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

Device Description

RadiForce RS340 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 1.536 x 2.048 pixels (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 RS340 based on the OC 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 RS340.

AI/ML Overview

This document describes the EIZO Corporation 3MP Color LCD Monitor, RadiForce RS340, a device intended for displaying digital images for review, analysis, and diagnosis by trained medical practitioners (excluding mammography images).

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states that the RadiForce RS340 meets "pre-defined criteria when criteria are set" and that its display characteristics are "equivalent to those of the predicate device, RadiForce RX340 except one item, which was determined that it would not affect observer's performance." Specific numerical acceptance criteria are not explicitly detailed in the provided text. However, the performance tests conducted indicate the following areas of evaluation and implied criteria based on conformance to industry guidelines:

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to DICOM GSDF (AAPM TG18 guideline)	Verified conformance to DICOM GSDF.
Luminance non-uniformity characteristics (AAPM TG18 guideline)	Measurement performed; results show equivalence to predicate except for one item not affecting observer performance.
Chromaticity non-uniformity characteristics (AAPM TG18 guideline)	Measurement performed; results show equivalence to predicate except for one item not affecting observer performance.
Chromaticity at center (5%, 50%, 95% max luminance) (FDA Guidance for Mammography Display Accessories)	Measurement performed; results show equivalence to predicate except for one item not affecting observer performance.
Absence of miscellaneous artifacts (AAPM TG18 guideline)	Visual check performed; results show equivalence to predicate except for one item not affecting observer performance.
Spatial resolution (MTF)	Measurement performed; results show equivalence to predicate except for one item not affecting observer performance.
Maximum allowed pixel defects/faults	Test performed; results show equivalence to predicate except for one item not affecting observer performance.
Equivalence to Predicate Device (RadiForce RX340)	The RadiForce RS340 has display characteristics equivalent to those of the predicate device, RadiForce RX340, with one exception that was determined not to affect observer's performance. The device also meets "pre-defined criteria when criteria are set."

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of image data or patient studies. The performance testing described refers to bench tests performed on the RadiForce RS340 monitor itself. Therefore, there is no mention of sample size for a test set of data or its provenance (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. As noted above, the testing was focused on the monitor's technical performance characteristics, not on diagnostic accuracy based on medical images. Therefore, no ground truth established by medical experts for a test set was required or mentioned.

4. Adjudication method for the test set

Not applicable, for the same reasons as point 3.

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. The device is a medical display monitor, not an AI diagnostic algorithm. The testing described is for the display's technical performance.

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

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

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

The "ground truth" for the performance testing of the display monitor was based on established industry standards and guidelines, specifically:

AAPM Task Group 18 (TG18 guideline): For DICOM GSDF conformance, luminance non-uniformity, chromaticity non-uniformity, and visual checks for artifacts.
Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions: For chromaticity at the center of the display screen.

These guidelines define acceptable technical performance parameters for medical displays.

8. The sample size for the training set

Not applicable. This device is a display monitor, not a machine learning model; therefore, no training set was used.

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

Not applicable. As there was no training set, no ground truth for a training set was established.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.

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

November 18, 2014

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

Re: K143098

Trade/Device Name: 3MP Color LCD Monitor, RadiForce RS340 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: October 24, 2014 Received: October 28, 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,

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) K143098

Device Name 3MP Color LCD Monitor, RadiForce RS340

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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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 letters on the right. The geometric shape is a square divided into smaller squares, with a wavy 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 14th, 2014

4. Device Information

RadiForce RS340 ● Trade Name/Model:
Common Name: 3MP Color LCD Monitor ●
Classification Name: Display, Diagnostic Radiology .
Regulation Number: 21 CFR 892.2050, Product Code PGY ●

5. Predicate Device

3MP Color LCD Monitor, RadiForce RX340 (K113562) ●

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6. Device Description

7. Intended Use

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

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	RadiForceRS340	RadiForceRX340	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	IPS TFT Color LCDPanel	IPS TFT Color LCDPanel
Viewingangle (H, V)	H: 176°, V: 176°	H: 170°, V: 170°	Eizo uses typical data forvery low contrastprovided by the panelmanufacturers
Active screensize	324.8 mm x 433.1 mm	323.7 mm x 431.6 mm
Resolution	3MP (1,536 x 2,048)	3MP (1,536 x 2,048)
Aspect ratio	3 : 4	3 : 4	-
Pixel pitch	0.211 mm x 0.211 mm	0.21075 mm x 0.21075mm	-
Maximumluminance	800 cd/m²	1,000 cd/m²	Though the smallermaximum luminancevalue usually results inshorter period duringwhich the calibratedluminance can beguaranteed, theguaranteed operatingperiods of the bothdevices are the same.
DICOMcalibratedluminance	400 cd/m²	400 cd/m²	-
Contrast ratio	1400 : 1	1400 : 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-D (dual link) x 1,DisplayPort x 1	DVI-D (dual link) x 1,DisplayPort x 1	-
ScanningFrequency(H, V)	31 - 127 kHz / 29 - 61.5Hz (VGA Text: 69 - 71Hz)Frame synchronousmode: 29.5 - 30.5 Hz, 59- 61 Hz	31 - 127 kHz, 29 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 29.5 - 30.5 Hz,59 - 61 Hz	-
Power Related Specifications
PowerRequirements	AC 100 - 240 V: 50 / 60Hz	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz	-
PowerConsumption/ Save Mode	110 W / Less than 1.6 W	125 W / Less than 3 W	The proposed deviceconsumes less power thanthe predicate device inthe power saving mode.
PowerManagement	DVI DMPM,DisplayPort 1.1a	DVI DMPM,DisplayPort 1.1a	-
Miscellaneous Features/Specifications
QC software	RadiCS	RadiCS	-
Sensors	Backlight Sensor,Presence Sensor	Backlight Sensor,Presence Sensor,Integrated Front Sensor(IFS),Ambient Light Sensor	For the predicate devicewithout IFS, the use of anexternal sensor isassumed for QC tests andcalibration.
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)	376 x 505 x 98 mm	376 x 505 x 98 mm	-

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It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RS340.

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9. Performance Testing

The following bench tests were performed on the RadiForce RS340.

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 RS340 has display characteristics equivalent to those of the predicate device, RadiForce RX340 except one item, which was determined that it would not affect observer's performance.

Besides, the display characteristics of the RadiForce RS340 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RS340.

10. Conclusion

The RadiForce RS340 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 one item, 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).