The MD211C3 color 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 in conjunction with NEC approved display controllers. MD211C3 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.

Device Description

Medical Display, MD211C3 is a 21.3" Color 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 provided text regarding the acceptance criteria and study for the MD211C3 display, structured as requested.

Important Note: The provided document is a 510(k) summary for a medical display monitor. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a full efficacy study of a new medical algorithm or diagnostic tool. Therefore, many of the requested categories related to algorithm performance, ground truth, and human reader studies are not applicable or will have "N/A" (Not Applicable) as the MD211C3 is a display device, not an AI-powered diagnostic tool.

Acceptance Criteria and Study for MD211C3 Diagnostic Imaging LCD Monitor

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MD211C3 are primarily based on demonstrating substantial equivalence to its predicate device, the L218TL 3MP Monochrome LCD Monitor (K090215), as well as adherence to relevant medical and safety standards. The document outlines a comparison of technical specifications between the two devices.

Feature / Standard	Acceptance Criteria (Predicate: L218TL)	Reported Device Performance (MD211C3)
Panel Type	21.3" TFT Monochrome LCD Monitor	21.3" TFT Color LCD Monitor
Pixel Pitch	0.212 mm x 0.212mm	0.212 mm x 0.212mm
Native Resolution	2048x1536 (Landscape), 1536x2048 (Portrait)	2048x1536 (Landscape), 1536x2048 (Portrait)
Brightness	400 cd/m² calibrated, 1450 cd/m² Max.	400 cd/m² calibrated, 800 cd/m² Max.
Contrast Ratio	900 : 1 (typical)	1400 : 1 (typical)
Display Color Depth	10-bit (1024 grey tones) with 3061 total colors	1,073,741,824 colors
Intended 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. (Identical)
Certifications & Standards (Safety/EMC/DICOM)	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
Radiation Safety	Equivalent to Predicate	Same performance as predicate (EN60601-1-2)
Mechanical Safety	Equivalent to Predicate	Same performance as predicate
Electrical Safety	Equivalent to Predicate (AAMI/ES 60601-1)	Same performance as predicate (AAMI/ES 60601-1)
Human Factors	Equivalent to Predicate	Same performance as predicate
DICOM Conformance	Equivalent to Predicate	Same performance as predicate

2. Sample Size for Test Set and Data Provenance

This is an approval for a display monitor, not an AI algorithm or a diagnostic device that analyzes data. Therefore, the concept of a "test set" comprised of medical images or patient data, and its provenance, is not applicable. The testing would have involved engineering and performance verification tests of the monitor itself (e.g., luminance, chromaticity, resolution, stability, adherence to DICOM Part 14 grayscale standard display function, and safety standards like IEC 60601-1 and EN60601-1-2).

Sample Size for Test Set: N/A (Not applicable for a display monitor).
Data Provenance: N/A (No patient or image data set used in the sense of an algorithm study). Testing would typically occur in laboratory settings by engineers.

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

Number of Experts: N/A
Qualifications of Experts: N/A

As this is a display monitor, the "ground truth" relates to its physical performance characteristics (e.g., precise measurements of brightness, contrast, color accuracy, resolution, stability, and adherence to DICOM calibration) as measured by calibrated instruments and verified against engineering specifications and industry standards. This isn't a diagnostic ground truth established by medical experts.

4. Adjudication Method for the Test Set

Adjudication Method: N/A

There is no "adjudication" in the context of an algorithm's output for a display monitor. Performance is measured against objective technical standards.

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

Was an MRMC study done? No.
Effect size of human readers improving with AI vs without AI assistance: N/A.

This device is a display monitor, not an AI-enabled diagnostic tool; therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable.

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

Was a standalone study done? No.

This device is a display monitor. It does not contain an algorithm that performs diagnostic analysis in a "standalone" fashion. Its function is to display images accurately for human interpretation.

7. Type of Ground Truth Used

The "ground truth" for a medical display monitor is defined by:

Objective Technical Specifications: Measurements of luminance, chromaticity, resolution, uniformity, stability, and viewing angle characteristics.
Adherence to Industry Standards: Conformance to DICOM Part 14 Grayscale Standard Display Function (GSDF) for accurate grayscale reproduction.
Safety and EMC Standards: Compliance with standards like IEC 60601-1 (medical electrical equipment safety), EN60601-1-2 (electromagnetic compatibility), and DIN V 6868-57 (quality assurance for image display systems).

8. Sample Size for the Training Set

Sample Size for Training Set: N/A

As a display monitor, there is no "training set" in the context of machine learning. The device is manufactured and calibrated according to established engineering principles and production controls.

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

How Ground Truth for Training Set Was Established: N/A

Since there is no training set for a machine learning algorithm, this question is not applicable. The display's performance characteristics (its "ground truth") are established through design specifications, calibration procedures, and adherence to international standards for medical displays.

Summary

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K130770
page 1 of 4

510(K) Summary of Safety and Effectiveness

APR 1 8 2013

As required by 807.92

1. DEVICE ESTABLISHMENT AND CONTACT PERSON

Mr. Satoru Kotani 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

12 October 2012

4. DEVICE NAME

Trade Name:	MD211C3 21.3" Diagnostic Imaging LCD monitor
Model Name:	MD211C3
Common Name:	Color LCD Monitor, Color 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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K130770
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6. DEVICE OF INTENDED USE

The MD211C3 color 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 in conjunction with NEC approved display controllers.

MD211C3 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:

Comparison tables between MD211C3 & L218TL

Items	L218TL	MD211C3
510(k) Number	K090215
Panel Size and Type	21.3" TFT Monochrome LCDMonitor	21.3" TFT Color LCD Monitor
Pixel Pitch	0.212 mm x 0.212mm	0.212 mm x 0.212mm
Display Color	10-bit (1024 grey tones) with 3061total colors	1,073,741,824
Viewing Angles (")	H:176, V:176	H:176, V:176
Scanning Frequency(H, V)	31.5-95.4kHz , 30, 50-85 Hz	31.5-94.8, 126.3kHz , 30, 50-85 Hz
Native Resolutions	2048X1536 (Landscape)1536X2048 (Portrait)	2048X1536 (Landscape)1536X2048 (Portrait)
Brightness	400 cd/m² calibrated,1450 cd/m² Max.	400 cd/m² calibrated,800 cd/m² Max.
Contrast Ratio	900 : 1 (typical)	1400 : 1 (typical)
DOT Clock	162 MHz	188 MHz
Input Signals	Two connectors: one D-sub analogVGA; and one DVI-I (VGAanalog or digital)	Two connectors: one DVI-D,one display port (Display portcomply with standard VI.1a
		applicable to HDCP
Input Terminals	DVI-D, D-sub	DVI-D, Display port
USB (option) / Standard	No	No
Active Display Size (H xV)	Landscape: 433mmX325mmPortrait: 325X433mm	Landscape: 433mmX325mmPortrait: 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
Power	AC100-240V, 50/60Hz	AC100-240V, 50/60Hz
Power Consumption	98W (Max)	88W (Max)
Power Save Mode	<2W	<2W
Dimensions(W x H x D)	W:Landscape: 467.8mmPortrait:361.6 mmH:Landscape: 434.3-584.3mmPortrait: 487.4-637.4mmD: 306 mm	W:Landscape: 467.8mmPortrait:361.6 mmH:Landscape:434.3-584.3mmPortrait:487.4-637.4mmD: 306 mm
NET Weight	10.7 kg	11.8 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

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K130770
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Image /page/3/Picture/0 description: The image shows handwritten text on a white background. The text includes the identifier "K130770" and the phrase "page 4 of 4". The handwriting is cursive and appears to be done with a pen or marker.

8. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized symbol featuring three overlapping, curved lines that resemble a caduceus without the snake.

Public Health Service

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

April 18, 2013

NEC Display Solutions, Ltd. % Mr. Jeffrey D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. l 2 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709

Re: K130770

Trade/Device Name: MD211C3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 6, 2013 Received: April 3, 2013

Dear Mr. Rongero:

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); medical device reporting (reporting of medical

device-related adverse events) (21 CFR 803); 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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Page 2 - Mr. Rongero

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Jamingh. M. Mange

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

K130770 510(k) Number (if known):

Device Name: Medical Display, MD211C3

Indications for Use:

The MD211C3 color 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.

MD211C3 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.

Prescription Use · V (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 Diagnostics and Radiological Health (OIR)

Ramingh. Messo

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K130770 510(k)

Page 1 of

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).