Medical Display, MD211C2 is a 21.3" Color LCD monitor that displays image for medical use. It provides 1.9 mega pixel (1600*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

AI/ML Overview

This document describes a medical device called the MD211C2, a 21.3" Color LCD monitor intended for displaying and viewing digital images for diagnosis by trained physicians. The submission (K130772) from NEC Display Solutions Ltd. seeks to establish substantial equivalence to a predicate device, the L217TG. The study provided focuses on demonstrating equivalence through a comparison of technical specifications, rather than a clinical performance study with acceptance criteria in the typical sense for an AI/CADe device.

Here's an analysis based on the provided text, outlining what's available and what's not given the nature of the device (a display monitor):

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present specific acceptance criteria in the form of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it's a display monitor, not a diagnostic algorithm. Instead, it relies on demonstrating that the new device's technical specifications are comparable to or improved over a legally marketed predicate device. The "acceptance criteria" can be inferred as matching or exceeding the performance characteristics of the predicate device (L217TG).

Feature / Criterion (Implied Acceptance)	Predicate Device (L217TG) Performance	Subject Device (MD211C2) Performance
Panel Size and Type	21.3" TFT Color LCD Monitor	21.3" TFT Color LCD Monitor
Pixel Pitch	0.270 mm x 0.270 mm	0.270 mm x 0.270mm
Display Color	16,777,216	1,073,741,824 (Improved)
Viewing Angles (°)	H:176, V:176	H:176, V:176
Scanning Frequency (H, V)	31.5-91.1kHz , 50-85 Hz	31.5-74.5, 99.4kHz, 50-85 Hz (Slight difference, still within range)
Native Resolutions	1600X1200	1600X1200
Brightness (calibrated)	400 cd/m2	400 cd/m2
Brightness (Max)	850 cd/m2	900 cd/m2 (Improved)
Contrast Ratio	1050 : 1 (typical)	1400 : 1 (typical) (Improved)
DOT Clock	162 MHz	165 MHz (Slight difference, still comparable)
Input Signals	Three connectors: one D-sub analog VGA; and two DVI-I (VGA analog or digital)	Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP) (Different but equivalent modern interfaces)
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 (Slight difference: "off, user" removed, but core DICOM support remains)
Intended Use	Displaying and viewing of digital images for diagnosis by trained physicians. Not for life support/digital mammography. Interconnect with IEC60601-1-1 certified equipment.	Displaying and viewing of digital images for diagnosis by trained physicians. Not for life support/digital mammography. Interconnect with IEC60601-1-1 certified equipment. (Identical)
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 (Updated UL/cUL standard, otherwise comparable)

The study essentially is the comparison table provided, demonstrating that the MD211C2 is technically equivalent or superior to the L217TG across critical display specifications and meets relevant safety and performance standards.

2. Sample size used for the test set and the data provenance:

Sample Size: Not applicable. This is not a study assessing diagnostic performance on a dataset of patient images. It's a technical comparison of a hardware device.
Data Provenance: Not applicable. The "data" here refers to the specifications and performance measurements of the display monitors themselves, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth, in the context of diagnostic interpretation, is not relevant for evaluating a display monitor's technical specifications.

4. Adjudication method for the test set:

Not applicable. There is no diagnostic test set 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:

No, a MRMC study was not done. This device is a display monitor, not an AI or CADe system. There is no AI component involved, so no improvement statistics for human readers are relevant.

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

No, a standalone algorithm performance study was not done. This is a display monitor, not an algorithm.

7. The type of ground truth used:

Not applicable. Ground truth for diagnostic interpretations is not relevant. The "ground truth" for this device's performance relies on engineering specifications, measurements, and adherence to established standards (e.g., DICOM, IEC).

8. The sample size for the training set:

Not applicable. This device does not involve machine learning algorithms requiring a training set.

9. How the ground truth for the training set was established:

Not applicable. As there is no training set, there is no ground truth for it to be established.

Summary of the Study:

The study presented is a technical comparison between the proposed device (MD211C2) and a legally marketed predicate device (L217TG). It primarily relies on a comparative table of specifications and certifications to demonstrate substantial equivalence. The conclusion drawn is that both devices share the same intended use, design, performance, and safety characteristics (radiation, mechanical, electrical, human factors, DICOM conformance), and utilize similar materials and environmental compatibility. This comparison allows the manufacturer to assert that the MD211C2 is substantially equivalent to the predicate device, enabling its market clearance under 510(k).

Summary

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K130772
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510(K) Summary of Safety and Effectiveness

As required by 807.92

APR 1 8 2013

DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

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

DATE SUMMARY PREPARED 3.

12 October 2012

4, DEVICE NAME

Trade Name:	MD211C2 21.3" Diagnostic Imaging LCD monitor
Model Name:	MD211C2
Common Name:	Color LCD Monitor, Color Diagnostic Display, etc.
Classification Name:	System, Image Processing, Radiological (CLASS II CF 892.2050)

4. PREDICATE DEVICE

L217TG TFT Color LCD Monitor by NEC Display Solutions Ltd. (K083907)

DEVICE DESCRIPTION 5.

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DEVICE OF INTENDED USE 6.

The MD211C2 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.

MD211C2 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	L217TG	MD211C2
510(k) Number	K083907
Panel Size and Type	21.3" TFT Color LCD Monitor	21.3" TFT Color LCD Monitor
Pixel Pitch	0.270 mm x 0.270 mm	0.270 mm x 0.270mm
Display Color	16.777,216	1,073,741,824
Viewing Angles (°)	H:176, V:176	H:176, V:176
Scanning Frequency(H, V)	31.5-91.1kHz , 50-85 Hz	31.5-74.5, 99.4kHz, 50-85 Hz
Native Resolutions	1600X1200	1600X1200
Brightness	400 cd/m2 calibrated,850 cd/m2 Max.	400 cd/m2 calibrated,900 cd/m2 Max.
Contrast Ratio	1050 : 1 (typical)	1400 : 1 (typical)
DOT Clock	162 MHz	165 MHz
Input Signals	Three connectors: one D-subanalog VGA; and two DVI-I(VGA analog or digital)	Two connectors: one DVI-D,one display port (Display portcomply with standard V1.1a,applicable to HDCP
Input Terminals	DVI-D, D-sub	DVI-D, Display port
USB (option) / Standard	No	No
Active Display Size (H x V)	Landscape: 432mmX324mmPortrait: 324X432mm	Landscape: 432mmX324mmPortrait: 324X432mm
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	100W (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:377.6-527.6mmPortrait:483.4-580.7mmD: 227.6 mm
NET Weight	10.7 kg	11.8 kg
Intended of use	Displaying and viewing of digital images for diagnosis by trained physiciansThis device can not use for a life support system.This device must not be use in digital mammography.This device is designed for exclusive interconnection with IEC60601-1-1certified equipment	Displaying and viewing of digital images for diagnosis by trained physiciansThis device can not use for a life support system.This device must not be use in digital mammography.This device is designed for exclusive interconnection with IEC60601-1-1certified 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

Comparison tables between MD211C2 & L217TG

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K130772
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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 L217TG by NEC Display Solutions Ltd. (K083907)

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

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. 12 Laboratory Drive RESEARCH TRIANGLE PARK NC 27709

Re: K130772

Trade/Device Name: MD211C2 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/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/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Jamingh. Messa

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): K130772

Device Name: Medical Display, MD211C2

Indications for Use:

The MD211C2 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.

MD211C2 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)

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

K130772 510(k)

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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).