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 MX242W 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 with the matrix size (or resolution) of 1,920 x 1,200 pixels (2.3MP).

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 MX242W 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 MX242W.

AI/ML Overview

This document is a 510(k) premarket notification for a medical display, the EIZO RadiForce MX242W. As such, it describes performance testing conducted to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets specific acceptance criteria related to clinical diagnostic accuracy or reader performance. The "acceptance criteria" here refer to technical display performance specifications.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the tests performed and the comparison to the predicate device. The document explicitly states that "The test results showed that the RadiForce MX242W has display characteristics equivalent to those of the predicate device, RadiForce MX270W," and "Besides, the display characteristics of the RadiForce MX242W meet the pre-defined criteria when criteria are set."

Acceptance Criteria/Test	Predicate Device (RadiForce MX270W) Performance (or implicitly acceptable range)	RadiForce MX242W Performance (Reported as compliant/equivalent)
Conformance to DICOM GSDF (AAPM TG18 guideline)	(Implied compliant)	Conforms to DICOM GSDF
Luminance non-uniformity characteristics (TG18 guideline)	(Implied acceptable)	Meets specified characteristics
Chromaticity non-uniformity characteristics (TG18 guideline)	(Implied acceptable)	Meets specified characteristics
Chromaticity at 5%, 50%, 95% max luminance (Display Accessories for FFDM guideline)	(Implied acceptable)	Meets specified characteristics
Absence of miscellaneous artifacts (TG18 guideline)	(Implied acceptable)	Free of miscellaneous artifacts
Spatial resolution (MTF)	(Implied acceptable)	Meets specified spatial resolution
Maximum number of pixel defects/faults	(Implied acceptable)	Meets specified maximum number of pixel defects/faults
Resolution	3.7MP (2,560 x 1,440)	2.3MP (1,920 x 1,200) - Difference acknowledged, but deemed not to affect safety/effectiveness
Aspect ratio	16:9	16:10 - Difference acknowledged, but deemed not to affect safety/effectiveness
Active screen size	596.7 mm x 335.6 mm	518.4 mm x 324.0 mm - Difference acknowledged, but deemed not to affect safety/effectiveness
Pixel pitch	0.233 mm x 0.233 mm	0.270 mm x 0.270 mm - Difference acknowledged, but deemed not to affect safety/effectiveness
DICOM calibrated luminance	170 cd/m²	180 cd/m²

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

The "test set" in this context refers to bench testing of the device itself, not a dataset of medical images.

Sample Size: This information is not explicitly provided for the bench tests. It likely refers to testing of a single or a small number of production units.
Data Provenance: The tests were performed in the manufacturer's facility, likely in Japan (country of origin for EIZO Corporation). This was prospective testing on the manufactured device.

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

Not applicable. This is not a study involving human interpretation of medical images or establishment of medical ground truth. The "ground truth" for the bench tests is based on established technical standards and guidelines (e.g., DICOM GSDF, AAPM TG18).

4. Adjudication Method for the Test Set

Not applicable. There's no human interpretation or adjudication involved in the technical bench tests; rather, physical measurements and comparisons to defined technical standards are performed.

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 MRMC comparative effectiveness study was done. This device is a display monitor, not an AI diagnostic algorithm. The aim was to show substantial equivalence to a predicate display, not to evaluate human reader performance with or without AI. The document explicitly states: "No animal or clinical testing was performed on the RadiForce MX242W."

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

Not applicable. This is a medical display, not an algorithm.

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

The "ground truth" for the display's performance evaluation refers to established technical specifications and performance criteria from industry standards and regulatory guidance documents, such as:

AAPM Task Group 18 (TG18 guideline)
Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
DICOM GSDF (Grayscale Standard Display Function)

8. The sample size for the training set

Not applicable. This device is a display monitor, not an AI algorithm that requires a training set.

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

Not applicable. (See #8)

Summary of the Study (Bench Testing):

The study was a series of bench tests conducted on the EIZO RadiForce MX242W monitor. The purpose was to demonstrate substantial equivalence to a legally marketed predicate device (RadiForce MX270W) as required for a 510(k) submission. The tests evaluated technical display characteristics against established industry guidelines and standards to ensure the new device performs acceptably for its intended use, which is displaying medical images for review and analysis by trained practitioners (excluding mammography). Although there were some differences in resolution, aspect ratio, and physical size compared to the predicate, these differences were argued not to affect the safety and effectiveness of the device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.

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

November 21, 2014

EIZO CORPORATION c/o HIROAKI HASHIMOTO 153 SHIMOKASHIWANO HAKUSAN, ISHIKAWA 924-8566 JAPAN

Re: K143261

Trade/Device Name: 2.3MP Color LCD Monitor, RadiForce MX242W Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: November 11, 2014 Received: November 13, 2014

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. 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,

Robert A Ochs

for

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) K143261

Device Name

2.3MP Color LCD Monitor, RadiForce MX242W

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized, geometric shape on the left and the word "EIZO" in bold, sans-serif font on the right. The geometric shape is a square divided into smaller squares, with a jagged edge at the top. The "O" in "EIZO" has a registered trademark symbol next to it.

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

Hiroaki Hashimoto Name 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 November 20th, 2014

4. Device Information

RadiForce MX242W ● Trade Name/Model:
Common Name: 2.3MP Color LCD Monitor ●
Classification Name: Display, Diagnostic Radiology .
Regulation Number: 21 CFR 892.2050, Product Code PGY ●

5. Predicate Device

3.7MP Color LCD Monitor, RadiForce MX270W (K113240) .

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6. Device Description

7. Intended Use

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	RadiForceMX242W	RadiForceMX270W	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	IPS TFT Color LCDPanel	IPS TFT Color LCDPanel
Viewingangle (H, V)	H: 178°, V: 178°	H: 178°, V: 178°	Eizo uses typical data forvery low contrastprovided by the panelmanufacturers
Resolution	2.3MP (1,920 x 1,200)	3.7MP (2,560 x 1,440)	The panel used by the
Aspect ratio	16:10	16 : 9	proposed device issmaller and provides
Active screensize	518.4 mm x 324.0 mm	596.7 mm x 335.6 mm	lower resolution (=smaller matrix size).
Pixel pitch	0.270 mm x 0.270 mm	0.233 mm x 0.233 mm	If one cares about thedifferent pixel size, theperceived pixel sizesimilar to that of thepredicate device can berealized easily byadjusting the viewingdistance.
Maximumluminance	350 cd/m²	300 cd/m²
DICOMcalibratedluminance	180 cd/m²	170 cd/m²
Contrast ratio	1000 : 1	1000 : 1	Eizo uses typical contrastratio data provided bypanel manufacturers.
Backlighting	LED	LED
DisplayColors	From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors	From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07billion colors(maximum)- 8-bit input: 16.77million colors
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	Digital UniformityEqualizer
Video Signal Input
Input videosignals	DVI-I x 1,DisplayPort x 1	DVI-D x 1,DisplayPort x 1	The proposed devicesupports an analog video
ScanningFrequency(H, V)	Digital: 31 - 76 kHz / 59 -61 Hz (VGA Text: 69 -71 Hz)Frame synchronousmode: 59 - 61 HzAnalog: 26 - 76 kHz / 49- 71 Hz (VGA Text: 69 -71 Hz)Frame synchronousmode: 59 - 61 Hz	31 - 89 kHz, 29.5 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 29.5 - 30.5 Hz,59 - 61 Hz	interface, which has beensupported by otherdevices cleared for 510(k)like RadiForce RS210(K092613).
Power Related Specifications
PowerRequirements	AC 100 - 240 V,50 / 60 Hz	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz
PowerConsumption/ Save Mode	68 W / Less than 0.5 W	93 W / Less than 1 W	The proposed deviceconsumes less power.
PowerManagement	Digital: DVI DMPM,DisplayPort 1.1aAnalog: VESA DPM	DVI DMPM,DisplayPort 1.1a	VESA DPM, a powermanagement feature foranalog video interface, issupported by theproposed device.
Miscellaneous Features/Specifications
QC software	RadiCS	RadiCS
Sensors	Backlight Sensor	Backlight Sensor,Integrated Front Sensor	The both devices arecapable of QC tests andcalibration with anexternal 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)	575 x 398 x 71 mm	646 x 402 x 72.5 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 MX242W.

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9. Performance Testing

The following bench tests were performed on the RadiForce MX242W.

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
. Measurement of spatial resolution expressed as modulation transfer function (MTF)
. The maximum number allowed for each type of pixel defects/faults

The test results showed that the RadiForce MX242W has display characteristics equivalent to those of the predicate device, RadiForce MX270W, except two items, each of which was determined that it would not affect observer's performance.

Besides, the display characteristics of the RadiForce MX242W meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX242W.

10. Conclusion

The RadiForce MX242W was determined to be substantially equivalent to the predicate device due to the following reasons:

. The stated intended use is substantially the same as that of the predicate device.
It was confirmed that the technological characteristics different from those of the ● predicate device do not affect the safety and the effectiveness.
The bench tests demonstrated that the display characteristics are equivalent to those of the predicate device except two items, each of which was determined that it would not affect observer's performance.

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).