The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

Device Description

The RadiForce RX840-MG 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 RX840-MG is an alternate replacement for traditional dual head 5MP display installations.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the EIZO RadiForce RX840-MG, based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria (from TG18 guideline & pre-defined)	Reported Device Performance (RadiForce RX840-MG)
Conformance to DICOM GSDF	Met criteria (Test results showed conformance)
Angular dependency of luminance response (horizontal, vertical, diagonal)	Measured and found to be equivalent to predicate device, with differences not affecting observer performance.
Luminance non-uniformity characteristics	Measured and found to be equivalent to predicate device, with differences not affecting observer performance.
Chromaticity non-uniformity characteristics	Measured and found to be equivalent to predicate device, with differences not affecting observer performance.
Chromaticity at center of display (5%, 50%, 95% max luminance)	Measured. Specific results not detailed but implied to meet criteria or not affect observer performance.
Display reflections (specular, diffuse, haze)	Measured. Specific results not detailed but implied to meet criteria or not affect observer performance.
Small-spot contrast ratio	Measured. Specific results not detailed but implied to meet criteria or not affect observer performance.
Spatial resolution (Modulation Transfer Function - MTF)	Measured. Specific results not detailed but implied to meet criteria or not affect observer performance.
Noise (Noise Power Spectrum - NPS)	Measured. Specific results not detailed but implied to meet criteria or not affect observer performance.
Pixel aperture ratio	Measured. Specific results not detailed but implied to meet criteria or not affect observer performance.
Absence of miscellaneous artifacts	Visually checked and met criteria (No mention of artifacts affecting performance).
Temporal response	Measured. Specific results not detailed but implied to meet criteria or not affect observer performance.
Luminance stability	Performance data on luminance stability reviewed. Implied to meet criteria or not affect observer performance.
Maximum allowed pixel defects/faults (agreed with panel manufacturer)	Met criteria (Implied, as the device was deemed substantially equivalent).

Note: The document explicitly states: "The test results showed that the RadiForce RX840-MG has display characteristics equivalent to those of the predicate device, RadiForce GX530 except 4 items, each of which was determined that it would not affect observer's performance. Besides, the display characteristics of the RadiForce RX840-MG meet the pre-defined criteria when criteria are set." The specific 4 items and their exact deviation are not detailed, but the overall conclusion is that any differences do not negatively impact performance or safety.

Study Details

Sample Size used for the test set and the data provenance:
- The study involved bench testing of the RadiForce RX840-MG display monitor.
- The "test set" in this context refers to the physical device itself and its components, not a dataset of medical images or patient data.
- Data provenance: Not directly applicable as this is a device performance test, not a clinical study with patient data. The device itself is manufactured by EIZO NANAO CORPORATION in Japan.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This was a bench test of a display monitor, not a study requiring expert readers to establish ground truth for medical diagnoses.
- The "ground truth" was established by objective measurements against established technical guidelines (AAPM Task Group 18, DICOM GSDF) and pre-defined criteria. There is no mention of human experts being used to establish ground truth for the test set itself.
Adjudication method for the test set:
- Not applicable. As a bench test of a display monitor, there was no adjudication of discrepant readings or interpretations. The performance was measured directly.
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, a MRMC comparative effectiveness study was not done.
- This submission is for a medical display monitor, not an AI-powered diagnostic tool. The purpose was to show the display's technical performance characteristics.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the testing was effectively a "standalone" performance evaluation of the monitor itself, without any human interaction influencing the measurement of its technical specifications. However, it's not an "algorithm-only" performance as it's a hardware device. The device's performance was evaluated independently against technical standards.
The type of ground truth used:
- Technical Benchmarks and Standards: The ground truth was based on established quality control guidelines and standards for medical displays, specifically:
  - DICOM GSDF (Grayscale Standard Display Function)
  - AAPM Task Group 18 (TG18 guideline)
  - Pre-defined criteria set by the manufacturer for various display characteristics.
The sample size for the training set:
- Not applicable. This is a bench test for a hardware device, not a machine learning model that requires a training set. The device itself is manufactured, not "trained."
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a hardware display monitor.

Summary

{0}------------------------------------------------

K|2045|

Image /page/0/Picture/1 description: The image shows the logo for EIZO. The logo consists of a square shape with a checkered pattern on the left side and the word "EIZO" in bold letters on the right side. The logo is black and white and has a registered trademark symbol next to the letter O.

3 2012 AUG

	Name	Hiroaki Hashimoto
	Department	Medical System Standards
U.S. Food and Drug AdministrationCenter for Devices and Radiological Health	Telephone	+81 (76) 274-2468
Document Mail Center – WO66-G609	Fax	+81 (76) 274-2484
10903 New Hampshire AvenueSilver Spring, MD 20993-0002	E-Mail	hiro@nanao.co.jp
	Date	February 3rd, 2012

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

1. Date of Summary

February 3rd, 2012

2. Company

EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan

3. Authorized Contact Person

Hiroaki Hashimoto

4. Device Information

Trade Name/Model: RadiForce RX840-MG .
Common Name: 8MP Color LCD Monitor .
Classification Name: System, Image Processing, Radiological .
21 CFR 892.2050, Product Code LLZ . Regulation Number:

5. Predicate Device

. 5MP Monochrome LCD Monitor, RadiForce GX530 (K112354)

{1}------------------------------------------------

6. Device Description

Image /page/1/Picture/2 description: The image shows two different medical monitors. The monitor on the left is a RadiForce RX360-MG, and the two monitors on the right are 5MP monitors. All three monitors are displaying medical images. The monitors are all black and have a thin bezel.

RadiForce RX840-MG

5MP Monochrome Monitors

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. This helps ensure tone curves even if a display controller or workstation must be replaced or serviced.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce RX840-MG based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce RX840-MG.

7. Intended Use

The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

{2}------------------------------------------------

8. Comparison of Technological Characteristics

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

Attributes	Eizo RadiForceRX840-MG	Eizo RadiForceGX530	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	TFT ColorLCD Panel (IPS)	TFT MonochromeLCD Panel (IPS)	Monochrome vs. Color(w/o & w/ color filters).See main text.
Viewingangle (H, V)	H: 176°, V: 176°	H: 170°, V: 170°	Eizo uses the typical datafor very low contrast 10:1given by the panelmanufacturers
Active screensize	817.1 x 430.9 mm(408.05 x 430.9 mm x 2)	337.9 x 422.4mm	The difference of 400pixels in verticaldirection
Resolution	8 MP (4,096 x 2,160)(4MP: 2,048 x 2,160 x 2)	5 MP (2,048 x 2,560)	direction is such adegree that it can beeasily negated e.g. by asmall amount ofpanning manipulationor by changing the toolbar setting of theviewer software(location, disappearwhen the cursor isn'ton it etc.)
Aspect ratio	17 : 9(8.5 : 9 x 2)	4 : 5
Pixel pitch	0.1995 x 0.1995 mm	0.165 x 0.165 mm
Maximumluminance	700 cd/m²	1,200 cd/m²	Smaller maximumluminance value meansshorter period duringwhich calibratedluminance can beguaranteed: RX840-MG:10K hours vs. GX530:40K hours.
DICOMcalibratedluminance	500 cd/m²	500 cd/m²
Contrast ratio	1000: 1	1200 : 1	Eizo uses typical contrastratio data provided bypanel manufacturers.
Backlighting	LED	CCFL	See main text.
GrayscaleTones	10-bit:1,024 from a palette of4,096 tones8-bit: 256 from a paletteof 4096 tones	10-bit (DisplayPort):1,024 from a palette of16,369 tones8-bit: 256 from a paletteof 16,369 tones	See main text.
Luminancenon-uniformitycompensation	Digital UniformityEqualizer (DUE)	Digital UniformityEqualizer (DUE)
Video Signal Input
Input videosignals	DVI-D (Dual Link) x 2,DisplayPort x 2	DVI-D (Dual Link) x 1 ,DisplayPort x 1
ScanningFrequency(H, V)	31 - 140 kHz, 29.5 - 30.5Hz (2048 x 2160, 1920 x2160), 59 - 61 Hz,(VGA Text: 69 - 71 Hz)Frame synchronousmode: 29.5 - 30.5 Hz,59 - 61 Hz	31 - 135 kHz, 24 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 24.5 - 25.5 Hz,49 - 51 Hz
Dot Clock	DVI-D: 310 MHz,DisplayPort: 290 MHz	290 MHz
Displaycontroller	Off the shelf	Off the shelf
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	350 W / Less than 6 W	130 W / Less than 2.5 W	Theproposeddeviceconsumes morepowerdue 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 (BS),Integrated Front Sensor(IFS),Presence Sensor (PS),Ambient Light Sensor(ALS)	Backlight Sensor (BS),Integrated Front Sensor(IFS),Presence Sensor (PS),Ambient Light Sensor(ALS)
USB Ports /	1 upstream,	1 upstream,
Standard	2 downstream / Rev. 2.0	2 downstream / Rev. 2.0
Dimensionsw/o stand(W x H x D)	896 x 527 x 157 mm	388 x 496 x 99 mm	Different housing designdue to the different panelsize.

{3}------------------------------------------------

{4}------------------------------------------------

For the substantial equivalence determination, only the following differences of the technological characteristics need further evidences by performance testing:

' The RadiForce RX840-MG employs a color LCD panel module though the predicate device employs a monochrome LCD panel module.
. The smaller number of gray tones available to calibration of the color display (e.g. to GSDF) than that of the monochrome display may affect calibration accuracy.
-The RadiForce RX840-MG employs an LED backlight though the predicate device employs a CCFL backlight; advantage of the LED backlight is that it is mercury-free, consumes less power and deteriorates more slowly.

9. Performance Testing

The following bench tests were performed on the RadiForce RX840-MG 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 RX840-MG

{5}------------------------------------------------

The test results showed that the RadiForce RX840-MG has display characteristics equivalent to those of the predicate device, RadiForce GX530 except 4 items, each of which was determined that it would not affect observer's performance. Besides, the display characteristics of the RadiForce RX840-MG meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX840-MG.

10. Conclusion

The 8MP Color LCD Monitor, RadiForce RX840-MG to be used in dual-head configuration has the same intended use as the predicate device but some different technological characteristics. Bench testing showed that the safety and effectiveness of the RadiForce RX840-MG was not affected by the differences of the technological characteristics. Therefore, the RadiForce RX840-MG was determined to be substantially equivalent to the predicate device.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three tails, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The text is in all caps and is written in a sans-serif font. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

3 2012 AUG

Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation 153 Shimokashiwano HAKUSAN ISHIKAWA 924-8566 JAPAN

Re: K120451

Trade/Device Name: 8MP Color LCD Monitor, RadiForce RX840-MG Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 17, 2012 Received: July 19, 2012

Dear Mr. 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 I o a may) ontrols provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 Jour wortols. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 r total of acreating 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 compy "Har an an an an and 809); medical device reporting (reporting (reporting of

{7}------------------------------------------------

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

Indications for Use Form

510(k) Number (if known): _

8MP Color LCD Monitor, RadiForce RX840-MG Device Name:

Indications for Use:

The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

Over-The-Counter Use X Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

sion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K1200451

Page 1 of 1

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).