This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

Device Description

RadiForce MX217 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) with a pixel pitch of 0.270 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 MX217 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 MX217. RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX217 and it's not a medical imaging software.

AI/ML Overview

The provided text is a 510(k) summary for the EIZO RadiForce MX217 display device. This document focuses on demonstrating substantial equivalence to a predicate device (RadiForce MX216) rather than proving the device meets specific acceptance criteria based on a study with a test set, ground truth, or expert consensus in the way an AI/CADe device would.

The document discusses performance testing of the monitor itself, which involves technical measurements of display characteristics. It does not describe a study involving medical images, human readers, or AI algorithms for diagnostic purposes.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training/test set) are not applicable to this document as it pertains to a display device, not a diagnostic AI or image processing software that produces a diagnostic output.

However, I can extract the information related to the device's technical specifications and the bench tests conducted to show its performance regarding those specifications.

Here's an attempt to answer the questions based only on the provided text, highlighting where the information is not available or not applicable given the nature of the device (a display monitor):

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

The document states:
"The test results showed that the RadiForce MX217 has display characteristics equivalent to those of the predicate device, RadiForce MX216."
And:
"Besides, the display characteristics of the RadiForce MX217 meet the pre-defined criteria when criteria are set."

However, it does not explicitly list the "pre-defined criteria" or "acceptance criteria" in a quantitative table with corresponding performance values for each criterion. It only lists the types of tests performed.

Types of Bench Tests Performed:

Measurement/Test	Reported Performance
Measurement of spatial resolution (MTF)	Equivalent to predicate device (RadiForce MX216)
Maximum number allowed for each type of pixel defects/faults	Equivalent to predicate device (RadiForce MX216)
Visual check of miscellaneous artifacts (TG18 guideline)	Equivalent to predicate device (RadiForce MX216)
Measurement of temporal response	Equivalent to predicate device (RadiForce MX216)
Measurement of Luminance	Equivalent to predicate device (RadiForce MX216)
Conformance to DICOM GSDF (TG18 guideline)	Equivalent to predicate device (RadiForce MX216)
Measurement of Color tracking	Equivalent to predicate device (RadiForce MX216)

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

Sample Size: Not applicable. This is a display device, not an AI/CADe system. The "test set" would be the device itself undergoing various physical and photometric measurements. The document refers to "bench tests" performed on the RadiForce MX217.
Data Provenance: Not applicable. The "data" are measurements from the device, not clinical imaging data.

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

Not applicable. Ground truth in the context of clinical images or diagnostic outcomes is not relevant for testing a display monitor's technical performance. The "ground truth" for these tests would be the established technical standards (e.g., TG18 guidelines, DICOM GSDF) that the device is measured against.

4. Adjudication method for the test set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving discrepancies in expert interpretations of clinical data, which is not relevant for the technical testing of a display monitor.

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. This is a display device, not an AI/CADe system. An MRMC study is not relevant.

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

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

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

The "ground truth" for the performance tests of this display device refers to established industry standards and guidelines for display quality, such as:
- "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (September 28, 2022)
- "Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)"
- DICOM GSDF (Grayscale Standard Display Function)

8. The sample size for the training set

Not applicable. This is a display device, not an AI/machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. As there's no training set, there's no ground truth to establish for it.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K230684

May 12, 2023

Trade/Device Name: RadiForce MX217 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: March 13, 2023 Received: March 13, 2023

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

{1}------------------------------------------------

for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K230684

Device Name RadiForce MX217

Indications for Use (Describe)

This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K230684

Image /page/3/Picture/1 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 composed of squares and triangles, creating a textured, three-dimensional effect. A small registered trademark symbol is located to the upper right of the letter "O" in "EIZO".

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	Hiroaki Hashimoto
Department	Regulatory Compliance andSafety
Telephone	+81 (76) 274-2468
E-Mail	hiroaki.hashimoto@eizo.com

510(k) Summary

1. Submitter

EIZO Corporation 153 Shimokashiwano, Hakusan, Ishikawa 924-8566 Japan Phone: +81 (76) 274-2468

Contact Person: Hiroaki Hashimoto Date of Prepared: March 13th, 2023

2. Device

Name of Device: RadiForce MX217
Common or Usual Name: 21.3 inch (54.0 cm) Color LCD Monitor
Classification Name: Medical image management and processing system ● (21 CFR 892.2050) II
Regulatory Class:
. Product Code: PGY

3. Predicate Device

Name of Device: RadiForce MX216 (K190153) ●
Common or Usual Name: 54.1 cm (21.3 inch) class Color LCD Monitor ●
. Classification Name: Picture archiving and communications system (21 CFR 892.2050)
- II
Regulatory Class: PGY . Product Code:

{4}------------------------------------------------

4. 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 MX217 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 MX217.

RadiCS is of Minor level of concern and that it's being used unchanged from the predicate software. RadiCS supports the functions of the monitor RadiForce MX217 and it's not a medical imaging software.

5. Indications for use

This Product is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.

{5}------------------------------------------------

6. Comparison of Technological Characteristics with the predicate device

The comparison table below enumerates information derived from the product brochure and measured values of the each device and different technological characteristics are discussed in it:

Attributes	Proposed Device:RadiForce MX217	Predicate Device:RadiForce MX216
Indications for Use	This Product is indicated for usein displaying radiological imagesfor review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography.	This Product is indicated for usein displaying radiological imagesfor review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography.
Display Technology	TFT ColorLCD Panel (IPS)	TFT ColorLCD Panel (IPS)
Screen size	54.0cm / 21.3"Aspect ratio: 3 : 4	54.0cm / 21.3"Aspect ratio: 3 : 4
Backlight type	LED	LED
Frame rate and refresh rate
Digital Scanning Frequency(H / V)	31 - 100 kHz / 59 - 61 Hz	31 - 100 kHz / 59 - 61 Hz
Display Interface
Input video signals	DVI-D x 1,DisplayPort x 1	DVI-D x 1,DisplayPort x 1
Output video signals	DisplayPort x 1 (daisy chain)	DisplayPort x 1 (daisy chain)
Video bandwidth
	DVI : 25-164.5MHzDisplayPort : 25-164.5MHz	DVI : 164.5MHzDisplayPort : 164.5MHz
Ambient light sensing
Ambient light sensor	Photo DiodePosition: In the upper bezel of thescreenSoftware tool: RadiCS	Photo DiodePosition: In the upper bezel of thescreenSoftware tool: RadiCS
Luminance calibration tools
	Integrated optical sensorExternal optical sensorCalibration software: RadiCS	Integrated optical sensorExternal optical sensorCalibration software: RadiCS
Quality-control procedures
	Software: RadiCS	Software: RadiCS

{6}------------------------------------------------

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the MX217.

7. Performance Testing

The bench tests below were performed on the RadiForce MX217 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on September 28,2022:

Measurement of spatial resolution expressed as modulation transfer function (MTF)
The maximum number allowed for each type of pixel defects/faults ●
Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in TG18 guideline
Measurement of temporal response ●
Measurement of Luminance ●
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 Color tracking

The test results showed that the RadiForce MX217 has display characteristics equivalent to those of the predicate device, RadiForce MX216.

Besides, the display characteristics of the RadiForce MX217 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce MX217.

8. Conclusion

The RadiForce MX217 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).