The RadiForce RX840 is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

Device Description

The RadiForce RX840 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 4096 x 2160 pixels (8MP), spacious enough to display e.g. two 3MP radiological images and other clinical information side by side without obtrusive bezels.

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 "RX840" such as "RX840-AR", a model with an Anti-Reflective coating.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX840 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.

AI/ML Overview

The provided text describes a 510(k) submission for the EIZO RadiForce RX840 8MP Color LCD Monitor. It does not contain information about a study with acceptance criteria for a device that uses AI or a human-in-the-loop component. Instead, it focuses on demonstrating substantial equivalence of the RX840 monitor to a predicate device (FlexScan MX300W) based on technological characteristics and performance benchmarks.

Therefore, many of the requested sections about AI-specific criteria, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance are not applicable to this document. The document describes a display monitor, not an AI diagnostic tool.

Here's a breakdown of the information that is present or can be inferred, along with explanations for the missing information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present explicit acceptance criteria in the typical sense for a diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, it focuses on demonstrating that the proposed device (RadiForce RX840) meets or exceeds the performance characteristics of its predicate device, the FlexScan MX300W. The "acceptance criteria" here are implicitly tied to the performance of the predicate device.

Characteristic	Predicate Device (FlexScan MX300W) Performance	Proposed Device (RadiForce RX840) Performance	Acceptance/Comparison Metric
Matrix Size (Resolution)	2,560 x 1,600	4,096 x 2,160 (8MP)	Larger than predicate
Active Area Size	641.3 mm x 400.8 mm	817.1 mm x 430.9 mm	Larger than predicate
Pixel Pitch/Size	0.2505 x 0.2505 mm	0.1995 x 0.1995 mm	Smaller (higher density) than predicate
DICOM Calibrated Luminance	170 cd/m²	400 cd/m²	Higher than predicate
Typical Maximum Luminance	300 cd/m²	700 cd/m²	Higher than predicate
Backlight Type	CCFL	LED	Newer, mercury-free, less power, slower deterioration
DICOM GSDF Compliance	Yes (via factory calibrated display modes)	Yes (via factory calibrated display modes)	Same as predicate
Input Video Signal	DVI	DVI, DisplayPort	Improved/additional options
QC Software	Uses same QC software (RadiCS/RadiCS LE)	Uses same QC software (RadiCS/RadiCS LE)	Same as predicate
Backlight Sensor (BS)	Present	Present	Same as predicate
Built-in Front Sensor (IFS)	Not explicitly mentioned	Present (for automatic grayscale calibration)	Improved (reduces human intervention)
Safety & EMC Standards	Not detailed for predicate	Validated (internationally recognized)	Meets standards
Image Quality Characteristics	Not detailed, but section 18 references comparison with predicate	Not detailed, but section 18 references comparison with predicate	"several image quality characteristics... compared"

The document states: "The RadiForce RX840 can be said to have at least the same display performances as those of the predicate device by default..." and "The specifications of the primary component employed by the proposed device are superior to those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness." This indicates that the "acceptance criteria" were met by demonstrating equivalence or superiority to the predicate device's established performance without introducing adverse effects.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is not a study involving patient data or a test set in the context of an AI algorithm. The performance evaluation is based on device specifications and benchmark testing of the monitor hardware and software.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. There is no "ground truth" establishment in the context of diagnostic interpretation for this monitor's submission. The "ground truth" for monitor performance would be established by objective measurements and adherence to technical standards.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic test set or adjudication process is described.

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 document describes a monitor, not an AI system. Therefore, an MRMC comparative effectiveness study regarding AI assistance is not applicable.

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

No. This is a display monitor, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is typically established by:

Engineering specifications and objective measurements: Calibrated luminance, resolution, pixel pitch, tone curve adherence (DICOM GSDF), color accuracy, etc.
Adherence to recognized standards: Safety (e.g., IEC 60601-1) and EMC standards.
Comparison to predicate device performance: Demonstrating that the new device's performance characteristics are equivalent or superior without raising new safety or effectiveness concerns.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set as it is not an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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K113226

DEC 1 7 2011

EIZO NANAO CORPORATION, 153 Shimokashiwano, Hakusan, Ishikawa

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 Device Standards
Telephone	+81 (76) 274-2468
Fax	+81 (76) 274-2484
E-Mail	hiro@nanao.co.jp
Date	October 28th, 2011

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

1. Date of Summary
  October 28th, 2011
1. Company EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan
1. Authorized Contact Person Hiroaki Hashimoto

4. Device Information

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

5. Predicate Device

Color LCD Monitor, FlexScan MX300W (K073340) .

6. Device Description

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Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX840" such as "RX840-AR", a model with an Anti-Reflective coating.

7. Intended Use

8. Technological Characteristics

The RadiForce RX840 can be said to have at least the same display performances as those of the predicate device by default due to the following reasons:

Both the matrix size and the active area size of the LCD panel used (4,096 x 2,160, a. 817.1 mm x 430.9 mm) are larger than those of the predicate device (2,560 x 1,600, 641.3 mm x 400.8 mm).
The smaller pixel pitch or pixel size (0.1995 x 0.1995 mm) than that of the predicate b. device (0.2505 x 0.2505 mm) 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.
The DICOM calibrated luminance (400 cd/m²) and the typical maximum luminance C. (700 cd/m2) is higher than that of the predicate device (170 cd/m², 300 cd/m²). The higher luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
d. The LED backlight was newly employed instead of CCFL backlight because it is mercury-free, consumes less power and deteriorates more slowly. We have not recognized any adverse effects of the LED backlight on the quality of displayed images. Refer to section 18 "Performance Testing - Bench" where several image quality characteristics of the proposed device are compared with those of the predicate device.
The both devices display images in accordance with DICOM GSDF by default e. utilizing the factory calibrated display mode stored in lookup tables inside of them.
As for input video signal, in addition to the Digital Visual Interface (DVI) also f. supported by the predicate device, RadiForce RX840 supports DisplayPort, another type of digital video interface based on an industrial standard. As far as the both the DVI and the DisplayPort are digital, their differences do not affect the quality of displayed images.

. + =

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As for the maintenance, the same QC software is used for the both devices and the implementation of the Backlight Sensor (BS) stabilizing the backlight is also the same.

As for built-in sensors, in addition to BS common to the both devices, RX840 has three kinds of sensors. However, only the Built-in Front Sensor (IFS) has something to do with the maintenance or the calibration; the Presence Sensor (PS) detects the absence of the user to trigger the power saving mode of the monitor and the Ambient Light Sensor (ALS) is used to measure the ambient light by lx. The IFS enables automatic grayscale calibration by measuring the luminance at the screen surface. Without IFS, the grayscale calibration process requires human intervention and the use of an external sensor. The accuracy data of the calibration with external sensors and that with the IFS is included in section 16.9 "Verification and Validation Documentation".

The overall design of the RadiForce RX840 was validated in accordance with internationally recognized safety and EMC standards by independent testing facilities and in-house ones. Besides, EIZO NANAO CORPORATION performed a range of system and performance tests to ensure that the RadiForce RX840 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

9. Conclusion

The 8MP color LCD monitor, RadiForce RX840 is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The specifications of the primary component employed by the proposed device are superior to those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.

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Image /page/3/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines representing the eagle's body.

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

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

DEC 1 7 2011

Re: K113226

Trade/Device Name: 8MP Color LCD Monitor, RadiForce RX840 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 31, 2011 Received: November 1, 2011

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 general controls 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 additional controls. 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 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 Parts 801 and 809); medical device reporting of

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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,

Mary Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): _K (ﺻﺎﺩ 3222

8MP Color LCD Monitor, RadiForce RX840 Device Name:

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Mictael D. Kher

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113224

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).