Medical Display, L307TD 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

Here's an analysis of the provided text regarding the NEC L307TD Medical Display, focusing on acceptance criteria and study details.

Based solely on the provided document (K083916 510(k) Summary), the information requested about acceptance criteria and a detailed study proving performance is not explicitly contained.

This 510(k) summary is for a medical display monitor, not an AI algorithm or a diagnostic device that performs interpretations. Therefore, the "acceptance criteria" discussed are largely related to electrical safety, mechanical safety, human factors, and display performance specifications (e.g., resolution, gamma grayscale adjustment) to ensure it's suitable for displaying medical images, rather than diagnostic accuracy metrics like sensitivity or specificity. The "study" proving performance is a substantial equivalence comparison to a predicate device, not a clinical trial involving human readers or a standalone algorithm.

Here's how to address your points based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of acceptance criteria with numerical performance data in the way one would expect for an AI diagnostic device. Instead, the basis for acceptance is a demonstration of equivalence to a legally marketed predicate device (MDC2130-2HC by CHILIN Technology Co., Ltd. - K063579) across various characteristics.

Acceptance Criteria (Implied from Equivalence Claim)	Reported Device Performance (Implied from Equivalence Claim)
Intended Use	Same target population (trained practitioners in hospital), same intended use (displaying digital image diagnosis).
Design	Shares the same design as the predicate.
Performance (General)	Same general performance as the predicate (e.g., sufficient for digital image diagnosis). Explicitly states 4 megapixel (2560x1600) resolution with adjustable gamma grayscale.
Radiation Safety	EN60601-1-2 compliant (same as predicate).
Mechanical Safety	Compliant (same as predicate).
Electrical Safety	UL60601-1 compliant (same as predicate).
Human Factors	Compliant (same as predicate).
Material	Uses similar material as the predicate.
Compatibility (Environment & Other Devices)	Same compatibility as the predicate.

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

Not Applicable / Not Provided: For a medical display monitor's 510(k) submission based on substantial equivalence, there isn't a "test set" of medical images or patient data in the context of diagnostic accuracy. The testing involves engineering and safety evaluations against standards and comparison to a predicate device's specifications. The document does not mention any medical image datasets being used for testing or evaluation of diagnostic performance.

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

Not Applicable / Not Provided: As there is no diagnostic "test set" of patient cases for interpretation, there are no experts establishing ground truth for such a set. The "ground truth" for a display monitor relates to engineering specifications and safety compliance.

4. Adjudication Method for the Test Set

Not Applicable / Not Provided: No diagnostic test set, therefore no adjudication method for ground truth.

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: This document is for a medical display monitor. MRMC studies are relevant for diagnostic algorithms or systems that assist human readers in making diagnoses. This device simply provides the visual interface.

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

No: This device is a display monitor, not an algorithm.

7. The type of Ground Truth Used

Engineering Specifications and Regulatory Standards: The "ground truth" in this context refers to established technical specifications (e.g., resolution, grayscale accuracy, contrast, brightness) and compliance with electrical, mechanical, and radiation safety standards (e.g., IEC60601-1, UL60601-1, EN60601-1-2).

8. The Sample Size for the Training Set

Not Applicable / Not Provided: As this is a display monitor, there is no "training set" in the context of machine learning or diagnostic algorithms.

9. How the Ground Truth for the Training Set was Established

Not Applicable / Not Provided: No training set exists for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria (as per K083916):

The "study" proving the device meets its "acceptance criteria" is a substantial equivalence demonstration to a legally marketed predicate device (MDC2130-2HC by CHILIN Technology Co., Ltd. - K063579).

The manufacturer (NEC Display Solutions Ltd.) states that the L307TD Medical Display is substantially equivalent to its predicate because:

They have the same intended use: displaying digital image diagnosis by trained physicians.
They share the same design, performance characteristics (e.g., 4 megapixel resolution, adjustable gamma), and are the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (UL60601-1), and human factors.
They use similar material.
They have the same compatibility with environment and other devices.
They serve the same target population of trained practitioners in a hospital setting.

This 510(k) summary (K083916) does not detail specific experiments, clinical trials, or performance metrics beyond the general statement of equivalence and the device's technical specifications relevant to its function as a display monitor. The FDA's 510(k) clearance process determined that the device is "substantially equivalent" to the predicate, meaning it is as safe and effective as the predicate device.

Summary

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K083916

JAN 14 2009

510(K) Summary of Safety and Effectiveness

As required by 807.92

DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

Mr. Osamu Lseki

General Manager

NEC Display Solutions Ltd.

4-13-23 Shibaura, Minato-ku, Tokyo, 108-0023 Japan

Ph: +81-465-85-2376

COMPANY REISTRATION NUMBER 2. 3003623028

DATE SUMMARY PREPARED 3.

01 October 2008

4. DEVICE NAME

Trade Name:

LCD3090WQXi or MD304MC 29.8" Diagnostic Imaging LCD monitor L307TD Model Number: Color LCD Monitor, Color Diagnostic Display, etc. Common Name: System, Image Processing, Radiological (CLASS II CFR Classification Name: 892.2050)

4. PREDICATE DEVICE

MDC2130-2HC 21.3" 2MP Color LCD Monitor by CHILIN Technology Co., Ltd. (K063579).

DEVICE DESCRIPTION 5.

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6. INTENDRD USE OF DEVICE

The L307TD color display is intended to be used for displaying 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 L307TD 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 MDC2130-2HC by Chi Lin Technology Co., Ltd. (K063579).

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three bars representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JAN 1 4 2009

Re: K083916

Trade/Device Name: Medical Display, L307TD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 12, 2008

Received: December 30, 2008

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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os 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 Part 801), please contact the 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, 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.suppot/index.html.

Sincerely yours,

Janine M. Morris

anine 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): K O83916

K083916

Device Name: Medical Display, L307TD

Indications For USe. The L307TD Color 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.

TheL307TD 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 X (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)

n/M (Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 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).