Medical Display, MD302C4 is a 29.8" Color LCD monitor that displays image for medical use. It provides 4 mega pixel (2560*1600) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.

AI/ML Overview

This document describes a 510(k) premarket notification for a diagnostic imaging LCD monitor (MD302C4). The submission aims to demonstrate substantial equivalence to a predicate device (MD242C2) rather than proving the device meets specific acceptance criteria through a clinical study. As such, most of the requested information (sample size, data provenance, expert qualification, adjudication method, MRMC study, standalone performance, training set details) is not applicable to this type of submission.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in the typical sense of a clinical study with performance metrics. Instead, it compares the technical specifications and intended use of the new device (MD302C4) to a predicate device (MD242C2) to establish substantial equivalence. The "acceptance criteria" here are implicitly that the new device's performance characteristics are comparable or superior to the predicate device, or fall within acceptable ranges for diagnostic display devices.

Items	Predicate Device (MD242C2)	Reported Device Performance (MD302C4)
Panel Size and Type	24.1" TFT Color LCD Monitor	29.8" TFT Color LCD Monitor
Pixel Pitch	0.270 mm x 0.270mm	0.251mm x 0.251mm
Display Color	1,073,741,824	16,777,216
Viewing Angles (°)	H:178, V:178	H:178, V:178
Scanning Frequency(H, V)	31.5-93.8, 118.4kHz, 50-85 Hz	31.5-98.7 kHz, 50-85 Hz
Native Resolutions	1920X1200	2560X1600
Brightness	180 cd/m² calibrated,350 cd/m² Max.	180 cd/m² calibrated,340 cd/m² Max.
Contrast Ratio	1000 : 1 (typical)	1000 : 1 (typical)
DOT Clock	202.5 MHz (Max) (Analog)162 MHz (Max) (Digital)	269 MHz (Max)
Input Signals	Three connectors: one DVI port,one Display port, one HDMI port.	Three connectors: one DVI port,one Display port, one HDMIport.
Input Terminals	DVI-D, Display port, HDMI port	DVI-D, Display port, HDMI port
USB (option) / Standard	No	No
Active Display Size (H x V)	Landscape: 518.4mmX324mmPortrait: 324X518.4mm	Landscape: 641mmX401mmPortrait: 401X641mm
Viewable Image Size	540 mm (diagonal)	756 mm
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
Power Consumption	38.4W (Max)	87W (Max)
Power Save Mode	<2W	<2W
Dimensions (W x H x D)	W:Landscape: 556.8mmPortrait: 362.4 mmH:Landscape: 378 - 528mmPortrait: 572.4-625.2mmD: 227.6 mm	W:Landscape: 688mmPortrait: 446.8 mmH:Landscape: 466.4 - 616.4mmPortrait: 707.1-737.0mmD: 301.6 mm
NET Weight	10.2 kg	17 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 IEC60601-1-1 certified 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 IEC60601-1-1 certified equipment
Certifications & Standards	CE ITE/Medical Device Directive, UL/cUL (ANSI/AAMI ES 60601-1:2005), 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

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

Not applicable. This is a 510(k) submission for a display monitor, not an AI/algorithm-based diagnostic device requiring a test set of medical data (images, patient records, etc.). The "test" in this context refers to engineering and performance verification of the display hardware against technical specifications and safety standards.

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

Not applicable. Ground truth typically refers to clinical diagnoses or pathology results for AI/algorithm validation. For a display monitor, "ground truth" would be the expected performance based on engineering specifications and calibration.

4. Adjudication method for the test set

Not applicable.

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 device is a display monitor, not an AI-assisted diagnostic tool.

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

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

7. The type of ground truth used

Not applicable in the clinical sense. The "ground truth" for evaluating this device would be its adherence to established technical specifications, industry standards (like DICOM Part 14), and safety regulations, verified through engineering tests and calibrations.

8. The sample size for the training set

Not applicable. This is a hardware device (display monitor), not a machine learning algorithm that requires a training set.

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

Not applicable.

Summary

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KB33708
Page 1 of 4

510(K) Summary of Safety and Effectiveness

As required by 807.92

FEB 1 4 2014

DEVICE ESTABLISHMENT AND CONTACT PERSON l.

Mr. Naohiko Shimazu Senior Manager NEC Display Solutions Ltd. 686-1 NISHIOI, OI-MACHI, ASHIGARAKAMI-GUN, KANAGAWA, 258-8533, Japan Ph: +81-465-85-2384 Fax: +81-465-85-2393

2. COMPANY REISTRATION NUMBER

3003623028

3. DATE SUMMARY PREPARED

09 October 2013

4, DEVICE NAME

Trade Name:	MD302C4 29.8" Diagnostic Imaging LCD monitor
Model Name:	MD302C4
Common Name:	Color LCD Monitor, Color Diagnostic Display, etc.
Classification Name:	System, Image Processing, Radiological (CLASS II CFR892.2050)

PREDICATE DEVICE 4.

MD242C2 Color LCD Monitor by NEC Display Solutions Ltd. (K 132587)

DEVICE DESCRIPTION 5.

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6. DEVICE OF INTENDED USE

The MD302C4 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.

MD302C4 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	MD242C2	MD302C4
510(k) Number
Panel Size and Type	24.1" TFT Color LCD Monitor	29.8" TFT Color LCD Monitor
Pixel Pitch	0.270 mm x 0.270mm	0.251mm x 0.251mm
Display Color	1,073,741,824	16,777,216
Viewing Angles (°)	H:178, V:178	H:178, V:178
Scanning Frequency(H, V)	31.5-93.8, 118.4kHz, 50-85 Hz	31.5-98.7 kHz, 50-85 Hz
Native Resolutions	1920X1200	2560X1600
Brightness	180 cd/m² calibrated,350 cd/m² Max.	180 cd/m² calibrated,340 cd/m² Max.
Contrast Ratio	1000 : 1 (typical)	1000 : 1 (typical)
DOT Clock	202.5 MHz (Max) (Analog)162 MHz (Max) (Digital)	269 MHz (Max)
Input Signals	Three connectors: one DVI port,one Display port, one HDMI port.	Three connectors: one DVI port,one Display port, one HDMIport.
Input Terminals	DVI-D, Display port, HDMI port	DVI-D, Display port, HDMI port
USB (option) / Standard	No	No
Active Display Size (H x V)	Landscape: 518.4mmX324mmPortrait: 324X518.4mm	Landscape: 641mmX401mmPortrait: 401X641mm
Viewable Image Size	540 mm (diagonal)	756 mm
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
Power Consumption	38.4W (Max)	87W (Max)
Power Save Mode	<2W	<2W
Dimensions (W x H x D)	W:Landscape: 556.8mmPortrait: 362.4 mmH:Landscape: 378 - 528mmPortrait: 572.4-625.2mmD: 227.6 mm	W:Landscape: 688mmPortrait: 446.8 mmH:Landscape: 466.4 - 616.4mmPortrait: 707.1-737.0mmD: 301.6 mm
NET Weight	10.2 kg	17 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 IEC60601-1-1 certified 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 IEC60601-1-1 certified equipment
Certifications & Standards	CE ITE/Medical Device Directive, UL/cUL (ANSI/AAMI ES 60601-1:2005), 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 MD302C4 & MD242C2

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K133708
Page 4 of 4

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 MD242C2 by NEC Display Solutions Ltd. (K132587)

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Public Health Service

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

February 14, 2014

NEC Display Solutions, Ltd. % Mr. Tony Hsu Safety Engineer Prodigy Technology Consultant Co., Ltd. 1F, No. 181, Sec. 2 Wunhua 1st Road. Linkou Township NEW TAIPEI CITY 24457 TAIWAN

Re: K133708

Trade/Device Name: MD302C4 29.8" Diagnostic Imaging LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 23, 2013 Received: December 23, 2013

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, listing 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2-Mr. Hsu

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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133708

Device Name MD302C4

Indications for Use (Describe)

The MD302C4 color display is intended to be used for displaying 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.

MD302C4 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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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).