The device is intended to be used to as a tool in displaying and viewing digital images view and analyses by trained medical practitioner. The device is not specified for digital mammography system.

Device Description

The MMD-3213M LCD monitors are displays for medical image viewing. MMD-3213M provides 3 mega pixel resolution. The PACSmate MMD-3213M is a high performance, 3 Megapixel medical grade monochrome LCD monitors designed for exacting needs for diagnostics professionals that provide clear and sharp images with resolutions of up to 2048 x 1536 pixels, 600 cd/m2 brightness and 700:1 contrast ratio, making it ideal for diagnosing detailed medical graphics. Also uses a DVI digital interface offering compatibility with the latest digital standards.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical display device, the PACSmate MMD-3213M monitor. However, it does not contain the detailed performance study information, acceptance criteria, or ground truth establishment relevant to the questions asked.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (EIZO RadiForce GS320) based on intended use, construction, function, safety, operating environmental conditions, and effectiveness. It mentions "Performance Testing" but only states: "The performance test results for the PACSmate LCD monitor demonstrated that the device meets its intended use specifications and therefore meets the requirements necessary for its intended use as a displayer for medical image." It does not provide the specific acceptance criteria or the actual results of these performance tests.

Therefore, I cannot populate the table or answer most of your specific questions based on the provided text.

Here's what can be extracted and what cannot:

1. Table of acceptance criteria and the reported device performance:

Cannot be provided from the text. The document states "device meets its intended use specifications" but does not define these specifications or provide quantitative performance metrics.

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

Cannot be provided from the text. There is no mention of a "test set" in the context of image analysis or diagnostic performance. The performance testing likely refers to technical specifications of the monitor itself (e.g., brightness, contrast, resolution) rather than clinical image interpretation studies.

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

Cannot be provided from the text. No ground truth establishment is described, as the device is a display monitor, not an AI diagnostic algorithm.

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

Cannot be provided from the text. Not applicable for a display monitor's performance testing described here.

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:

Cannot be provided from the text. Not applicable, as this is a medical display, not an AI-powered diagnostic tool. The document focuses on the monitor's technical compliance and substantial equivalence.

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

Cannot be provided from the text. Not applicable; it's a monitor.

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

Cannot be provided from the text. Not applicable.

8. The sample size for the training set:

Cannot be provided from the text. Not applicable; this is a display monitor, not an AI algorithm.

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

Cannot be provided from the text. Not applicable.

In summary, the provided document describes the regulatory approval of a medical display monitor based on its technical specifications and substantial equivalence to a predicate device. It does not include information about clinical studies, diagnostic performance, expert review, or ground truth establishment, which are typical for AI-based diagnostic devices.

Summary

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K082496

510(k) Summary

SEP 0 9 2008

[As required by section 807.92(c)]

1. Submitter: ICP electronics Inc. 3F, No.22 Chung-Hsing Road, Shi-Chi City, Taipei Hsien 221, Taiwan.
1. Official Correspondent: Yvonne Chen (Ms.)
1. Date of 510(k) Submittal: 1. February, 2008
1. Device Trade Name PACSmate MMD-3213M monitor
1. Common Name: LCD monitor
1. Classification Name: Medical displays were classified in class II (21 CFR 892.2050)
1. Device Product Code: LLZ
1. Predicate Device: Manufacturer: EIZO NANAO CORPORATION Device name: Monochrome LCD monitor Model name: RadiForce GS320 510(k) No .: K062053
1. Device Description:

The MMD-3213M LCD monitors are displays for medical image viewing. MMD-3213M provides 3 mega pixel resolution.

10.Intended Use:
The device is intended to be used to as a tool in displaying and viewing digital images view and analyses by trained medical practitioner. The device is not specified for digital mammography system.
1. Technological Characteristics:
  The PACSmate MMD-3213M is a high performance, 3 Megapixel

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medical grade monochrome LCD monitors designed for exacting needs for diagnostics professionals that provide clear and sharp images with resolutions of up to 2048 x 1536 pixels, 600 cd/m2 brightness and 700:1 contrast ratio, making it ideal for diagnosing detailed medical graphics. Also uses a DVI digital interface offering compatibility with the latest digital standards.

12.Performance Testing:
The performance test results for the PACSmate LCD monitor demonstrated that the device meets its intended use specifications and therefore meets the requirements necessary for its intended use as a displayer for medical image.
1. Substantial Equivalence to Predicate Device:
  PACSmate MMD-3213M is substantially equivalent to RadiForce GS320. MMD-3123M employs the maximum resolution values same as that of RadiForce GS320. Comparison table of the principal characteristics of two devices is shown in the Section I-2 and specification data for the system monitor is included in Section II.
14.Conclusion:
In terms of intended use, construction, function, safety, operating environmental conditions, and effectiveness of the PACSmate MMD-3213M monitor is substantially equivalent to the predicate device used for this application.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 0 9 2008

IEI Technology Corporation % Mr. Morten Simon Christensen Staff Engineer & FDA Accredited Person Program Coordinator, Program Reviewer Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230

Re: K082496

Trade/Device Name: PACSmate MMD-3213M Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 18, 2008 Received: August 29, 2008

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.

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 i 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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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). 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 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.

Vogue Mr. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image contains a handwritten word that appears to be "Kosaya96". The writing is in black ink on a white background. The letters are connected, and the numbers are written in a similar style to the letters.

Indications for Use

510(k) Number (if known): Not known

Device Name: PACSmate MMD-3213M monitor

Indications For Use:

The device is intended to be used to as a tool in displaying and viewing digital images view and analyses by trained medical practitioner. The device is not specified for digital mammography system.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use (Part 21 CFR 801 Subpart D)

(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)
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(Division Sign-i)
Division of Repro 'uctive, Abdominal and
Radiological Devs s
510(k) Number	K082494

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).