Medical Display, L218TL is a 21.3" Monochrome 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

The provided text is a 510(k) summary for a medical display monitor (NEC MD213 MG / L218TL). This type of document focuses on establishing substantial equivalence to a predicate device, primarily through comparing technical specifications and safety standards, rather than detailing a rigorous clinical study of acceptance criteria and device performance in the way an AI algorithm or diagnostic tool would.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies) are not applicable to this submission, as it relates to a hardware display device and not a diagnostic software or AI.

However, I can extract the relevant information from the document as best as possible within the context of a hardware device submission.

Acceptance Criteria and Study for NEC MD213 MG (L218TL) Medical Display

As this submission is for a medical display monitor, the "acceptance criteria" and "device performance" primarily revolve around technical specifications and regulatory compliance demonstrating substantial equivalence to a predicate device. A clinical study with specific diagnostic performance metrics (e.g., sensitivity, specificity for disease detection) and reader performance improvement is not typically performed for a display monitor.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Feature	Acceptance Standard (Implied by Predicate Equivalence)	Reported Device Performance (NEC MD213 MG / L218TL)
Intended Use	Displaying and viewing digital image diagnosis by trained physicians.	Same intended use as predicate.
Target Population	Trained practitioners in hospital environments.	Same target population as predicate.
Design	Equivalent to predicate device.	Same design as predicate.
Performance	Equivalent to predicate device.	Same performance as predicate.
Radiation Safety (EN60601-1-2)	Compliant with EN60601-1-2.	Same as predicate.
Mechanical Safety	Compliant with relevant safety standards.	Same as predicate.
Electrical Safety (UL60601-1)	Compliant with UL60601-1.	Same as predicate.
Human Factors	Equivalent to predicate device.	Same as predicate.
Materials	Similar to predicate device.	Similar to predicate.
Compatibility with Environment/Other Devices	Similar to predicate device.	Similar to predicate.
Screen Size	21.3 inches (based on predicate).	21.3 inches.
Resolution	3 Mega Pixel (e.g., 2048x1536).	3 Mega Pixel (2048x1536).
Adjustable Gamma Gray Scale	Included for precise diagnosis.	Included for precise diagnosis.
Use Cases	CT, MRI, HIS, PACS.	CT, MRI, HIS, PACS.
Approved Display Cards	Use with NEC approved display cards.	Required for specified display performance.
Life-Support System Use	Not for life-support systems.	Cannot be used for life-support systems.
Digital Mammography Use	Not for digital mammography.	Must not be used in digital mammography.
Interconnection	Designed for interconnection with IEC60601-1 certified equipment.	Designed for exclusive interconnection with IEC60601-1 certified equipment.

Study Details:

The "study" in this context is a substantial equivalence comparison to a legally marketed predicate device, MDM2130-3NC 21.3" 3MP Monochrome LCD Monitor by CHILIN Technology Co., Ltd. (K063266). The entire submission argues that the NEC L218TL device is substantially equivalent to this predicate based on shared design, performance, safety standards, and intended use.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable (N/A). This is a hardware device submission. There is no "test set" of patient data or images in the typical sense for evaluating diagnostic performance. The evaluation is based on the device's technical specifications and compliance with established safety and performance standards relevant to medical monitors.

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

Not Applicable (N/A). No "ground truth" was established from expert consensus on medical images for this hardware device.

4. Adjudication Method for the Test Set:

Not Applicable (N/A). No adjudication methods for diagnostic performance were employed.

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 (N/A). This is not an AI-assisted diagnostic device. It is a display monitor.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not Applicable (N/A). This is a display monitor, not an algorithm.

7. The Type of Ground Truth Used:

Not Applicable (N/A). For a medical display monitor, the "ground truth" is typically defined by adherence to objective performance standards (e.g., DICOM Part 14 Grayscale Standard Display Function compliance, luminance, contrast, resolution, uniformity) and safety standards (e.g., IEC 60601-1, EN 60601-1-2, UL 60601-1). The document states that the device meets these safety and performance requirements through comparison to the predicate device.

8. The Sample Size for the Training Set:

Not Applicable (N/A). There is no "training set" as this is a hardware device.

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

Not Applicable (N/A). There is no "training set" or corresponding ground truth for a hardware display device.

Summary

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KC90215
Page 1 of 2

510(K) Summary of Safety and Effectiveness

As required by 807.92

1. DEVICE ESTABLISHMENT AND CONTACT PERSON

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

APR 1 5 2009

2. COMPANY REISTRATION NUMBER 3003623028

3. DATE SUMMARY PREPARED

15 December 2008

4. DEVICE NAME

Trade Name:	MD213 MG 21.3" Diagnostic Imaging LCD monitor
Model Name:	L218TL
Common Name:	Monochrome LCD Monitor, Monochrome Diagnostic Display, etc.
Classification Name:	System, Image Processing, Radiological (CLASS II CFR 892.2050)

4. PREDICATE DEVICE

MDM2130-3NC 21.3" 3MP Monochrome LCD Monitor by CHILIN Technology Co., Ltd. (K063266).

DEVICE DESCRIPTION ર.

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KC90215
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DEVICE OF INTENDRD USE 6.

The L218TL monochrome display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards.

The L218TL cannot be used for a life-support system.

This device must not be used in digital mammography.

This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.

7. 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 (UL60601-1) and human factors. 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 MDM2130-3NC by Chi Lin Technology Co., Ltd. (K063266).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design that resembles an abstract human figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NEC Display Solutions, Ltd. c/o Mr. Morten Simon Christensen Asst. Manager, Program Reviewer UL Health Sciences Underwriters Laboratories, Inc. . 455 E. Trimble Road SAN JOSE CA 95131-1230

APR 1 5 2009

Re: K090215

Trade/Device Name: Medical Display, L218TL Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 26, 2009 Received: April 1, 2009

Dear Mr. Christensen:

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 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

K090215

Device Name: Medical Display, L218TL

Indications For USe: The L218TL Monochrome display is intended to be used for displaying and viewing of digital image diagnosis by trained physicians.

To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.

The L218TL cannot be used for a life-support system.

This device must not be used in digital mammography.

This unit is designed for exclusive interconnection with IEC60601-1 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 Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
98

510(k) Number

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).