The RadiForce RX340 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 RX340 is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.21075 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. RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX340 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 RX340.

AI/ML Overview

The provided document is a 510(k) summary for the EIZO RadiForce RX340 3MP Color LCD Monitor. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial for an AI-powered diagnostic device would.

This document describes a medical display monitor and its substantial equivalence to a predicate device, not an algorithm that generates a diagnosis or interpretation. Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable to this type of device submission.

Instead, the submission focuses on technical characteristics and performance benchmarks compared to a predicate device to demonstrate substantial equivalence.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" against which an algorithm's performance is measured. Instead, it compares the proposed device's technical specifications and performance to those of a predicate device (RadiForce RX320). The "acceptance criteria" are implicitly that the proposed device must perform at least as well as the predicate device in key display characteristics, or that any differences do not affect safety or effectiveness.

Characteristic	Predicate Device (RadiForce RX320) Performance	Proposed Device (RadiForce RX340) Performance	Meets Implied Acceptance Criteria?
Panel Matrix Size/Resolution	1536 x 2048 pixels (3MP)	1536 x 2048 pixels (3MP)	Yes (Same)
Active Area Size	323.7 mm x 431.6 mm	323.7 mm x 431.6 mm	Yes (Same)
Pixel Pitch	(Not specified for predicate, assumed same)	0.21075 mm	Yes (Same, as panel is same)
DICOM Calibrated Luminance	400 cd/m²	400 cd/m²	Yes (Same)
Typical Maximum Luminance	900 cd/m²	1000 cd/m²	Yes (Higher, which is considered an improvement)
Backlight Type	CCFL	LED	Yes (Improved, mercury-free, less power, slower deterioration)
DICOM GSDF Compliance	Yes (via factory calibrated modes)	Yes (via factory calibrated modes)	Yes (Same)
Supported Video Inputs	Digital Visual Interface (DVI)	DVI, DisplayPort	Yes (Adds a new standard without affecting quality)
QC Software	RadiCS / RadiCS LE	RadiCS / RadiCS LE	Yes (Same)
Backlight Sensor (BS)	Present	Present	Yes (Same functionality)
Built-in Front Sensor (IFS)	Not explicitly mentioned but implies absence	Present	Yes (Enhance, allows auto grayscale calibration)
Presence Sensor (PS)	Not mentioned	Present	Not directly comparable, but an added feature for power saving
Ambient Light Sensor (ALS)	Not mentioned	Present	Not directly comparable, but an added feature for ambient light measurement
International Safety/EMC Standards Compliance	(Implied for predicate)	Validated by independent and in-house facilities	Yes (Validated)

2. Sample Size for the Test Set and Data Provenance

Not applicable in the context of an algorithm's test set. The "test set" here refers to the actual monitor units evaluated. The document states: "EIZO NANAO CORPORATION performed a range of system and performance tests to ensure that the RadiForce RX340 performs in accordance with its specifications." It does not specify the number of units tested, but it is typical for manufacturers to test a representative sample during design validation. Data provenance is internal testing by the manufacturer.

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

Not applicable. "Ground truth" in this context would relate to the physical characteristics of the display itself (e.g., luminance, resolution, color accuracy), which are measured using calibrated instruments, not expert human assessment.

4. Adjudication Method for the Test Set

Not applicable. Measurements are objective and do not require expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This type of study is relevant for comparing the diagnostic performance of human readers with and without AI assistance for interpreting medical images. The RadiForce RX340 is a display monitor, not an AI diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. The device is a monitor, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for validating the monitor's performance is based on objective physical measurements of its display characteristics (e.g., luminance, color temperature, resolution, DICOM GSDF compliance) using calibrated testing equipment. It also includes compliance with international safety and EMC standards.

8. The Sample Size for the Training Set

Not applicable. This is a hardware device (monitor), not a machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for a monitor.

Summary

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.K.113562

JUL 16 2012

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

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 hiro@nanao.co.jp

Date

November 28th, 2011

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

· 1. Date of Summary
November 28th, 2011
1. Company EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan

3. Authorized Contact Person

Hiroaki Hashimoto

4. Device Information

Trade Name/Model: RadiForce RX340 .
3MP Color LCD Monitor Common Name: .
System, Image Processing, Radiological Classification Name: .
Classification Number: 21 CFR 892.2050. Product Code LLZ �

5. Predicate Device

Color LCD Monitor, RadiForce RX320 (K090045) .

6. Device Description

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.

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Section 05

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Model variations with cosmetic differences are distinguished by characters attached to the name of the base model "RX340" such as "RX340-AR", a model with an Anti-Reflective coating although the hardware design, components and labeling remain unchanged.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including RX340 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 RX340.

7. Intended Use

8. Technological Characteristics

The RadiForce RX340 can be said to have at least the same display performances as those of the predicate device by default due to the following reasons:

The matrix sizes (1536 x 2048) and the active area sizes (323.7 mm x 431.6 mm) of a. the LCD panels used by the both devices are the same.
The DICOM calibrated luminance values of the both devices are the same (400 b. cd/m²) though the typical maximum luminance values (1000 cd/m²) is higher than that of the predicate device (900 cd/m2). The higher luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
The LED backlight was newly employed instead of CCFL backlight because it is C. 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 d. 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 e. supported by the predicate device, RadiForce RX340 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.

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, RX340 has three kinds of sensors. However, only the Built-in Front Sensor (IFS) has something to do with the

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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 RX340 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 RX340 performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.

9. Conclusion

The 3MP Color LCD Monitor, RadiForce RX340 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 the same 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 shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol. 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

Mr. Hiroaki Hashimoto Manager of Medical System Standards Division EIZO NANAO Corporation 153 Shimokashiwano HAKUSAN ISHIKAWA 924-8566 JAPAN

JUL 16 2012

Re: K113562

Trade/Device Name: 3MP Color LCD Monitor, RadiForce RX340. Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 28, 2012 Received: July 5, 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 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 (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,

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

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Image /page/5/Picture/0 description: The image shows the logo for EIZO. The logo consists of a square made up of smaller squares on the left and the word "EIZO" on the right. The square is black and white, and the word "EIZO" is black. There is a registered trademark symbol next to the O in EIZO.

Indications for Use

510(k) Number (if known):

K11.3562

Device Name:

3MP Color LCD Monitor, RadiForce RX340

Indications For Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR .

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Imhild O'Hara

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K113562

Indications for Use Statement_RX340: Page 1 of 1

Section 04

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).