This 510(k) summary describes a medical device, the EIZO NANAO RadiForce G21 monitor, but it does not contain any information about acceptance criteria or a study proving that the device meets those criteria.

This document is a 510(k) notification, which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. The information provided focuses on device description, intended use, and substantial equivalence to a predicate device, rather than performance evaluation studies.

Therefore, I cannot fulfill your request for the specific acceptance criteria and study details based on the provided text.

The closest relevant information is a comparison table between the new device (G21) and its predicate (FC-2091), which outlines various technical specifications. This implies that the acceptance criteria for the G21 would be to meet or exceed the performance of the predicate device based on these specifications. However, no formal acceptance criteria table or performance study results are presented.

Here's a breakdown of why I cannot answer your specific questions with the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The text only includes a comparison table of specifications between the proposed device and a predicate device.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided. No test set or data provenance is mentioned.
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): Not provided. There is no mention of a test set or ground truth established by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 and not provided. This device is a monitor, not an AI algorithm.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable and not provided. This device is a monitor, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
The sample size for the training set: Not applicable and not provided. This device is a monitor, not an AI algorithm that requires a training set.
How the ground truth for the training set was established: Not applicable and not provided.

The document serves as regulatory submission highlighting equivalence to a previously cleared device, not a performance study report.

Summary

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K02 4358

510(k) Summary as required by 807.92

MAR 2 5 2003

1. Company Identification

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

December 26, 2002

4. Device Trade name

20.1" Monochrome LCD Monitor, RadiForce G21

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

20.1" Monochrome LCD Monitor, RadiForce G21 is a display for medical use. This product complies with radiation performance standards.

9. Intended Use

20.1" Monochrome LCD Monitor, RadiForce G21 is intended to be used in displaying for diagnosis of X ray or MRI, etc.

10. Compliance standards

Please refer to Appendix 1.

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Appendix 1: Comparison Table with Predicate Device

Items	FC-2091	G21
510(k) Number	K022109	Not known
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	Analog: 31.5 kHz - 130kHz,50 kHz - 85kHzDigital: 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	Analog: 240MHzDigital: 162MHz
Response Time	50 ms (typical)	30 ms (typical)
Input Signals	DVI Standard 1.0	RGB Analog,DVI Standard 1.0
Input Terminals	DVI-D 24 pin	DVI-D 29 pin, BNC
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),Min 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 Management	DVI-DMPM	VESA DPMS, 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 18.7" x 3.3")	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,

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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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EIZO NANAO Corporation % Mr. Akira Wakayama Safety Dept. Cosmos Corporation 319 Akeno, Obata-cho Watarai-gun, Mie-ken, 519-05 JAPAN

MAR 2 5 2003

Re: K024358 Trade/Device Name: 20.1" Monochrome LCD Monitor, RadiForce G21 Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 26, 2002 Received: December 30, 2002

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 vours.

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

Page 2

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STATEMENT OF INDICATIONS FOR USE

510(k) Number (If known): _Kø 2 43 5 8

Device Name: 20.1" Monochrome LCD Monitor

Indications for Use:

20.1" Monochrome LCD Monitor, RadiForce G21 is intended to use in displaying for diagnosis of X-ray or MRI etc.

(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)

Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K024358

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).