5 MP Medical Monochrome Reference Display, MDM2010-5NC is intended to be used in various kinds of medical images applications including digital mammography system.

Device Description

Medical Display, MDM2010-5NC is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, PACS and digital mammography system.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical display device, the Medical Display, MDM2010-5NC. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than conducting a full clinical study with specific acceptance criteria in the way a novel AI algorithm would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established) are not applicable to this type of device and submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For this medical display, the "acceptance criteria" revolve around its technical specifications being comparable to or meeting the standards for general medical image display and specifically digital mammography. The "reported device performance" is essentially its listed technical capabilities that demonstrate it meets these general requirements and is equivalent to the predicate.

Acceptance Criterion (Implied by equivalence to predicate and intended use)	Reported Device Performance (MDM2010-5NC)
Resolution: Suitable for medical imaging, including digital mammography.	5 megapixels (2560*2048) resolution
Display Type: Monochrome for diagnostic medical images.	Monochrome LCD monitor
Screen Size: Appropriate for display of medical images.	20.1" (diagonal)
Gray Scale: Adjustable for precise diagnostic use.	Adjustable gamma gray scale
Intended Use: For various medical image applications including digital mammography, CT, MRI, HIS, PACS.	Intended to be used in various kinds of medical images applications including digital mammography system.

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

Not Applicable. This is a hardware device (a monitor), not an AI algorithm evaluated on a test dataset of medical images. The evaluation is primarily based on technical specifications and comparison to a predicate device.

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

Not Applicable. See point 2.

4. Adjudication Method for the Test Set

Not Applicable. See point 2.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Readers Improve with AI vs. Without AI Assistance

Not Applicable. This is a medical display, not an AI-powered diagnostic algorithm. There is no AI component or human reader performance study mentioned.

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

Not Applicable. This is a hardware monitor. There is no algorithm to evaluate in standalone mode.

7. The Type of Ground Truth Used

Not Applicable. For this device, the "ground truth" is its technical specifications and compliance with industry standards for medical displays. There isn't a diagnostic "ground truth" in the sense of a disease state.

8. The Sample Size for the Training Set

Not Applicable. No training set is used for a medical display device.

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

Not Applicable. No training set is used for a medical display device.

Study Proving Device Meets Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is the Substantial Equivalence (SE) determination made by the FDA based on the 510(k) submission.

The core of the study is a comparison to a predicate device:

Predicate Device: RadiForce G51 21.3" 5MP Monochrome LCD Monitor by EIZO NANAO CORPORATION. (K042755).
Methodology: The manufacturer (CHILIN TECHNOLOGY CO., LTD.) submitted technical specifications and a justification that their device (MDM2010-5NC) has the "same intended use as the predicate device" and that they "both share similar characteristics except some minor differences which do not raise new questions of safety and effectiveness."
Conclusion: The FDA reviewed these claims and, finding the device substantially equivalent to the legally marketed predicate, allowed it to proceed to market. This means the FDA agreed that the MDM2010-5NC's technical performance and intended use are sufficiently similar to the predicate that it meets the necessary safety and effectiveness standards without requiring a new, extensive clinical trial.

In essence, for this type of device, the "acceptance criteria" are implicitly met by demonstrating that the device is technically comparable to a device already deemed safe and effective for its stated indications for use.

Summary

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K063269

510(K) Summary of Safety and Effectiveness

MAY 2 3 2007

As required by 807.92

DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

Phil Chen CHILIN TECHNOLOGY CO., LTD. No.71, Te Lun Road, Jen Te Hsian, Tainan County 717, Taiwan, R.O.C. Ph: +886-6-279 - 4113 ext. 533 Facsimile: +886-6-249 - 4751

DATE SUMMARY PREPARED 2.

28 June 2006

DEVICE NAME 3.

Trade Name:	Medical Display, MDM2010-5NC
Common Name:	Monochrome LCD Monitor, Monochrome Diagnostic Display, etc.
Classification Name:	System, Image Processing, Radiological (CLASS II CFR 892.2050)

PREDICATE DEVICE 4.

RadiRorce G51 21.3" 5MP Monochrome LCD Monitor by EIZO NANAO CORPORATION. (K042755).

DEVICE DESCRIPTION 5.

DEVICE OF INTEND USE 6.

5 MP Medical Monochrome Reference Display, MDM2010-5NC is intended to be used in various kinds of medical images applications including digital mammography system.

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CONCLUSION 7.

Medical Display, MDM2010-5NC has the same intended use as the predicate device RadiForce G51, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness. The device does not contact with the patient nor does it control any life sustaining device. Therefore we concluded that it is substantially equivalent to RadiForce G51 by EIZO NANAO CORPORATION (K042755).

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Image /page/2/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three curved lines or strokes, possibly representing a stylized human figure or abstract design. The image is in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Chi Lin Technology Co., Ltd. % Mr. Marc M. Mouser CAS Manager, Program Reviewer Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

AAY 2 3 2007

Re: K063269

Trade/Device Name: Medical Display, MDM2010-5NC Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 18, 2007 Received: April 20, 2007

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 (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/2/Picture/10 description: The image is a circular seal or logo. The text "1906-2006" is at the top of the seal. The letters "FDA" are in the center of the seal in a bold, stylized font. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".

High and Possmational

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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 (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 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 yours,

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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Indications for Use

510(k) Number (if known):

Device Name: Medical Display, MDM2010-5NC

Indications For Use: 5 MP Medical Monochrome Reference Display, MDM2010-5NC is intended to be used in various kinds of medical images applications including digital mammography system.

Prescription Use (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)

Nancy C. Brogdon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number __

iii

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).