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 RX370 is a color LCD monitor for viewing medical images other than those of mammography. The color panel employs in-plane switching (IPS) technology allowing high contrast ratio and the matrix size (or resolution) is 1,536 x 2,048 pixels (3MP) with a pixel pitch of 0.2115 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 RX370 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 RX370.

AI/ML Overview

The provided text describes a 510(k) submission for the EIZO RadiForce RX370, a medical display monitor. The document confirms that the device is substantially equivalent to a predicate device and outlines performance testing conducted. However, the document does not contain the specific details required to answer all parts of your request regarding acceptance criteria and a study that proves the device meets those criteria.

Here's a breakdown of what can be extracted and what information is missing:

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

The document mentions that the RadiForce RX370 meets "pre-defined criteria when criteria are set" for its display characteristics, and that it has "display characteristics equivalent to those of the predicate device, RadiForce RX360." It lists several performance tests conducted, but it does not provide a table with specific numerical acceptance criteria and the corresponding reported device performance values.

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

The document explicitly states: "No animal or clinical testing was performed on the RadiForce RX370." Therefore, there is no "test set" in the context of patient data or clinical images, and thus no sample size or data provenance to report in that sense. The tests mentioned were "bench tests" performed on the device itself.

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

Since no clinical or animal testing was performed, there was no "test set" requiring expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable, as no clinical or animal testing with a test set was 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:

Not applicable. The device is a display monitor, not an AI-powered diagnostic tool. No MRMC study was mentioned or implied.

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

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

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

Given that the performance testing involved "bench tests" on the display monitor itself, the "ground truth" would be the technical specifications and standards (e.g., DICOM GSDF, TG18 guidelines) against which the monitor's performance (luminance, MTF, pixel defects, etc.) was measured.

8. The sample size for the training set:

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

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

Not applicable.

Summary of available information regarding acceptance criteria and study:

The device is a medical display monitor (RadiForce RX370) intended for displaying radiological images.

Acceptance Criteria and Reported Device Performance (Partial based on available info):

Acceptance Criteria Category	Criteria (as implied)	Reported Device Performance (as implied)	Study Type
Spatial Resolution (MTF)	Conformance to specifications	Met pre-defined criteria; equivalent to predicate device.	Bench Test
Pixel Defects/Faults	Maximum number allowed	Met pre-defined criteria; equivalent to predicate device.	Bench Test
Miscellaneous Artifacts	Absence of artifacts (TG18)	Met pre-defined criteria; equivalent to predicate device.	Bench Test
Temporal Response	Conformance to specifications	Met pre-defined criteria; equivalent to predicate device.	Bench Test
Luminance	Conformance to specifications	Met pre-defined criteria; equivalent to predicate device.	Bench Test
DICOM GSDF Conformance	Conformance to TG18 guideline	Met pre-defined criteria; equivalent to predicate device.	Bench Test
Pixel Aperture Ratio	Conformance to specifications	Met pre-defined criteria; equivalent to predicate device.	Bench Test
Color Tracking	Conformance to specifications	Met pre-defined criteria; equivalent to predicate device.	Bench Test

Study Information:

Study Name: Performance Testing (Bench Tests)
Device Under Test: RadiForce RX370
Sample Size (Test Set): Not applicable (no clinical or animal testing). The "sample" would be the individual monitor unit(s) subjected to the bench tests.
Data Provenance: Not applicable (no patient/clinical data).
Ground Truth Establishment (for Test Set): Technical specifications and guidelines outlined in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" (October 2, 2017) and AAPM Task Group 18 (TG18 guideline).
Number of Experts/Qualifications: Not explicitly stated, but the tests are based on established industry guidelines that would have been developed by experts in the field.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: No.
Standalone Performance Study: Not applicable (device is a monitor, not an algorithm).
Training Set Sample Size: Not applicable.
Training Set Ground Truth: Not applicable.

In essence, the "study" proving the device meets acceptance criteria was a series of engineering/technical bench tests designed to ensure the display characteristics of the RadiForce RX370 met established standards for medical monitors and were equivalent to its predicate device.

Summary

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July 12, 2021

Image /page/0/Picture/1 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K211491

Trade/Device Name: RadiForce RX370 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: May 10, 2021 Received: May 13, 2021

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. 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name RadiForce RX370

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)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for EIZO. To the left of the name is a gray, geometric shape that is a square with a jagged top and bottom. The name EIZO is in all caps and in a bold, sans-serif font. There is a registered trademark symbol to the upper right of 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 Regulatory Compliance and Safety

Telephone Fax E-Mail

+81 (76) 274-2468 +81 (76) 274-2484 hiroaki.hashimoto@eizo.com

510(k) Summary K211491

1. Submitter

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

Contact Person: Hiroaki Hashimoto Date of Prepared: May 10th, 2021

2. Device

Name of Device: RadiForce RX370
Common or Usual Name: 54.1 cm (21.3 inch) class Color LCD Monitor ●
. Classification Name: Medical image management and processing system (21 CFR 892.2050)
Regulatory Class: II
Product Code: PGY

3. Predicate Device

EIZO Corporation RadiForce RX360, RX360-AR (K182591)

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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 RX370 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 RX370.

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.

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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 RX370	Predicate Device:RadiForce RX360
Display Technology	Color (IPS)	Color (IPS)
Screen size	54.1cm / 21.3"Aspect ratio: 3 : 4	54.1cm / 21.3"Aspect ratio: 3 : 4
Backlight type	LED	LED
Frame rate and refresh rate
Digital Scanning Frequency (H / V)	31 - 127 kHz / 29 - 61.5 Hz(VGA Text: 69 - 71 Hz)Frame synchronous mode: 29.5 - 30.5 Hz, 59 - 61 Hz	31 - 127 kHz / 29 - 61.5 Hz(VGA Text: 69 - 71 Hz)Frame synchronous mode:29.5 - 30.5 Hz, 59 - 61 Hz
Display Interface
Input video signals	DVI-D (dual link) x 1,DisplayPort x 2	DVI-D (dual link) x 1,DisplayPort x 2
Output video signals	DisplayPort x 1 (daisy chain)	DisplayPort x 1 (daisy chain)
Video bandwidth	DVI : 25-215MHzUp to 165MHz: Single LinkOver 165MHz: Dual LinkDisplayPort : 25-215MHz	DVI : 215MHzDisplayPort : 215MHz
Ambient light sensing
Ambient light sensor	Yes	Yes
Luminance calibration tools	Integrated optical sensorExternal optical sensorCalibration software:RadiCS	Integrated optical sensorExternal optical sensorCalibration software:RadiCS
Quality-control procedures
	Software: RadiCS	Software: RadiCS

It is clear that the technological characteristics differences discussed above do not affect the safety and the effectiveness of the RX370.

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7. Performance Testing

The bench tests below were performed on the RadiForce RX370 following the instructions in "Guidance for Industry and FDA Staff: Display Devices for Diagnostic Radiology" issued on October 2, 2017:

. 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 pixel aperture ratio
Measurement of Color tracking .

The test results showed that the RadiForce RX370 has display characteristics equivalent to those of the predicate device, RadiForce RX360.

Besides, the display characteristics of the RadiForce RX370 meet the pre-defined criteria when criteria are set.

No animal or clinical testing was performed on the RadiForce RX370.

8. Conclusion

The RadiForce RX370 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).