in the document.

Therefore, a table cannot be fully constructed as requested. However, the types of performance tests conducted are:

Acceptance Criteria (Implied)	Reported Device Performance (Implied as "equivalent to predicate" or "meets pre-defined criteria")
Conformance to DICOM GSDF	Verified
Angular dependency of luminance response	Measured (determined not to affect observer performance)
Luminance non-uniformity	Measured (determined not to affect observer performance)
Chromaticity non-uniformity	Measured (determined not to affect observer performance)
Chromaticity at specific luminance levels	Measured
Display reflections (specular, diffuse, haze)	Measured
Small-spot contrast ratio	Measured
Spatial resolution (MTF)	Measured
Noise (NPS)	Measured
Pixel aperture ratio	Measured
Absence of miscellaneous artifacts	Visually checked
Temporal response	Measured
Luminance stability	Performance data available
Pixel defects/faults	Maximum allowed number determined

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

Sample size: Not applicable or not provided. This document describes a monitor, not an AI or diagnostic algorithm tested with a dataset of cases. The "test set" here refers to the monitor itself undergoing various display performance measurements.
Data provenance: Not applicable. The tests are on the device's display characteristics, not on a medical image dataset.

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" here is the physical performance of the monitor as measured by various technical standards and instruments, not clinical diagnoses made by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As described above, this is about device performance, not clinical interpretation.

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:

No. This is a medical display device, not an AI algorithm. There is no mention of an MRMC study or AI assistance.

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

No. This is a medical display device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the device's technical performance is established through defined measurement methodologies and technical standards (e.g., DICOM GSDF, AAPM TG18 guideline).

8. The sample size for the training set:

Not applicable. This is not an AI algorithm that requires a training set.

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

Not applicable.

Summary:

The provided text is an FDA 510(k) clearance document for a medical display monitor. It focuses on demonstrating "substantial equivalence" of the new monitor to a legally marketed predicate device through technical bench tests, ensuring that the new device's display characteristics do not negatively impact safety or effectiveness. It does not involve clinical studies with patient data, AI algorithms, or human reader performance evaluation, which are the typical contexts for the detailed questions about acceptance criteria, ground truth, and reader studies.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

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

November 20, 2015

EIZO Corporation % Hiroaki Hashimoto Manager of Medical Systems Standards Division 153 Shimokashiwano Hakusan, Ishikawa, 924-8566 JAPAN

Re: K152713

Trade/Device Name: 8MP Color LCD Monitor, RadiForce RX850, RX850-AR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: PGY Dated: September 16, 2015 Received: September 21, 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.

Mecha D'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) K152713

Device Name

8MP Color LCD Monitor, RadiForce RX850, RX850-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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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. 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	Hiroaki Hashimoto
Department	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 15th, 2015

4. Device Information

Trade Name/Model: RadiForce RX850, RX850-AR ●
Common Name: 8MP 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 GX540 (K151883) ●

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6. Device Description

Image /page/4/Picture/2 description: The image shows a computer monitor displaying two mammogram images side by side. The mammograms are grayscale and show the internal structure of the breasts. The monitor is black and has a silver stand.

RadiForce RX850

Image /page/4/Picture/4 description: The image shows two computer monitors displaying what appears to be medical scans, possibly mammograms. The monitors are side-by-side, each showing a similar image of what looks like breast tissue. The scans are in grayscale, with varying shades indicating different densities or structures within the tissue. The monitors have a black frame and are supported by a stand.

5MP Monochrome Monitors

Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX850" such as "RX850-AR", a model with an Anti-Reflective film lamination.

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.

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:

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Attributes	Display Performance/Specifications		Explanation of Differences
	RadiForce RX850 / RX850-AR	RadiForce GX540
Screen technology	TFT Color LCD Panel (IPS)	TFT Monochrome LCD Panel (IPS)	Monochrome vs. Color (w/o & w/ color filters). Eizo uses typical data for very low contrast provided by the panel manufacturers.
Viewing angle (H, V)	H: 178°, V: 178°	H: 176°, V: 176°	Eizo uses typical data for very low contrast provided by the panel manufacturers.
Resolution	8MP (4,096 x 2,160) (4MP: 2,048 x 2,160 x 2)	5MP (2,048 x 2,560)	The difference of 400 pixels in vertical direction is such a degree that it can be easily negated e.g. by a small amount of panning manipulation or by changing the tool bar setting of the viewer software (location, disappear when the cursor isn't on it etc.)
Aspect ratio	17 : 9 (8.5 : 9 x 2)	4 : 5	is such a degree that it can be easily negated e.g. by a small amount of panning manipulation or by changing the tool bar setting of the viewer software (location, disappear when the cursor isn't on it etc.)
Active screen size	697.9 mm x 368.0 mm	337.9 mm x 422.4 mm
Pixel pitch	0.1704 mm x 0.1704 mm	0.165 mm x 0.165 mm	The smaller pixel pitch or pixel size means higher density usually resulting in higher quality of displayed images. If one cares about the smaller pixel size, the perceived pixel size similar to that of the predicate device can be realized easily by adjusting the viewing distance.
Maximum luminance	850 cd/m²	1,200 cd/m²	The luminance ratio (max/min) between 250
DICOM calibrated luminance	500 cd/m²	500 cd/m²	and 650 generally recommended taking account of the contrast sensitivity of human eyes is available in the proposed devices. EIZO does not see merits of the extremely high luminance offering contrast beyond what the eyes can see.
Contrast ratio	1450 : 1	1200:1	Eizo uses typical contrast ratio data provided by panel manufacturers.
Response Time (typical)
20 ms (On/Off)	25 ms (On/Off)	-
Backlighting	LED	LED	LED
GrayscaleTones	From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors	10-bit (DisplayPort): 1,024from a palette of 16,369tones8-bit: 256 from a palette of16,369 tones	The smaller number ofgray tones available tocalibration of the colordisplay (e.g. to GSDF)than that of themonochrome display mayaffect calibrationaccuracy.
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	Digital UniformityEqualizer	-
Video Signal Input
Input videosignals	DVI-D (dual link) x 2,DisplayPort x 2(two inputs are required)	DVI-D (dual link) x 1,DisplayPort x 1	-
ScanningFrequency (H,V)	31 - 140 kHz / 59 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronous mode:29.5 - 30.5 Hz, 59 - 61 Hz	31 - 135 kHz / 24 - 61 HzFrame synchronous mode:24.5 - 25.5 Hz, 49 - 51 Hz	-
Power Related Specifications
PowerRequirements	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz	-
PowerConsumption /Save Mode	227 W / Less than 6 W	108 W / Less than 0.7 W	The proposed deviceconsumes more powerdue to the larger panelsize.
PowerManagement	DVI DMPM,DisplayPort 1.1a	DVI DMPM,DisplayPort 1.1a	-
Miscellaneous Features/Specifications
QC software	RadiCS	RadiCS	-
Sensors	Backlight Sensor,Integrated Front Sensor,Presence Sensor,Ambient Light Sensor	Backlight Sensor, IntegratedFront 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)	747 x 430 x 130 mm	388 x 496 x 99 mm	Different housing designdue to the different panelsize.

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX850.

9. Performance Testing

The bench tests below were performed on the RadiForce RX850 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 RX850 has display characteristics equivalent to those of the predicate device, RadiForce GX540 except some items, each of which was determined that it would not affect observer's performance.

Besides, the display characteristics of the RadiForce RX850 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX850.

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10.Conclusion

The RadiForce RX850 was determined to be substantially equivalent to the predicate device due to the following reasons:

The stated intended use is completely 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).