Medical Display, MD210C3 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

I am sorry, but the provided text does not contain the detailed information needed to answer your request about acceptance criteria and a study proving device performance for a medical AI device.

The document is a 510(k) premarket notification for a diagnostic imaging LCD monitor (MD210C3), not an AI or algorithm-based device. Therefore, it discusses display specifications and comparisons to a predicate display, not AI performance metrics.

Specifically, the document does not contain any of the following information:

Acceptance criteria for an AI algorithm expressed in terms of metrics like sensitivity, specificity, or AUC.
Reported device performance (e.g., accuracy, recall) of an AI algorithm.
Sample sizes for test sets used for AI model evaluation.
Data provenance (country of origin, retrospective/prospective) for AI data.
Number of experts or their qualifications for establishing ground truth for AI.
Adjudication methods for an AI test set.
Multi-reader multi-case (MRMC) comparative effectiveness study information for AI.
Standalone performance data for an AI algorithm.
Type of ground truth used for AI (pathology, outcomes data).
Sample size for training set of an AI model.
How ground truth for the training set of an AI model was established.

The document primarily focuses on verifying that the new display (MD210C3) is substantially equivalent to a previously cleared predicate display (MD211C3) by comparing their physical and performance specifications as a display device. It mentions "Display Testing" with items like "Luminance Response" and "Display Resolution," and states "Test results showed minor differences between MD210C3 and MD211C3, however these differences are minor and were within the acceptable range of DICOM part 14." This refers to performance characteristics of a monitor, not an AI algorithm.

Summary

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December 10, 2014

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

NEC Display Solutions, Ltd. % Mr. Tony Hsu Project Engineer Prodigy Technology Consultant Co., Ltd. 1F, No. 181, Sec.2, Wunhua 1st Road Linkuo, New Taipei City, 24447 TAIWAN

Re: K142951

Trade/Device Name: MD210C3 21.3" Diagnostic Imaging LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: October 9, 2014 Received: October 16, 2014

Dear Mr. Hsu:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 yours.

Robert A Ochs

for

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) K142951

Device Name Medical Display, MD210C3

Indications for Use (Describe)
--------------------------------	--

The MD210C3 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.

MD210C3 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) Summary of Safety and Effectiveness

As required by 807.92

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.

19 September 2014

4. DEVICE NAME

Trade Name:	MD210C3 21.3" Diagnostic Imaging LCD monitor
Model Name:	MD210C3
Common Name:	Color LCD Monitor, Color Diagnostic Display, etc.
Classification Name:	System, Image Processing, Radiological (CLASS II CFR 892.2050)
Product Code:	PGY

PREDICATE DEVICE 4.

MD211C3 3MP Color LCD Monitor by NEC Display Solutions Ltd. (K130770)

ട. DEVICE DESCRIPTION

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DEVICE OF INTENDED USE 6.

The MD210C3 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.

MD210C3 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	MD211C3	MD210C3
510(k) Number	K130770
Panel Size and Type	21.3" TFT Color LCD Monitor	21.3" TFT Color LCD Monitor
Pixel Pitch	0.212 mm x 0.212mm	0.212 mm x 0.212mm
Display Color	1,073,741,824	1,073,741,824
Viewing Angles (°)	H:176, V:176	H:176, V:176
Scanning Frequency(H, V)	31.5-94.8, 126.3kHz , 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,800 cd/m² Max.	400 cd/m2 calibrated,800 cd/m² Max.
Contrast Ratio	1400 : 1 (typical)	1400 : 1 (typical)
DOT Clock	188 MHz	214.3 MHz
Input Signals	Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP	Two connectors: one DVI-D, one display port (Display port comply with standard V1.1a, applicable to HDCP
Input Terminals	DVI-D, Display port	DVI-D, Display port
USB (option) / Standard	No	No

Comparison tables between MD211C3 & MD210C3

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Active Display Size (H x	Landscape: 433mmX325mm	Landscape: 433mmX325mm
V)	Portrait: 325X433mm	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	1.8,2.0,2.2 DICOM part 14
Power	AC100-240V, 50/60Hz	AC100-240V, 50/60Hz
Input Rating	1.1-0.4A	1.1-0.44A
Power Save Mode	<2W	<2W

Dimensions	W:	W:
(W x H x D)	Landscape: 467.8mm	Landscape: 467.8mm
	Portrait:361.6 mm	Portrait:361.6 mm
	H:	H:
	Landscape:434.3.6-584.3mm	Landscape:434.3.6-584.3mm
	Portrait:487.4-637.4mm	Portrait:487.4-637.4mm
	D: 306 mm	D: 306 mm
NET Weight	11.8 kg	11.8 kg
Intended of use	Displaying and viewing of digital	Displaying and viewing of
	images for diagnosis by trained	digital images for diagnosis by
	physicians	trained physicians
	This device can not use for a life	This device can not use for a life
	support system.	support system.
	This device must not be use in	This device must not be use in
	digital mammography.	digital mammography.
	This device is designed for	This device is designed for
	exclusive interconnection with	exclusive interconnection with
	IEC60601-1-1certified equipment	IEC60601-1-1certified
		equipment
Certifications &	CE ITE/Medical Device Directive, CE ITE/Medical Device
Standards	UL/cUL (ANSI/AAMI ES	Directive, UL/cUL
	60601-1:2005), FCC Class B,	(ANSI/AAMI ES
	EN60601-1-2, DIN V 6868-57,	60601-1:2005), FCC Class B,
	DICOM	EN60601-1-2, DIN V 6868-57,
		DICOM

Modification	Testing
Change D/D board A to D/D board B	Low voltage reliability
Change input rating from 1.1- 0.4A to 1.1 - 0.44A	1) Power input test2) Humidity preconditioning treatment3) Temperature test4) Leakage current test

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Dot clock from 188 MHz to 214.3 MHz	--
-------------------------------------	----

Display Testing:

・ Display Reflection
・ Luminance Response
・ Luminance Uniformity
・ Display Resolution
Display Noise
Veiling Glare
・ Display Chromaticity
Miscellaneous Tests

Summary: Test results showed minor differences between MD210C3 and MD211C3, however these differences are minor and were within the acceptable range of DICOM part 14.

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CONCLUSION

1. MD210C3 is identical to MD211C3 except for different D/D board of LED backlight, change current rating from 1.1-0.4A to 1.1 - 0.44A, dot clock has also improved from 188 MHZ to 214.3 MHZ.
1. 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. The SE Comparison Table compares the principal characteristics of two devices. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to MD211C3 by NEC Display Solutions Ltd. (K130770)

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).