RadiForce G20 is 20.1 inches monochrome monitor for medical use. This model has specification of resolution in 1600 x 1200 or 1200 x 1600 and is certified for IEC60601-1 of medical safety standard.

AI/ML Overview

This document is a 510(k) summary for a medical display monitor (EIZO RadiForce G20), indicating it is a hardware device. The questions provided are typically for AI/software devices. This device is a monitor, which is a display hardware, and therefore the concepts of "acceptance criteria for an algorithm", "sample size for test/training set", "ground truth", "experts", "MRMC study", and "standalone performance" do not directly or entirely apply in the same way they would for a diagnostic AI algorithm.

However, I will interpret the request to provide the closest applicable information based on the provided text, focusing on how the device's technical specifications demonstrate its suitability for medical imaging display.

Here's an analysis based on the provided text:

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

Since this is a hardware device (a monitor), "acceptance criteria" are typically defined by its technical specifications and compliance with relevant medical standards, and "reported device performance" refers to how the device meets those specifications. The provided document details the specifications of the new device (G20) and compares them to a predicate device (FC-2091).

The study proves the device meets the acceptance criteria by demonstrating that its technical specifications are either equivalent to or improved compared to a predicate device (EIZO FC-2091), which has already received 510(k) clearance for medical use. The critical point is that these specifications, coupled with compliance to medical safety and EMI/EMC standards (like EN60601-1), ensure the device is suitable for its intended use in displaying X-ray or MRI images for diagnosis.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This device is a hardware monitor, not an AI algorithm that processes data. Therefore, there is no "test set" in the sense of a dataset of medical images, nor is there "data provenance" (country of origin, retrospective/prospective). The "test" for a monitor involves engineering verification and validation of its physical and performance characteristics (e.g., brightness, contrast, resolution, compliance with electrical safety standards, electromagnetic compatibility). These tests are typically conducted in a laboratory setting by the manufacturer as part of their quality management system.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Again, this is not applicable to a medical display monitor in the way it applies to an AI algorithm. There is no "ground truth" to establish from medical images using expert readers for the monitor itself. The "ground truth" for a monitor's performance is objective technical measurement against its specifications and industry standards. For example, brightness is measured with a photometer, and resolution is verified against display drivers.

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

Not applicable. This concept pertains to establishing consensus ground truth among multiple human readers for an AI algorithm's test set. A medical display monitor does not involve such an adjudication process for its own performance evaluation.

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. An MRMC study is used to assess the impact of an AI algorithm on human reader performance for diagnostic tasks. This device is a display monitor; its function is to render images, not to provide diagnostic assistance via AI.

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

Not applicable. A "standalone" performance evaluation refers to an AI algorithm's diagnostic accuracy without human interaction. This device is a passive display unit.

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

Not applicable in the context of diagnostic AI. For a monitor, the "ground truth" is its physical and performance specifications as measured by engineering and quality assurance tests. These include measurements of luminance, contrast, uniformity, color accuracy (for color displays, though this is a monochrome monitor), pixel defects, viewing angles, and compliance with electrical, safety, and EMC standards.

8. The sample size for the training set

Not applicable. This device is hardware; it does not employ machine learning or require a "training set."

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

Not applicable (as above).

Summary

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510(k) Summary as required by 807.92

1. Company Identification

K030347

EIZO NANAO CORPORATION 153 Shimokashiwano-cho, Matto-shi, Ishikawa-ken, 924-8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484

2. Official Correspondent

Hiroaki Hashimoto (Mr.)

3. Date of Submission

January 27, 2003

4. Device Trade name

20.1" Monochrome LCD Monitor, RadiForce G20

5. Common Name

Monitor, display, workstation, and others

6. Classification

Medical displays were classified in Class II per 21 CFR 890.2050.

7. Predicate Device

20.8" Monochrome LCD Monitor, FC-2091 manufactured by EIZO NANAO CORPORATION

8. Description of Device

RadiForce G20 is 20.1 inches monochrome monitor for medical use. This model has specification of resolution in 1600 x 1200 or 1200 x 1600 and is certified for IEC60601-1 of medical safety standard.

9. Intended Use

20.1" Monochrome LCD Monitor, RadiForce G20 is intended to be used in displaying for diagnosis of X-ray or MRI.

1. Comparison of technological characteristics between new device and predicate device Please refer to Attachment 1.
1. Compliance standards Plaaco rafar to Attachmont 1

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Appendix 1: Comparison table with predicate device

Items	FC-2091	G20
510(k) Number	K022109
Panel Size and Type	53 cm (20.8") TFT monochrome LCD panel	51 cm (20.1") TFT monochrome LCD panel
Pixel Pitch	0.207 mm x 0.207 mm	0.255 mm x 0.255 mm
Available Cabinet Colors	Black	Black
Display Colors	1.531 grayscale tones	1.531 grayscale tones
Viewing Angles	H: 170°, V: 170°	H: 170°, V: 170°
Scanning Frequency (H, V)	92.86 - 96.72Hz, 60Hz	Digital: 31.5 kHz – 75kHz, 60 Hz (VGA Text: 70Hz)
Native Resolutions	2048 x 1536 (landscape),1536 x 2048 (portrait)	1600 x 1200 (landscape),1200 x 1600 (portrait)
Brightness	650 cd/m²	700 cd/m²
Contrast Ratio	600 : 1 (typical)	1000 : 1 (typical)
DOT Clock	132MHz	Digital: 162MHz
Response Time	50 ms (typical)	30 ms (typical)
Input Signals	DVI Standard 1.0	DVI Standard 1.0
Input Terminals	DVI-D 24 pin	DVI-D 29 pin
USB Ports / Standard	1 upstream, 2 downstream / Rev. 1.1	1 upstream, 2 downstream / Rev. 1.1
Serial Ports	D-Sub 9 pin (Remote Out),Min DIN 6 pin (Remote In)Min DIN 8 pin (Photo Sensor)	D-Sub 9 pin (Remote Out),Mini DIN 6 pin (Remote In)Mini DIN 8 pin (Photo Sensor)
Active Display Size (H x V)	424 mm x 318 mm(16.7" x 12.5")	408 mm x 306 mm(16.1" x 12.0")
Viewable Image Size	529 mm (20.8") (diagonal)	510 mm (20.1") (diagonal)
Power	10V-120V/200V-240V, 50/60Hz, 0.7A-0.4A, 0.4-0.2A	10V-120V/200V-240V, 50/60Hz, 0.65A-0.4A, 0.35A-0.2A
Power Management	DVI-DMPM	DVI-DMPM
Power Consumption	70 watts (typical)	55 watts (typical)
Power Save Mode	Less than 15 watts	Less than 8 watts
Dimensions (W x H x D)	With Stand:368 mm x 520 – 592mm x 209 mm(14.5" x 20.5" x 23.3" x 8.2")Without Stand:368 mm x 474 mm x 84 mm(14.5" x 20.5" x 23.3" x 8.2")	With Stand:449 mm x 456 – 528 mm x 209 mm(17.7" x 18.0" x 20.8" x 8.2")Without Stand:449 mm x 347 mm x 86.5 mm(17.7" x 13.7" x 3.4")
NET Weight	With Stand: 9.5 kg (20.9 lbs),Without Stand: 6.3 kg (13.9 lbs)	With Stand: 10.5 kg (23.1 lbs),Without Stand: 7.3 kg (16.1lbs)
Certifications & Standards	TUV/GM, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, Canadian ICES-003-A,	TUV/GM, c-TUV, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, Canadian ICES-003-A,
	VCCI-A, FDA 510(k)	TUV/S, VCCI-A

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2003

Eizo Nanao Corportaion % Mr. Akira Wakayama Safety Department Cosmos Corporation 319 Akeno, Obata-cho Watarai-gun, Mie-ken 519-05, JAPAN

Re: K030347

Trade/Device Name: 20.1" Monochrome LCD Monitor, RadiForce G20 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: January 29, 2003 Received: February 3, 2003

Dear Mr. Wakayama:

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.

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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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January 27, 2003

STATEMENT OF INDICATIONS FOR USE

KU3034 510(k) Number (If known):

Device Name: 20.1" Monochrome LCD Monitor

Indications for Use:

20.1" Monochrome LCD Monitor, RadiForce G20 is intended to be used in displaying for diagnosis of X-ray or MRI.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / OR Over-The-Counter Use

(Optional Format 1-2-96)

510(k) Number

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).