2MP Medical Color Reference Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

Device Description

Medical Display, MDC2130-2HC is a 21.3" color LCD monitor that displays image for medical use. It provides 2 mega pixel (1600 x 1200) resolution and enable the user to define desired DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2 for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical display device (MDC2130-2HC). However, it does not contain information about acceptance criteria, a specific study proving the device meets those criteria, or any details related to AI performance, ground truth, or sample sizes for a study.

The document is a regulatory submission for a display monitor, which does not typically involve the kind of performance studies (e.g., diagnostic accuracy, reader studies) that AI/CAD devices require. The core of this submission is to demonstrate substantial equivalence to a predicate device based on its intended use and general characteristics, not on a clinical performance study.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred:

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

Acceptance Criteria: Not explicitly stated as performance criteria but inferred from the "sameness" claim to the predicate device. The primary acceptance criterion for a display is likely its ability to accurately and reliably display medical images. This would include resolution, color/grayscale accuracy (e.g., DICOM GSDF adherence), brightness, contrast, and stability over time.
- Inferred Technical Acceptance Criteria:
  - Resolution: 2 mega pixel (1600 x 1200)
  - Gamma settings: DICOM GSDF Gamma settings (1.8, 2.0, 2.2)
Reported Device Performance:
- Resolution: 2 mega pixel (1600 x 1200)
- Gamma settings: Supports DICOM GSDF Gamma settings such as 1.8, 2.0 and 2.2.
- Intended Use: Displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS.

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

Not applicable. This document describes a medical display, not a diagnostic AI device that would undergo a test set evaluation for diagnostic performance. The substantial equivalence argument relies on comparing technical specifications and intended use, not clinical performance data from a patient cohort.

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

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, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a medical display, not an AI device. An MRMC study would not be conducted for this type of product.

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

No. This is a hardware device (display), not an algorithm.

7. The type of ground truth used:

Not applicable. The "ground truth" for a medical display typically relates to objective display characteristics (e.g., a calibrated photometer verifying luminance levels and DICOM GSDF curve adherence) rather than diagnostic outcomes. These tests are typically performed in a lab setting rather than using patient data with expert-established ground truth.

8. The sample size for the training set:

Not applicable. This is a hardware device and does not involve AI model training.

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

Not applicable. See point 8.

Study Proving Acceptance Criteria:

The document states: "Medical Display, MDC2130-2HC has the same intended use as the predicate device MDC1900-1LG, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness."

This statement implies that the "study" proving the device meets acceptance criteria is primarily a comparison to a legally marketed predicate device (MDC1900-1LG), demonstrating "substantial equivalence." The acceptance criteria are essentially met by demonstrating that the new device's technical specifications and performance are comparable to the predicate, and that any differences do not introduce new safety or effectiveness concerns. There is no detailed study methodology or results provided within this summary for either device. Regulatory submissions for display monitors typically include technical specifications and adherence to relevant industry standards (e.g., DICOM Part 14 for grayscale display, resolution standards) rather than clinical performance studies.

Summary

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510(K) Summary of Safety and Effectiveness

As required by 807.92

DEVICE ESTABLISHMENT AND CONTACT PERSON 1.

DEC / 4 2006

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

2. DATE SUMMARY PREPARED

08 September 2006

3. DEVICE NAME

Trade Name: Medical Display, MDC2130-2HC Common Name: Color LCD Monitor, Monochrome Diagnostic Display, etc.

Classification Name: System, Image Processing, Radiological (CLASS II CFR 892.2050)

4. PREDICATE DEVICE

Medical Display - MDC1900-1LG 19" color LCD Monitor by CHILIN TECHNOLOGY CO., LTD. (K061305).

5. DEVICE DESCRIPTION

6. DEVICE OF INTEND USE

Medical Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system

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7. CONCLUSION

Medical Display, MDC2130-2HC has the same intended use as the predicate device MDC1900-1LG, 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 MDC1900-1LG by CHILIN TECHNOLOGY CO., LTD. (K061305).

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Third Party Review Quality Assessment

Section 1 - Submission Information

ﻟﺪﻳﻨﺎ

510(k) No.:	K063579
Third Party Organization:	Underwriters Inc
Third Party's Primary Reviewer(s):	Thomas Huang
ODE/OIVD Division:	ODE
Branch/Team:	DRARD / RADB

Section 2 - 510(k) Decision

Third party recommendation:	SE ✓ NSE ______ Other (specify): ______
ODE/OIVD final decision:	SE ✓ NSE ______ Other (specify): ______

Section 3 - Assessment of Third Party Review

Review Element		Rating (check one)
	Adequate	MinorIssue(s)	MajorIssue(s)
a. Determination of device eligibility for third party review	✓
b. Extent of pre-submission consultation with ODE/OIVD division
c. Organization and format of review documentation
d. Determination of 510(k) administrative completeness (screeningreview)
e. Summary of device characteristics, intended use, and performance(including accessories, if applicable) and reason for 510(k) submission	✓
f. Comparison to legally marketed devices-identification and analysis ofkey similarities and differences
g. Rationale for conclusions and recommendation	✓	✓
h. Use of guidance documents and standards
i. Resolution of 510(k) deficiencies and FDA requests for additionalinformation
j. Scope of reviewer expertise and use of consulting reviewers
k. Other (specify):

Comments (explanation of ratings/issues):

Section 4 - ODE/OIVD Assessur Intornation

Assessed by: Khan

Date: 12-5-06 Tel No: 276

Routing) Division Chp completed assessment (this page only) (o inside from cover of >(0) DMC Town addition page only to Rechen, POS/ODF, Rin 1209, Corp. Blvd. (HF/ 2011

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

DEC 1 4 2006

CHI LIN Technology Co., Ltd. c/o Mr. Marc M. Mouser Sr. Project Engineer, Program Reviewer Underwriter Laboratories, Inc. 2600 N. W. Lake Road CAMAS WA 98607-8542

Re: K063579

Trade/Device Name: Medical Display, MDC2130-2HC Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 13, 2006 Received: November 30, 2006

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/3/Picture/10 description: The image shows a circular logo for the FDA Centennial 1906-2006. The logo features the letters "FDA" in a stylized font, with the word "Centennial" written below. Three stars are placed below the word "Centennial". The logo is surrounded by text that follows the circular shape.

ng and Promoting Public St

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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/cdrlv/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

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, MDC2130-2HC

Indications For Use: 2MP Medical Color Reference Display, MDC2130-2HC is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a 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)

(Division Sign-Off) Division of Reproductive, Abdo 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).