MD301C4 is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. Caution: MD301C4 cannot be used for a life-support system. This unit is designed as component of a final system which is compliance to IEC60601-1-1 requirements. MD301C4 must not be used in digital mammography.

Device Description

Medical Display, MD301C4 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. MD301C4 conforms with DICOM.

AI/ML Overview

The provided text is a 510(k) summary for a medical display (MD301C4). It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI algorithm.

This document describes a medical display device and demonstrates its substantial equivalence to a predicate display device. It focuses on physical and technical specifications of the monitor itself, rather than the performance of an AI algorithm or software. Therefore, most of the requested information cannot be extracted from the provided text.

Here is an explanation of why the requested information is not available:

This is a 510(k) for a display monitor, not an AI diagnostic device. The device (MD301C4) is a "Color LCD Monitor, Color Diagnostic Display," intended for "displaying and viewing of digital images for diagnosis." It does not contain or utilize an AI algorithm for diagnostic purposes.
The "study" mentioned is a comparison of the new monitor to a predicate monitor to establish substantial equivalence. It's not a clinical performance study involving AI and human readers. The conclusion states: "Device with trade name MD301C4 (model name is L309TY) and predicate device with trade name MD304MC (model name is L307TD) have the same target population... it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1) and human factors." This is the "study" proving it meets acceptance criteria, which is essentially demonstrating equivalence to an already approved device.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be inferred or stated as "not applicable" based on the document:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) is "substantial equivalence" to the predicate device (MD304MC, K083916) in terms of design, performance (implied regulatory compliance like DICOM conformance), safety (radiation, mechanical, electrical), human factors, and intended use. Specific quantitative performance metrics for diagnostic accuracy of an AI are not applicable.
- Reported Device Performance: The document states the device "conforms with DICOM" and has "4 mega pixel (2560*1600) resolution with adjustable gamma gray scale." The "performance" in the context of this device refers to its display capabilities and regulatory compliance, not diagnostic accuracy.
Sample size used for the test set and the data provenance: Not applicable. There is no diagnostic AI test set. This is a display device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no AI test set requiring expert ground truth.
Adjudication method for the test set: Not applicable.
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 study was not done for AI performance. The equivalence study compares properties of the display monitors themselves.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. This is not an AI algorithm.
How the ground truth for the training set was established: Not applicable. This is not an AI algorithm.

Summary

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K111237

JUN 1 5 2018

510(K) Summary of Safety and Effectiveness

As required by 807.92

DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

Mr. Shuichi Kino Manager NEC Display Solutions Ltd. 4-13-23 Shibaura, Minato-ku, Tokyo, 108-0023 Japan Ph: +81-465-85-2376 Fax: +81-465-85-2378

2. COMPANY REISTRATION NUMBER

3003623028

..............................................................................................................................................................................

3. DATE SUMMARY PREPARED

09 February 2011

4. DEVICE NAME

Trade Name:	MD301C4 29.8" Diagnostic Imaging LCD monitor
Model Name:	L309TY
Common Name:	Color LCD Monitor, Color Diagnostic Display, etc.
Classification Name:	System, Image Processing, Radiological (CLASS II CFR 892.2050)

4. PREDICATE DEVICE

MD304MC 29.8" 4MP Color LCD Monitor by NEC Display Solutions Ltd. (K083916). Trade Name: MD304MC 29.8" Diagnostic Imaging LCD monitor L307TD Model Name:

DEVICE DESCRIPTION క.

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INDICATION OF USE 6.

MD301C4 is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.

Caution: MD301C4 cannot be used for a life-support system.

This unit is designed as component of a final system which is compliance to IEC60601-1-1 requirements.

MD301C4 must not be used in digital mammography.

7. CONCLUSION

Device with trade name MD301C4 (model name is L309TY) and predicate device with trade name MD304MC (model name is L307TD) 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 (UL60601-1) and human factors. It uses similar material, and has same compatibility with environment and other devices. The differences between the two devices are display colors (MD304MC can display more colors), input signals, input terminals, and USB input, power consumes in power save mode (MD301C4 consumes less power in power save mode), power consumption (MD301C4 consumes more power), however these do not effect the safety and effectiveness of the MD301C4 to be substantially equivalent to the predicate device. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to MD304MC by NEC Display Solutions Ltd. (K083916).

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

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

NEC Display Solutions Ltd. % Mr. Marc Mouser Engineering Leader/ FDA Office Coordinator Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

JUN 1 5 2011

Re: K111237

Trade/Device Name: Medical Display, MD301C4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 25, 2011 Received: June 3, 2011

Dear Mr. Mouser:

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 of

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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.

Mary Patel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

5:10(k) Number (if known):

Device Name: Medical Display, MD301C4

Indications For Use: MD301C4 is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.

Caution: MD301C4 cannot be used for a life-support system. This unit is designed as component of a final system which is compliance to IEC60601-1-1 requirements. MD301C4 must not be used in digital mammography.

Prescription Use Over-The-Counter Use X (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

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

Mary S. Postel

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K///237

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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).