FC-2091 is 20.8 inches class monochrome LCD monitor for medical use. This monitor is usually used to display for X-ray diagnosis or MRI. such as one of the medical diagnosis system. This model has specification of resolution in 2048 × 1536 or 2048 × 1536 . And this model has the USB function and optional photo-sensor DTP92 made by X rite Incorporated. This model is certified IEC60601-1 for medical safety standard.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the EIZO FC-2091 monochrome LCD monitor:

Based on the provided 510(k) summary, the device is a medical display monitor. The submission is for a display monitor, not an AI-powered diagnostic device, so many of the requested fields related to AI performance, ground truth, and expert evaluation are not applicable. The primary "acceptance criteria" for such a device would relate to its technical specifications and demonstration of substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

For a medical display monitor like the FC-2091, the "acceptance criteria" are typically met by demonstrating technical specifications comparable to or better than a legally marketed predicate device, and compliance with relevant safety and performance standards. The study implicitly proving this is the technical comparison and demonstration of compliance found in the 510(k) submission.

Acceptance Criteria (Implied from comparison with Predicate)	Reported Device Performance (FC-2091)
Resolution: Comparable to predicate.	2048 x 1536 or 1536 x 2048 (Same as predicate ME311L)
Display Area: Comparable to predicate.	423.9mm x 318mm (Same as predicate ME311L)
Gray-scale Display: Adequate for diagnostic imaging.	1531 tones (10.5bit), in accordance with DICOM Part 14 (Superior to predicate ME311L's 1021 tones)
Luminance: Adequate for diagnostic imaging.	Max. 650[cd/m²] (Superior to predicate ME311L's 600[cd/m²] or more)
Luminance Calibration: Feature for calibration.	Software (Option), Photo-sensor (Option) [model DTP92:X-rite] (Comparable to predicate ME311L)
Safety Standards Compliance: Meeting medical safety.	IEC60601-1, UL2601-1, CSA No.601-1, MDD/CE (EN60601-1/EN60601-1-2), FCC class A, VCCI class A (Comparable to predicate ME311L)
Intended Use: Display for diagnosis of X-ray or MRI.	Intended to use in displaying for diagnosis of X-ray or MRI etc. (Identical to predicate's implicit intended use for a monitor)
Basic Structure: LCD display and stand, portrait mode.	Basic structure of LCD display and stand, capable of portrait mode. (Comparable to predicate ME311L)

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

Sample Size: Not applicable in the context of a diagnostic performance study. The "test set" here refers to the physical device undergoing technical evaluation against specifications. There isn't a "data set" of medical images being evaluated.
Data Provenance: Not applicable. The evaluation is of the monitor's technical specifications and compliance with standards rather than its performance with patient data.

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

Not applicable. As this is hardware, ground truth is established through physical measurements, engineering specifications, and compliance with established standards, not through expert consensus on medical images.

4. Adjudication Method for the Test Set:

Not applicable. There is no qualitative assessment by experts requiring adjudication.

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. This is a medical display monitor, not an AI-powered diagnostic tool. There is no AI component.

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

Not applicable. This is a display monitor, not an algorithm.

7. The Type of Ground Truth Used:

Technical Specifications and Compliance Documents: The "ground truth" for a medical display is its adherence to published technical specifications (e.g., resolution, luminance, grayscale tones) and compliance with international and national safety and performance standards (e.g., DICOM Part 14 for grayscale rendering, IEC 60601-1 for medical safety). This is demonstrated through engineering tests and documentation.

8. The Sample Size for the Training Set:

Not applicable. This is a medical display monitor, not a machine learning model; therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set for a medical display monitor.

Summary

{0}------------------------------------------------

JUL 12 2002

10. 510(k) Summary

。

参考文献

KO22109

as required by 807.92

1. Company Identification
  Submitter name : EIZO NANAO CORPORATION Address : 153. Shimokashiwano. Matto. Ishikawa. 924-8566. Japan Tel :481-76-274-2468 :+81-76-274-2484 Fax
1. Official Correspondent
  Hiroaki Hashimoto (Mr.) Manager, engineering management section
Date of Submission న్న
February 4. 2002
1. Device trade name
  20.8 inch class monochrome LCD monitor
1. Common name
  Monitor
1. Classification
  Medical displays were classified in class II (21 CFR 890.2050)

Intended use The FC-2091 monochrome LCD monitor is intended to use in displaying for diagnosis of X-rav or MRI etc.
Predicate Device

Manufacturer: Totoku Electric Co.. Ltd. MONOCHROME PERFECTLY FLAT PANEL DISPLAYS Device name: ME311L:510(k) No.: K012099) Model name : Gray scale tones: 1021tones

1. Comparison of technological characteristics between new device and predicate device
  Please refer to the attachment Appendix.3.

{1}------------------------------------------------

Appendix. 3

Comparison table with predicate device

Item	FC-2091 (EIZO)	ME311L (Totoku)
510(k) number		K012099
Technological characteristics
LCD inches	20.8 inches	20.8 inches
LCD surface	AG coating	AG coating
Display area	423.9mm x 318mm	423.9mm x 318mm
Input signal(Digital)	TMDS(Single Link)	GVTF(10214-1210VE)
Screen resolution	2048 x 1536 or1536 x 2048	2048 x 1536 or1536 x 2048
Gray-scale display	1531 tones (10.5bit)(In accordance with DICOMPart 14)	1021 tones
Luminance	Max.650[cd/m²]	600[cd/m²] or more
Luminance calibration	•Software (Option)•Photo-sensor (Option)[model DTP92:X-rite]• Protection panel (Option)	•Software (Option)•Photo-sensor (Option)[model DTP92:X-rite]•Photo-sensor holder(Option)
Connector	DVI-D x1USB 1up. 2downSerial (mini DIN 6pin)Serial (D-sub 9pin)Sensor serial port:(mini DIN 8pin)	D-sub (9pin) x2USB 1up. 2down
Dimensions(W x H x D [mm])	474 x 368 x 84[mm](Approx.)	486 x 480 x 250[mm](Approx.)
Weight [kg]	9.5kg	11kg
Power	AC 100-120V/200-240V50/60Hz Max. 95W	AC100-240V 50/60HzNormally approx. 70W
Complied Standard	IEC60601-1UL2601-1CSA No.601-1MDD/CE(EN60601-1/EN60601-1-2)FCC class AVCCI class A	Safety:IEC60601-1UL2601-1CSA No.601-1MDD/CE (EN60601-1)FDA510(k)EMC:FCC class AVCCI class ABSMI (CNS13438/C6357)

Eizo's FC-2091 is different compared to a predicate device. Totoku ME311L in difference of built-in circuit of power supply instead of AC adapter. Looking at two models' outside. the shape of stand and connector and the number of connectors. However, the basic structure of the both models are the same in terms of consisting of LCD display and stand, and they are capable for use in portrait mode.

Totoku ME311L adopts GVIF for transmission method for digital video signal but Eizo FC-2091 adopts TMDS method. Eizo's FC-2091 has specification of resolution in 2048[H]× 15:36[V] in landscape mode or 15:36[H]×2048[V] in portrait mode.

Eizo FC-2091 converts inputted 8bit video signal into 10,5bit by mean of its ASIC, and this results in displaying maximum of 1531 scales while Totoku ME311L only displays 1021 scales. Eizo's FC-2091 1s able to display grayscale tones that is based on DICOM part14.

{2}------------------------------------------------

10. Description Device

FC-2091 is 20.8 inches class monochrome LCD monitor for medical use.

This monitor is usually used to display for X-ray diagnosis or MRI. such as one of the medical diagnosis system. This model has specification of resolution in 2048 × 1536 or 2048 × 1536 . And this model has the USB function and optional photo-sensor DTP92 made by X rite Incorporated. This model is certified IEC60601-1 for medical safety standard.

Optional digital video card was designed exclusively for FC-2091. Type of digital video card is VR Engine MD3 by RealVision Inc. This video card for FC-2091 is sold separately. but FC-2091 support the digital video signal for only VR Engine MD3.

{3}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing to the right, arranged in a stacked formation. The profiles are abstract and created with thick, curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top half of the image.

(JUL 12 2002

Eizo Nanao Corp. % Mr. Wolfram Gmelin Technical Manager TÜV Rheinland of North America 12 Commerce Road NEWTON CT 06470

Re: K022109

Trade/Device Name: 20.8 inch monochrome LCD monitor (Model FC-2091) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 20, 2002 Received: June 28, 2002

Dear Mr. Gmelin:

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 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 this letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4610
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" (21 CFR Part 807.97). 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. Snogdon

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

Enclosure

{5}------------------------------------------------

. 1

STATEMENT OF INTENDED USE

510(k) Number (if known): Device Name:_20.8 inch Monochrome LCD Monitor

Indications for Use:

The FC-2091 monochrome LCD monitor 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

David A. Beeson

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 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).