This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Device Description

RadiForce MX215 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing wide viewing angles and the matrix size (or resolution) is 1.200 x 1.600 pixels (2MP). 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 the RadiForce MX215 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 MX215.

AI/ML Overview

The document describes the performance testing conducted for the EIZO RadiForce MX215 2MP Color LCD Monitor to demonstrate its substantial equivalence to the predicate device, RadiForce RS210.

Here's a breakdown of the requested information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly present a discrete "acceptance criteria" table with specific pass/fail thresholds alongside reported device performance for each criterion. Instead, it states that "the RadiForce MX215 has display characteristics equivalent to those of the predicate device, RadiForce RS210" and "meet the pre-defined criteria when criteria are set." The performance tests were primarily conducted based on established guidelines to ensure the device performs at least as well as the predicate and adheres to medical display standards.

However, based on the descriptions, we can infer the tested characteristics and the general performance goal:

Acceptance Criteria (Inferred from Guidelines/Predicate Equivalence)	Reported Device Performance
Conformance to DICOM GSDF (as per AAPM TG18 guideline)	Met
Luminance non-uniformity characteristics (as per TG18 guideline)	Met
Chromaticity non-uniformity characteristics (as per TG18 guideline)	Met
Chromaticity at center of display screen at 5%, 50%, 95% of maximum luminance (as per FDA Staff Guidance for Full-Field Digital Mammography Systems)	Met
Presence or absence of miscellaneous artifacts (as per TG18 guideline)	Met
Maximum number of allowed pixel defects/faults	Met
Equivalence of display characteristics to predicate device (RadiForce RS210)	Found to be equivalent

2. Sample Size and Data Provenance

Sample Size: The document does not specify a numerical sample size for the test set. It refers to "the RadiForce MX215" (singular), implying that the testing was performed on at least one unit of the device. Given the nature of monitor testing, it's common to test a representative sample rather than a large cohort.
Data Provenance: The document does not provide details about the country of origin of the data or whether the study was retrospective or prospective. It describes "bench tests" performed by EIZO Corporation.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not applicable. This study involved "bench tests" to evaluate the hardware performance of a display monitor, not a diagnostic algorithm that relies on expert interpretation for ground truth.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable, as this was a bench testing study for a display monitor's technical specifications, not an assessment requiring human interpretation and consensus for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is typically conducted for AI algorithms or diagnostic tools where the performance of human readers with and without AI assistance is being compared. This document describes the technical performance evaluation of a medical display monitor.
Effect Size of Human Reader Improvement: Not applicable.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Not applicable. The device is a display monitor, not an algorithm. The testing described is for the monitor's physical and display characteristics.

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for this study was based on pre-defined technical criteria and standards from recognized guidelines such as AAPM TG18 and FDA Staff Guidance for Display Accessories for Full-Field Digital Mammography Systems. It involved objective measurements of display characteristics (e.g., luminance, chromaticity, uniformity) and visual checks against established specifications, rather than clinical outcomes, pathology, or expert consensus on medical images.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. The RadiForce MX215 is a hardware device (a monitor), not a machine learning algorithm that requires a training set.

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

Ground Truth for Training Set: Not applicable, as there is no training set for a hardware device like a medical display monitor.

Summary

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

KB31090
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JUL 0 3 2013

EIZO 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 hiroaki.hashimoto@eizo.com

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

1. Company

EIZO Corporation 153 Shimokashiwano, Hakusan lshikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484

Contact Person

Hiroaki Hashimoto

3. Date of Summary April 15th, 2013

4. Device Information

Trade Name/Model: RadiForce MX215 .
Common Name: 2MP Color LCD Monitor .
. Classification Name: System, Image Processing, Radiological
Regulation Number: 21 CFR 892.2050, Product Code LLZ .

5. Predicate Device

2MP Color LCD Monitor, RadiForce RS210 (K092613) .

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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.

RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including the RadiForce MX215 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 MX215.

7. Intended Use

8. Comparison of Technological Characteristics

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

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Attributes	Eizo RadiForceMX215	Eizo RadiForceRS210	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	TFT Monochrome LCDPanel (IPS)	TFT Monochrome LCDPanel (IPS)
Viewingangle (H, V)	H: 178°, V: 178°	H: 170°, V: 170°	Eizo uses typical data forvery low contrastprovided by the panelmanufacturers
Active screensize	324.0 mm x 432.0 mm	432.0 mm x 324.0 mm
Resolution	2MP (1,200 x 1,600)	2MP (1,600 x 1,200)
Aspect ratio	3 : 4	4 : 3
Pixel pitch	0.270 mm x 0.270 mm	0.270 mm x 0.270 mm
Maximumluminance	420 cd/m²	300 cd/m²
DICOMcalibratedluminance	180 cd/m²	150 cd/m²
Contrast ratio	1500 : 1	1000 : 1	Eizo uses typical contrastratio data provided bypanel manufacturers.
Backlighting	LED	CCFL	See main text.
DisplayColors	From a palette of 68billion colors:- 10-bit (DisplayPort):1.07 billion colors(maximum)- 8-bit colors: 16.77million colors	From a palette of 68billion colors:- 10-bit (DisplayPort):1.07 billion colors(maximum)- 8-bit colors: 16.77million colors
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	Digital UniformityEqualizer
Video Signal Input
Input videosignals	DVI-I x 1,DisplayPort x 1	DVI-I x 2 ,DisplayPort x 1
ScanningFrequency(H, V)	Digital : 31 - 76 kHz / 59- 61 Hz (VGA Text: 69 -71 Hz)Analog : 26 - 80 kHz / 49- 76 Hz	Digital : 31 - 100 kHz /59 - 61 Hz (VGA Text:69 - 71 Hz)Analog : 31 - 100 kHz /49 - 86 Hz (1600 x 1200:49 - 61 Hz) ,Frame synchronousmode: 59 - 61 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	48 W / Less than 0.5 W	64 W / Less than 1 W	-
PowerManagement	Digital: DVI DMPM,DisplayPort 1.1aAnalog: VESA DPM	Digital: DVI DMPM,DisplayPort 1.1aAnalog: VESA DPM	-
Miscellaneous Features/Specifications
QC software	RadiCS	RadiCS	-
Sensors	Backlight Sensor (BS),Integrated Front Sensor (IFS),Presence Sensor (PS)	Backlight Sensor	Among two sensors notimplemented on RS210,only the IFS hassomething to do with themaintenance or thecalibration; the PS detectsthe absence of the user totrigger the power savingmode of the monitor.The IFS enablesautomatic grayscalecalibration by measuringthe luminance at thescreen surface.
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)	360 x 485 x 64 mm	472 x 373 x 69 mm	Different housing designdue to the different panelsize

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For the substantial equivalence determination, only the difference of the backlight technologies needs further evidences by performance testing.

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K131090
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9. Performance Testing

The following bench tests were performed on the RadiForce MX215.

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 luminance non-uniformity characteristics of the display screen as specified in the TG18 guideline
Measurement of the chromaticity non-uniformity characteristics of the display screen as . specified in the TG18 guideline
Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% . of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
Visual check of presence or absence of miscellaneous artifacts on the display screen as ● specified in the TG18 guideline
The maximum number allowed for each type of pixel defects/faults .

The test results showed that the RadiForce MX215 has display characteristics equivalent to those of the predicate device, RadiForce RS210.

Besides, the display characteristics of the RadiForce MX215 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX215.

10.Conclusion

The 2MP Color LCD Monitor, RadiForce MX215 has the same intended use as the predicate device but has one different technological characteristics. Bench testing showed that the safety and effectiveness of the RadiForce MX215 was not affected by the difference of the technological characteristics. Therefore, the RadiForce MX215 was determined to be substantially equivalent to the predicate device.

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DEPARTMENT OF BEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-C1609 Silver Spring, MD 20993-0002

July 3, 2013

EIZO Corporation % Mr. Hiroaki Hashimoto Manager 153 Shimokashiwano. Hakusan lshikawa 924-8566 JAPAN

Re: K131090

Trade/Device Name: 2MP Color LCD Monitor, RadiForce MX215 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: April 18, 2013 Received: May 2. 2013

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 10 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

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Page 2 - Mr. Hashimoto

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/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 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Jaming M. Menge

Janine M. Morris 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): K 131090

Device Name:

2MP Color LCD Monitor, RadiForce MX215

Indications for Use:

This product is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.

It does not support the display of mammography images for diagnosis.

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 In Vitro Diagnostics and Radiological Health (OIR)

Ramingh. Hess.

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K131090 510(k)

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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).