Medical Display, MD211G3 is a 21.3" Monochrome LCD monitor that displays image for medical use. It provides 3 mega pixel (2048*1536) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the NEC MD211G3 medical display, based on the provided text:

Acceptance Criteria and Device Performance (Table)

The device, MD211G3, is a medical LCD monitor. The primary "acceptance criteria" discussed are its performance specifications, which are benchmarked against those of its predicate device, the L218TL. The study aims to demonstrate substantial equivalence by meeting these comparable specifications.

Acceptance Criteria (Predicate: L218TL)	Reported Device Performance (MD211G3)
Panel Size and Type: 21.3" TFT Monochrome LCD Monitor	21.3" TFT Monochrome LCD Monitor
Pixel Pitch: 0.212 mm x 0.212mm	0.212 mm x 0.212mm
Display Monochromes: 10-bit (1024 grey tones) with 3061 total colors	10-bit (1024 grey tones) with 3061 total colors
Viewing Angles (°) : H:176, V:176	H:176, V:176
Scanning Frequency (H, V): 31.5-95.4kHz, 30-85 Hz	31.5-95.4kHz, 30-85 Hz
Native Resolutions: 2048X1536	2048X1536
Brightness: 400 cd/m² calibrated, 1450 cd/m² Max.	400 cd/m² calibrated, 1450 cd/m² Max.
Contrast Ratio: 900 : 1 (typical)	900 : 1 (typical)
DOT Clock: 162 MHz	188 MHz
Input Signals: Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital)	Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital)
Input Terminals: DVI-D, D-sub	DVI-D, D-sub
USB (option) / Standard	No
Active Display Size (H x V): Landscape: 433mmX325mm; Portrait: 325X433mm	Landscape: 433mmX325mm; Portrait: 325X433mm
Viewable Image Size: 540 mm (diagonal)	540 mm (diagonal)
Luminance Calibration: Software	Software
Default Gamma: 1.8,2.0,2.2 DICOM part 14 + off, user	1.8,2.0,2.2 DICOM part 14 user
Power: AC100-240V, 50/60Hz	AC100-240V, 50-60Hz
Power Consumption: 98W (Max)	100W (Max)
Power Save Mode: <2W	<2W
Dimensions (W x H x D):
W: Landscape: 467.8mm; Portrait:361.6 mm	Landscape: 467.8mm; Portrait:361.6 mm
H: Landscape: 434.3-584.3mm; Portrait: 487.4-637.4mm	Landscape:377.6-527.6mm; Portrait:483.4-580.7mm
D: 306 mm	227.6 mm
NET Weight: 10.7 kg	10.7 kg
Intended of use: Displaying and viewing of digital images for diagnosis by trained physicians; not for life-support, not for digital mammography, designed for interconnection with IEC60601-1-1 certified equipment	Displaying and viewing of digital images for diagnosis by trained physicians; not for life-support, not for digital mammography, designed for interconnection with IEC60601-1-1 certified equipment
Certifications & Standards: CE ITE/Medical Device Directive, UL/cUL (UL60601-1, CSA C22.2 No.601-1), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM	CE ITE/Medical Device Directive, UL/cUL (ANSI/AAMI ES 60601-1:2005), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM

Study Details:

Sample size used for the test set and the data provenance:
- The document does not specify a sample size for image data or specific cases used in performance testing.
- The testing performed was on the device itself as product, not on a dataset of patient images.
- Data Provenance: Not applicable in the context of image data. The device itself is manufactured by NEC Display Solutions Ltd. in Japan.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study focuses on technical performance of the monitor, not diagnostic accuracy based on expert interpretation of images displayed on it. The "trained physicians" are mentioned in the intended use, but not as part of the performance testing methodology.
Adjudication method for the test set:
- This information is not provided and is not directly relevant for the type of device (display monitor). The performance testing described refers to meeting technical criteria from AAPM Task Group 18, which would typically involve objective measurements rather than expert adjudication of clinical findings.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a display monitor, not an AI diagnostic algorithm.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not an algorithm. The performance testing was for the monitor itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on the specifications outlined in the AAPM Task Group 18 report ("Assessment of Display Performance for Medical Imaging Systems"). These are objective, measurable technical specifications (e.g., brightness, contrast, resolution, gray scale accuracy) rather than clinical diagnostic ground truth. The study states "The results showed that all the testing items met the criteria."
The sample size for the training set:
- Not applicable. This is a hardware device (monitor), not an AI algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable. This is a hardware device (monitor).

Summary

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OCT

510(K) Summary of Safety and Effectiveness

As required by 807.92

DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

Mr. Saohiko Shimazu Manager NEC Display Solutions Ltd. 4-28, Mita 1-chome, Minato-ku, Tokyo, Japan Ph: +81-465-85-2384 Fax: +81-465-85-2393

2. COMPANY REISTRATION NUMBER 3003623028

3. DATE SUMMARY PREPARED

21 June 2012

4. DEVICE NAME

Trade Name:	MD211G3 21.3" Diagnostic Imaging LCD monitor
Model Name:	MD211G3
Common Name:	Monochrome LCD Monitor, Monochrome Diagnostic Display, etc.
Classification Name:	System, Image Processing, Radiological (CLASS II CFR 892.2050)

4, PREDICATE DEVICE

L218TL 3MP Monochrome LCD Monitor by NEC Display Solutions Ltd. (K090215)

5. DEVICE DESCRIPTION

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6. DEVICE OF INTENDED USE

The MD211G3 gray scale display is intended to be use for displaying and viewing of digital images for diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers.

MD211G3 cannot be used for a life-support system.

This device must not be used in digital mammography.

This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.

7. SE Comparison Table:

Items	L218TL	MD211G3
510(k) Number	K090215
Panel Size and Type	21.3" TFT Monochrome LCD Monitor	21.3" TFT Monochrome LCD Monitor
Pixel Pitch	0.212 mm x 0.212mm	0.212 mm x 0.212mm
Display Monochromes	10-bit (1024 grey tones) with 3061 total colors	10-bit (1024 grey tones) with 3061 total colors
Viewing Angles (°)	H:176, V:176	H:176, V:176
Scanning Frequency (H, V)	31.5-95.4kHz, 30-85 Hz	31.5-95.4kHz, 30-85 Hz
Native Resolutions	2048X1536	2048X1536
Brightness	400 cd/m² calibrated,1450 cd/m² Max.	400 cd/m² calibrated,1450 cd/m² Max.
Contrast Ratio	900 : 1 (typical)	900 : 1 (typical)
DOT Clock	162 MHz	188 MHz
Input Signals	Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital)	Three connectors: one D-sub analog VGA; and two DVI-D (VGA analog or digital)
Input Terminals	DVI-D, D-sub	DVI-D, D-sub

	USB (option) / Standard	No	No
	Active Display Size (H x V)	Landscape: 433mmX325mmPortrait: 325X433mm	433 mm x 325 mm
	Viewable Image Size	540 mm (diagonal)	540 mm (diagonal)
	Luminance Calibration	Software	Software
	Default Gamma	1.8,2.0,2.2 DICOM part 14 + off, user	1.8,2.0,2.2 DICOM part 14 user
	Power	AC100-240V, 50/60Hz	AC100-240V, 50-60Hz
	Power Consumption	98W (Max)	100W (Max)
	Power Save Mode	<2W	<2W
	Dimensions(W x H x D)	W:Landscape: 467.8mmPortrait:361.6 mm	W:Landscape: 467.8mmPortrait:361.6 mm
		H:Landscape: 434.3-584.3mmPortrait: 487.4-637.4mm	H:Landscape:377.6-527.6mmPortrait:483.4-580.7mm
		D: 306 mm	D: 227.6 mm
		NET Weight	10.7 kg
			10.7 kg
	Intended of use	Displaying and viewing of digitalimages for diagnosis by trainedphysiciansThis device can not use for a lifesupport system.This device must not be use indigital mammography.This device is designed forexclusive interconnection withIEC60601-1-1certified equipment	Displaying and viewing ofdigital images for diagnosis bytrained physiciansThis device can not use for a lifesupport system.This device must not be use indigital mammography.This device is designed forexclusive interconnection withIEC60601-1-1certifiedequipment
	Certifications &Standards	CE ITE/Medical Device Directive,UL/cUL (UL60601-1, CSA C22.2No.601-1), FCC Class B,EN60601-1-2, DIN V 6868-57,DICOM	CE ITE/Medical DeviceDirective, UL/cUL(ANSI/AAMI ES60601-1:2005), FCC Class B,EN60601-1-2, DIN V 6868-57,DICOM

Comparison tables between MD211G3 & L218TL

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PERFORMANCE TESTING 8.

Test items according to "Assessment of Display Performance for Medical Imaging Systems" published by American Association of Physicists in Medicine (AAPM) Task Group 18 were performed to device MD211G3. The complete system configuration as well as the device verification and validation have also been assessed in-house. The results showed that all the testing items met the criteria. The predicate device - L218TL also has the above mentioned tests performed and has the same results and this demonstrates that MD211G3 and L218TL are equivalent in terms of performance.

9. CONCLUSION

These two devices have the same target population of trained practitioner in hospital; it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (AAMI/ES 60601-1) human factors and DICOM conformance. It use similar material, and have same compatibility with environment and other device. Comparison table of the principal characteristics of two devices is shown in the Section 3, table 3.3. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to L218TL by NEC Display Solutions Ltd. (K090215)

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure, with three flowing lines representing the head, body, and legs. The graphic is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

OCT

NEC Display Solutions Ltd. % Mr. Ned Devine Senior Staff Engineer/FDA Office Coordinator Underwriters Laboratories, Inc. 333 Pfingsten Road NORTHBROOK IL 60062

Re: K122843

Trade/Device Name: Medical Display, MD211G3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 11, 2012 Received: September 17, 2012

Dear Mr. Devine:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

5
2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Michael D. O'Hara firm

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Medical Display, MD211G3

Indications For Use: The MD211G3 gray scale display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display controllers.

MD211G3 cannot be used for a life-support system.

This device must not be used in digital mammography.

This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.

V Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K122843

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).