19-inch (48cm) 1.3M Monochrome LCD Monitor MDL1908A is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.

Device Description

MDL1908A is a 19-inch (48cm) 1.3 megapixel Monochrome LCD monitor that supports DVI video signal and provides UXGA (1280 x 1024) resolution for both landscape and portrait display.

AI/ML Overview

The provided text describes a 510(k) submission for a medical display monitor, not a device that processes or analyzes medical images using AI or other algorithms. Therefore, many of the requested criteria such as expert consensus, ground truth, training/test sets, and AI assistance are not applicable to this type of device.

This document focuses on establishing substantial equivalence to a predicate device (another medical monitor) based on physical and performance characteristics typically assessed for displays.

Here's a breakdown of the relevant information from the provided text, and an explanation of why other criteria are not applicable:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a tabulated format for direct comparison like a diagnostic device might. Instead, it implies that the device meets the performance characteristics expected of a 1.3M Monochrome LCD monitor for diagnostic medical image viewing, and that these characteristics are substantially equivalent to its predicate device.

The characteristics of the device itself are:

Acceptance Criteria (Implied)	Reported Device Performance (Characteristics)
Display Type	19-inch (48cm) 1.3M Monochrome LCD Monitor
Resolution	UXGA (1280 x 1024)
Signal Input	Supports DVI video signal
Display Modes	Both landscape and portrait display
Intended Use	Displaying and viewing medical images for diagnosis by trained medical practitioners (excluding digital mammography)
Substantial Equivalence	Shares same characteristics with predicate device ME183L (MDL1812A) (K030272) except for a board, LCD panel, and power supply.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a display monitor, not a diagnostic algorithm or device that analyzes patient data. There is no "test set" of patient data in the context of conventional diagnostic testing for this device. The evaluation would involve technical performance tests of the monitor itself (e.g., brightness, contrast, uniformity, resolution, color accuracy if applicable for color monitors, etc.), not a set of medical images for diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no "ground truth" to establish for a display monitor in the same way there would be for a diagnostic tool. The ground truth for a display is its adherence to technical specifications and display standards (e.g., DICOM Part 14 Grayscale Standard Display Function).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, for the same reasons as points 2 and 3.

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 not an AI-assisted diagnostic tool. No MRMC study would be performed for a medical display monitor in this context. Its purpose is to accurately display images, not to assist in interpreting them directly or to perform AI analysis.

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

Not applicable. This device is purely a display monitor; there is no embedded algorithm for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for a monitor would be its technical specifications and compliance with relevant industry standards (e.g., DICOM Part 14 for grayscale display functions, NEMA display requirements).

8. The sample size for the training set

Not applicable. This device does not use a training set as it's a hardware display and not a learning algorithm.

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

Not applicable. (See point 8).

In summary, the 510(k) for a medical display monitor like the MDL1908A focuses on demonstrating that the device's technical specifications and performance are adequate for its intended use (displaying medical images for diagnosis) and that it is substantially equivalent to a legally marketed predicate device. The criteria typically associated with diagnostic algorithms (AI, ground truth, reader studies) are not relevant here.

Summary

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K072066

510(k) SUMMARY

Submitter Information:	TOTOKU ELECTRIC CO., LTD.300 Oya, UedaNagano 386-0192 JapanAUG 1 4 2007
Contact Person:	Mikio Hasegawa, General ManagerEmail: hasegawam@totoku.co.jpTel:+81.268.34.5469Fax:+81.268.34.5548
Date Prepared:	July 24, 2007
Device Name:	19-inch (48 cm) 1.3M Monochrome LCD Monitor MDL1908A
Common Name:	MDL1908A
Classification Name:	Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System)
Predicate Device:	1.3M Monochrome LCD Monitor MDL1812A (ME183L) (K030272)
Device Description:	MDL1908A is a 19-inch (48cm) 1.3 megapixel Monochrome LCDmonitor that supports DVI video signal and provides UXGA (1280x 1024) resolution for both landscape and portrait display.
Intended Use:	19-inch (48cm) 1.3M Monochrome LCD Monitor MDL1908A isintended to be used in displaying and viewing medical images fordiagnosis by trained medical practitioners. It is not meant to beused for digital mammography.
Substantial Equivalence:	MDL1908A shares the same characteristics with our predicatedevice ME183L (MDL1812A) (K030272) except for a board, LCDpanel, power supply.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 1 4 2007

Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. 300 Ova, Ueda, Nagano, 386-0192 JAPAN

Re: K072066

Trade/Device Name: 1.3M Monochrome LCD Monitor MDL 1908A Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 24, 2007 Received: July 27, 2007

Dear Mr. Hasegawa: :

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 (Premarket Approval), 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.

Image /page/1/Picture/8 description: The image shows a circular logo with the text "1906-2006" at the top. Below the text is a large "DA" in a bold, blocky font. Underneath "DA" is the word "Centennial" in a cursive font. There are three stars at the bottom of the logo.

Protesting and Promoting Public Health

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Page 2 -

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 (OS) 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 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 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 894.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). 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/cdrl/industry/support/index.html.

Sincerely vours.

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K072066

INDICATIONS FOR USE

510(k) Number: Not Known

Device Name: 1.3M Monochrome LCD Monitor MDL1908A Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dwhang 8/14/07

(Division Si (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).