The provided text describes a 510(k) submission for a medical monitor and does not contain information about acceptance criteria or a study proving its performance against such criteria. The submission is a premarket notification for a new medical device, the IIYAMA CORPORATION 51cm (20.1 inch) TFT Monochrome LCD Monitor (MU5111BW), seeking substantial equivalence to a predicate device, the EIZO NANAO RadiForce G21 (K024358).

Therefore, I cannot provide the requested information about acceptance criteria or a study because the provided text does not contain this information.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting performance metrics against specific acceptance criteria from a primary clinical or technical study, as would be expected for a novel AI/software device or a device with new performance claims.

The comparison in the document is primarily a feature-by-feature comparison of technical specifications between the proposed device and the predicate device to argue for substantial equivalence in design and intended use. Performance testing, if conducted, would typically be to ensure the device meets its own specifications (e.g., brightness, contrast, resolution) which are then compared to the predicate, but specific "acceptance criteria" and a "study proving it meets them" in the context of clinical performance (like diagnostic accuracy) are not detailed here.

Summary

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- 2 2003

510(k) Summary as required by 807.92

Company Identification

IIYAMA CORPORATION 710-1 Kitaowaribe, Nagano city, Nagano Pref. 381-0014, Japan TEL: +81-26-263-5114 FAX: +81-26-263-5124

Official Correspondent

Kazuyoshi Tateiwa (Mr.) / Deputy Group Manager Visual-Media Control Division Technical Support Group Technical No. 2 Dept.

3. Date of Submission

June 26, 2003

1. Device Trade name
  51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW

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

Manufacturer	: EIZO NANAO CORPORATION
Device Name	: 20.1" Monochrome LCD Monitor
Model Name	: RadiForce G21
510(k) No.	: K024358
Items	G21	MU5111BW
510(k) Number	K024358
Panel Size and Type	51 cm (20.1") TFT monochrome LCD panel	51cm(20.1") TFT monochrome LCD panel
Pixel Pitch	0.255 mm x 0.255 mm	0.255mm x 0.255mm
Available Cabinet Colors	Black	Black
Display Colors	1,531 grayscale tones	Maximum 256-level monochrome
Viewing Angles	H: 170°, V: 170°	H: 170°, V: 170°
Scanning Frequency (H, V)	Analog: 31.5 kHz – 130kHz,50 kHz – 85kHzDigital: 31.5 kHz - 75kHz,60 Hz (VGA Text: 70Hz)	fH: 24.0-80.0kHz,fv : 56-85Hz
Native Resolution	1600 x 1200 (landscape),1200 x 1600 (portrait)	1600 x1200 (Landscape)1200 x1600 (Portrait)
Brightness	700 cd/m²	700cd/m²(Typical)
Contrast Ratio	1000: 1 (Typical)	1000: 1 (Typical)
DOT Clock	Analog: 240MHzDigital: 162MHz	Digital: 162MHz
Response Time	30 ms (typical)	25ms
Input Signals	RGB Analog,DVI Standard 1.0	Analog: 0.7Vp-p(Standard), 75Ω PositiveDigital: DVI Standard Rev.1.0
Input Terminals	DVI-D 29 pin,BNC	DVI-I 29pin
USB Ports / Standard	1 upstream, 2 downstream / Rev. 1.1	1upstream, 4downstream, Rev. 2.0/1.0
Serial Ports	D-Sub 9 pin (Remote Out),Min DIN 6 pin (Remote In)Mini DIN 8 pin (Photo Sensor)	Not provided.
Active Display Size (H, V)	408 mm x 306 mm(16.1" x 12.0")	408 mm x 306 mm(16.1" x 12.0")
Viewable Image Size	510 mm (20.1") (diagonal)	510mm (20.1") (diagonal)
Power Management	VESA DPMSDVI-DMPM	VESA DPMS
Power Consumption	55 watts (typical)	70 watts maximum
Power Save Mode	Less than 8 watts	Less than 5 watts
Dimensions (W x H x D)	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")	466 x 424 – 534 x 241 mm / 18.3×16.7-21×9.5"
Luminance Calibration	Software (Standard)Photo-sensor (Standard)Protection panel (Standard)	No calibration software used.Auto adjustment function provided.
Power	10V-120V/200V-240V, 50/60Hz,0.65A-0.4A, 0.35A-0.2A	100-230VAC, 50/60Hz 0.7-0.35A
NET Weight	With Stand: 10.5 kg (23.1 lbs),Without Stand: 7.3 kg (16.1lbs)	10kg / 22lbs
Certification & Standards	TUV/GM, c-TUV, CE, CB, EN60601-1,UL2601-1, CSA C22.2 No. 601-1, FCC-A,	Under applications forUL / C-UL, TUV-GS, CB,

8. Description of Device

51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is a display for medical use.

9. Intended Use

51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X ray or MRI and others application for medical. This is the same intended use for the previously cleared for RadiForce G21, K024358.

10. Compliance standards

Please refer to Appendix 1.

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Appendix 1: Comparison Table with Predicate Device

Comparing to a predicate device, EIZO NANAO RadiForce 21, Iiyama's MU5111BW has only a ● few differences. MU5111BW does not have serial ports, and automatic adjustment function provided. However, the basic structure of both models is the same in terms of LCD display with stand and its functions.

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Image /page/2/Picture/1 description: The image shows a logo with a stylized bird inside a circle. The bird is composed of three curved lines that suggest wings and a body. The circle surrounding the bird is made up of small, indistinct shapes, possibly letters or symbols. The logo is black and white and appears to be a simple, graphic design.

ood and Drug Administration 0 Corporate Boulevard Rockville MD 20850

SEP - 2 2003

Mr. Kazuyoshi Tateiwa Deputy Group Manager Ilyama Corporation 710-1 Kitaowaribe, Nagano City, Nagano Pref., 381-0014 JAPAN

Re: K032020

Trade/Device Name: 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system

Regulatory Class: II Product Code: 90 LLZ Dated: June 27, 2003 Received: July 10, 2003

Dear Mr. Tateiwa:

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

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INDICAITIONS FOR USE STATEMENT

KO3 2020 510(k) Number (If known):

Device Name: 51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW

Indications for Use:

51cm (20.1 inch) TFT Monochrome LCD Monitor, MU5111BW is intended to be used in displaying for diagnosis of X-ray or MRI, etc.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson

and Ra 510(k) Numb

Prescription Use (Per 21CFR 801.109)

Over The Counter Use_

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).