RadiForce G22 is a monitor for medical use. G22 provides 2 mega pixel (1200 x 1600) readly of or and 10 bit (1,024 tones) simultaneous grayscale display for accurate diagnosis in CT, DSA, and MRI, etc, except for a digital mammography system.

AI/ML Overview

Device Acceptance Criteria and Performance Study: EIZO RadiForce G22 Monochrome LCD Monitor

This document describes the acceptance criteria and the supporting information for the EIZO RadiForce G22 Monochrome LCD Monitor, as presented in its 510(k) submission (K041597).

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the RadiForce G22 are implicitly defined by demonstrating substantial equivalence to the predicate device, the EIZO FC-2091 Monochrome LCD Monitor (K022109). The comparison focuses on key technological characteristics. The "Reported Device Performance" column reflects the specifications of the RadiForce G22.

Characteristic	Acceptance Criteria (Predicate: FC-2091)	Reported Device Performance (RadiForce G22)
Panel Size and Type	53 cm (20.8") TFT monochrome LCD panel	19.6" Class Monochrome LCD Monitor
Pixel Pitch	0.207 mm x 0.207 mm	0.294 mm x 0.294 mm
Display Colors	1.531 grayscale tones	1,024 million grayscale tones from a pallet of 3,061
Native Resolutions	2048 mm x 1536 mm (landscape), 1536 mm x 2048 mm (portrait)	1200 mm x 1600 mm
Brightness	650 cd/m²	800 cd/m²
Contrast Ratio	600 : 1 (typical)	600 : 1 (typical)
Response Time	50 ms (typical)	40 ms (typical)
Input Signals	DVI Standard 1.0	DVI Standard 1.0
Input Terminals	DVI-D 24 pin	DVI-D 24 pin
USB Ports / Standard	1 upstream, 2 downstream / Rev. 1.1	1 upstream, 2 downstream / Rev. 2.0
Luminance Calibration	Software (Optional), Photo-sensor (Optional)	Software (Optional), Photo-sensor (Optional)
Intended Use	Displaying for diagnosis in CT, DSA, and MRI, etc., except for a digital mammography system.	Displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system.
Compliance Standards	TUV/GM, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-A, Canadian ICES-003-A, VCCI-A, FDA 510(k)	TUV/GM, CE Medical Device Directive, CB (EN60601-1), cTUVus (UL2601-1, CSA C22.2 No. 601-1), FCC-B, Canadian ICES-003-A, VCCI-A, EIZO ECO Products 2002

Note: The differences in Pixel Pitch, Native Resolutions, Brightness, and Response Time for the G22 are considered to be within acceptable performance for the stated intended use and are not described as deviations requiring additional clinical testing. The updated compliance standards (e.g., CE Medical Device Directive) also reflect current requirements at the time of submission.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary for the EIZO RadiForce G22 is for a monochrome LCD monitor, which is a hardware device. The equivalence is established through a technical comparison to a predicate device and compliance with relevant performance and safety standards.

Sample Size for Test Set: Not applicable. For hardware devices like monitors, performance is typically evaluated through engineering tests, adherence to technical specifications, and compliance with industry standards, rather than a "test set" of patient data in the way an AI algorithm would be evaluated. The "test set" in this context refers to the monitor unit itself and its performance characteristics.
Data Provenance: Not applicable in the context of clinical data. The data provenance would relate to the technical specifications and test results conducted by the manufacturer, which are assumed to be generated in Japan (country of origin for EIZO NANAO CORPORATION). The assessment is based on physical and electrical characteristics of the monitor.
Retrospective or Prospective: Not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. As this is a hardware device (monitor), there is no "ground truth" derived from expert interpretation of medical images in the same way as an AI diagnostic algorithm. The "ground truth" for a monitor's performance is its technical specifications (e.g., brightness, contrast, resolution, grayscale tones) being met and verified through objective measurements and calibration, often against industry standards.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication of medical image interpretations as this is not an AI diagnostic device. The performance validation for a monitor involves engineering measurements and evaluations against established technical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. An MRMC study is designed to assess the impact of a diagnostic aid (often AI) on human reader performance when interpreting medical cases. This device is a display monitor, not a diagnostic aid or AI algorithm.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a display monitor, not an algorithm. Its function is to accurately render images for human interpretation, not to make independent diagnoses.

7. Type of Ground Truth Used

The "ground truth" for the EIZO RadiForce G22 monitor is based on its technical specifications and performance characteristics. This includes:

Objective Measurements: Brightness (cd/m²), Contrast Ratio, Pixel Pitch, Response Time, Native Resolutions, Grayscale Tones.
Compliance with Standards: Adherence to international and national standards for medical display devices (e.g., DIN 6868-57, AAPM TG18, IEC 60601-1, FCC, CE Medical Device Directive, etc.), which ensure image quality, safety, and performance for medical use. The 510(k) mentions compliance with various standards (TUV/GM, CE, CB, EN60601-1, UL2601-1, CSA C22.2 No. 601-1, FCC-B, Canadian ICES-003-A, VCCI-A).

The comparison with the predicate device (FC-2091) serves as the basis for demonstrating substantial equivalence against an already cleared device with established "ground truth" performance for medical imaging display.

8. Sample Size for the Training Set

Not applicable. This is a hardware device (monitor), not an AI algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no AI algorithm and therefore no "training set," this question is not relevant.

Summary

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K041597

JUN 2 4 2004

510(k) Summary as required by 807.92

1. Company Identification

EIZO NANAO CORPORATION E120 NANAO OOILI Ola1110.shi, Ishikawarken, 924.8566, Japan Tel: +81-76-274-2468 Fax: +81-76-274-2484

1. Official Correspondent
  Hiroaki Hashimoto (Mr.)

3. Date of Submission

June 8, 2004

1. Device Trade name
  Monochrome LCD Monitor, RadiForce G22

5. Common Name

Monitor, display, workstation, and others

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

7. Predicate Device

: EIZO NANAO CORPORATION Manufacturer : 20.8" Monochrome LCD Monitor Device Name : FC-2091 Model Name : K022109 510(k) No.

8. Description of Device

G22 provides 2 mega pixel (1200 x 1600) RadiForce G22 is a monitor for medical use. readly of or and 10 bit (1,024 tones) simultaneous grayscale display for accurate diagnosis in CT, DSA, and MRI, etc, except for a digital mammography system.

1. Intended Use
  Mooochrome LCD Monitor, RadiForce G22 is intended to be used in displaying for diagnosis of in CT, DSA, and MRI, etc. These intended usages are same as that of the predicate model of FC2091, K022109.
1. Comparison of technological characteristics between new device and predicate device Please refer to Appendix 1.
1. Compliance standards Please refer to Appendix 1.

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Items	FC-2091	G22
510(k) Number	K022109	Not known
Panel Size and Type	53 cm (20.8") TFT monochrome LCD panel	19.6" Class Monochrome LCD Monitor
Pixel Pitch	0.207 mm x 0.207 mm	0.294 mm x 0.294 mm
Available Cabinet Colors	Black	Black, Gray
Display Colors	1.531 grayscale tones	1,024 million grayscale tones from a pallet of 3,061
Viewing Angles	H: 170°, V: 170°	H: 170°, V: 170°
Scanning Frequency (H, V)	92.86 - 96.72 Hz, 60 Hz	75 kHz, 60 Hz
Native Resolutions	2048 mm x 1536 mm (landscape),1536 mm x 2048 mm (portrait)	1200 mm x 1600 mm
Brightness	650 cd/m²	800 cd/m²
Contrast Ratio	600 : 1 (typical)	600 : 1 (typical)
DOT Clock	132MHz	162 MHz
Response Time	50 ms (typical)	40 ms (typical)
Input Signals	DVI Standard 1.0	DVI Standard 1.0
Input Terminals	DVI-D 24 pin	DVI-D 24 pin
USB Ports / Standard	1 upstream, 2 downstream / Rev. 1.1	1 upstream, 2 downstream / Rev. 2.0
Active Display Size (H x V)	424 mm x 318 mm	398 mm x 299 mm
Viewable Image Size	529 mm (20.8") (diagonal)	498 mm (diagonal)
Luminance Calibration	Software (Optional)Photo-sensor (Optional)	Software (Optional)Photo-sensor (Optional)
Power	AC100-120V/200-240V, 50/60Hz	AC100-120V/200-240V, 50/60Hz
Power Management	DVI-DMPM	DVI-DMPM
Power Consumption	70 watts (typical)	70 watts (typical)
Power Save Mode	Less than 15 watts	Less than 6 watts
Dimensions (W x H x D)	With Stand:368 x 520 mm – 592 x 209 mmWithout Stand:368 mm x 474 mm x 84 mm	With Stand:337 x 493 mm – 575 x 208.5 mmWithout Stand:337 mm x 441 mm x 78.5 mm
NET Weight	With Stand: 9.5 kgWithout Stand: 6.3 kg	With Stand: 9.1 kgWithout Stand: 5.9 kg
Certifications & Standards	TUV/GM, CE, CB, EN60601-1,UL2601-1, CSA C22.2 No. 601-1,FCC-A, Canadian ICES-003-A,VCCI-A, FDA 510(k)	TUV/GM, CE Medical Device Directive, CB (EN60601-1), cTUVus(UL2601-1, CSA C22.2 No. 601-1),FCC-B, Canadian ICES-003-A,VCCI-A, EIZO ECO Products 2002

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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 stylized eagle with three bars representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 4 2004

Mr. Hiroaki Hashimoto Manager of Engineering Management Section EIZO NANAO Corporation 153 Shimokashiwano, Matto, Ishikawa 924-8566 JAPAN

Re: K041597 Trade/Device Name: Monochrome LCD Monitor, RadiForce G22 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 8, 2004 Received: June 14, 2004

Dear Mr. Hashimoto:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Scenon > Po(x) promation is substantially equivalent (for the indications relerenced above and nave determined in marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manage of the Medical Device American be of Days commerce phor to May 20, 1976, the closener with the provisions of the Federal Food, DNA devices that have been resulted in assoredance approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require approvise the general controls provisions of the Act. The You may, therefore, market the device, easy of every of ennual registration, listing of general controls provisions of the rice 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 If your device is classified (soo aoore) ins. Existing major regulations affecting your device can may be subject to such additional och. One - Little 21, Parts 800 to 898. In addition, FDA may oc found in the OOGS acements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a cases in the ther requirements of the Act that FDA hade a decemmation that your cover correst by other Federal agencies. You must comply
of any Federal statutes and regulations administered by other Federal and CEP P or any Federal statutes and regalations administration and listing (21 CFR Part with an the Act s requirements, meracting practice requirements as set forth in the 807), labeling (21 CFR Part 820); and if applicable, the electronic product
quality systems (QS) regulation (21 CFR Part 820); and if application (2006) 1950 quality systems (QB) regardice (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) I ms letter will anow you to ocgin manioung your device of your device of your device to a legally premarket notincation: "The PDF intellig sification 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 If you desire specific advice to: your General 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 Additionally, 10. questions on and please note the regulation entitled, "Misbranding Other of Comphanoour (2017 07 1 33 (21 CFR Part 807.97) you may obtain. Other general by receice to premarred notified.out (er the Act may be obtained from the Division of Small mormation on your responsionner Assistance at its toll-free number (800) 638-2041 or 11andraocarers, 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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Indications for Use

K041597

510(k) Number (if known): Not-known

Device Name: Monochrome LCD Monitor, RadiForce G22

Indications For Use:

finaletterns 1 0 - 2 - 11:11
RadiForce G22 is intended to be used in displaying for diagnosis in CT, DSA, or MRI, etc., except for a digital mammography system.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Lyman

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).