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 MX315W 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 4,096 x 2,160 pixels (8MP) with a pixel pitch of 0.1704 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 the RadiForce MX315W 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 MX315W.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical display device, the EIZO RadiForce MX315W. It outlines the device's technical specifications and compares them to a predicate device, the RadiForce RX840. The document focuses on demonstrating substantial equivalence rather than presenting an AI-powered device.

Therefore, the document does not contain information about an AI/ML-powered medical device and its performance studies regarding acceptance criteria.

The questions posed are relevant to AI/ML device submissions, which typically involve performance studies demonstrating accuracy, sensitivity, specificity, or reader improvement. This document is for a display monitor and focuses on physical display characteristics rather than diagnostic performance metrics of an AI algorithm.

Here's why the requested information cannot be extracted from the provided text:

No AI/ML Component: The device, RadiForce MX315W, is a color LCD monitor used for displaying medical images. It does not incorporate artificial intelligence or machine learning for image analysis, diagnosis, or any form of algorithmic assistance.
Acceptance Criteria & Performance: The "performance testing" described (Section 9) pertains to the display's physical and optical characteristics (e.g., DICOM GSDF conformance, luminance non-uniformity, chromaticity, MTF, pixel defects). It is about the monitor's fidelity in displaying images, not the diagnostic performance of an AI algorithm. No quantitative metrics like sensitivity, specificity, accuracy, or AUC are mentioned.
No Test Set/Ground Truth: Since there's no AI algorithm being evaluated for diagnostic performance, there's no concept of a "test set" of medical images for algorithm validation, "ground truth" derived from expert consensus or pathology, or "training set" for an AI model.
No Expert Readers/Adjudication/MRMC Study: The device is a display. While medical practitioners use it, the document does not describe studies where human readers interpret images with or without AI assistance, or where experts establish ground truth for an AI's performance. Therefore, MRMC studies, expert qualifications, and adjudication methods are not applicable and not present.
No Standalone Performance: The device is hardware; it doesn't have a "standalone performance" in the context of an algorithm.

In summary, the provided text is about a medical display monitor and does not offer the necessary information to answer the questions about acceptance criteria and study data for an AI/ML-powered medical device.

Summary

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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three overlapping profiles of human faces, oriented to the right. The profiles are depicted in a minimalist style, with flowing lines suggesting hair and facial features.

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

April 27, 2017

EIZO Corporation Hiroaki Hashimoto Manager Medical System Standards 153 Shimokashiwano. Hakusan Ishikawa 924-8566 JAPAN

Re: K170949

Trade/Device Name: RadiForce MX315W Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: PGY Dated: March 27, 2017 Received: March 31, 2017

Dear Hiroaki 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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/ResourcesforYou/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.

Robert Oals

Robert Ochs, Ph.D. 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)

Device Name RadiForce MX315W

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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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, some of which are shaded to create a checkered pattern. The "EIZO" text is in black, and there is a small "®" symbol next to the "O".

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 Ishikawa 924-8566 Japan Tel: +81 (76) 274-2468 Fax: +81 (76) 274-2484

2. Contact Person

Hiroaki Hashimoto

1. Date of Summary March 27th, 2017

4. Device Information

RadiForce MX315W Device Name: .
Trade Name/Model: RadiForce MX315W
Common Name: 79.0 cm (31.1 inch) class Color LCD Monitor ●
Classification Name: ● Display, Diagnostic Radiology
Regulation Number: ● 21 CFR 892.2050, Product Code PGY

5. Predicate Device

8MP Color LCD Monitor, RadiForce RX840 (K113226)

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6. Device Description

7. Indications for 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.

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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:

Attributes	RadiForce MX315W	RadiForce RX840	Explanation ofDifferences
Display Performance/Specifications
Screentechnology	TFT ColorLCD Panel (IPS)	TFT ColorLCD Panel (IPS)
Viewing angle(H, V)	H: 178°, V: 178°	H: 176°, V: 176°	-
Resolution	8MP (4,096 x 2,160)	8MP (4,096 x 2,160)
Aspect ratio	17 : 9	17 : 9
Active screensize	697.9 mm x 368.0 mm	817.1 mm x 430.9 mm
Pixel pitch	0.1704 mm x 0.1704 mm	0.1995 mm x 0.1995 mm
Maximumluminance	450 cd/m²	700cd/m²	Both devices'Maximum and
DICOMcalibratedluminance	270 cd/m²	400 cd/m2	DICOM calibratedluminance are greaterthan 171cd/m2 whichis required forprimary displays inAAPM On-lineReport No. 03:2005(Sec. 4.3.4.2.1) withenough margin.
Contrast ratio	1300 : 1	1000: 1
ResponseTime (typical)	20 ms (On/Off)	25 ms (On/Off)
Backlighting	LED	LED
Display Colors	10-bit colors(DisplayPort) : 1.07 billion(maximum) colors8-bit colors: 16.77 millionfrom a palette of 68 billioncolors	10-bit colors(DisplayPort) : 1.07 billion(maximum) colors8-bit colors: 16.77 millionfrom a palette of 68 billioncolors
Luminancenon-uniformitycompensation	Digital UniformityEqualizer	Digital UniformityEqualizer
Video Signals
Input videosignals	DVI-D (dual link) x 1,DisplayPort x 2	DVI-D (dual link) x 2,DisplayPort x 2

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Output video signals	DisplayPort x 1 (daisy chain)	-
Scanning Frequency (H, V)	31 - 134 kHz / 14 - 61 Hz,(VGA Text: 69 - 71 Hz)Frame synchronous mode:29.5 - 30.5 Hz, 59 - 61 Hz	31 - 140 kHz / 29.5 - 30.5 Hz (2048 x 2160, 1920 x 2160),59 - 61 Hz, (VGA Text: 69 - 71 Hz)Frame synchronous mode:29.5 - 30.5 Hz, 59 - 61 Hz
Power Related Specifications
Power Requirements	AC 100 - 240 V:50 / 60 Hz	AC 100 - 120 V,200 - 240 V: 50 / 60 Hz
Power Consumption / Save Mode	125 W / Less than 1.6 W	350 W / Less than 6 W
Power Management	DVI DMPM,DisplayPort 1.2a	DVI DMPM,DisplayPort 1.1a
Miscellaneous Features/Specifications
QC software	RadiCS	RadiCS
Sensors	Backlight Sensor,Integrated Front Sensor,Presence Sensor,Ambient Light Sensor	Backlight Sensor,Integrated Front Sensor,Presence Sensor,Ambient Light Sensor
USB Ports / Standard	2 upstream,3 downstream / Rev. 2.0	1 upstream,2 downstream / Rev. 2.0
Dimensions w/o stand(W x H x D)	733 x 408 x 64.5 mm	896 x 527 x 157 mm

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MX315W.

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9. Performance Testing

The following bench tests were performed on the RadiForce MX315W.

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 TG18 guideline
. Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline
. Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance
Visual check of presence or absence of miscellaneous artifacts on the display screen . as specified in 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 MX315W has display characteristics equivalent to those of the predicate device, RadiForce RX840.

Besides, the display characteristics of the RadiForce MX315W meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX315W.

10. Conclusion

The RadiForce MX315W 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 differences from those of the predicate device do not affect the safety or the effectiveness.
. The bench tests demonstrated that the display characteristics are equivalent to those of the predicate device.

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).