The MDCC 2121 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Device Description

MDCC 2121 is a 21.3" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

AI/ML Overview

The provided document is a 510(k) summary for the Barco MDCC 2121 display system. It's a pre-market notification to demonstrate substantial equivalence to a predicate device, not a study proving the device meets specific performance criteria through clinical trials or extensive standalone evaluation.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, ground truth establishment, and MRMC studies are not applicable to this type of regulatory submission. This document focuses on demonstrating that the new device (MDCC 2121) is technically similar to an already approved device (MFGD 2621) and therefore does not require a new, full-scale clinical evaluation.

Here's a breakdown of what can be extracted and why other parts are not available in this document:

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

The document does not provide a table of explicit acceptance criteria with quantitative performance metrics. This is because it's a submission for substantial equivalence based on technical characteristics, not a clinical performance study with predefined success/failure thresholds for a new, unproven technology.

Instead, the "performance" is implicitly demonstrated through the statement: "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use."

The relevant technical characteristics mentioned are:

Resolution: 1600x1200 pixels
Panel type: 21.3" color LCD display
Software: MediCal QAWeb Agent for optimization, DICOM-compliant viewing, calibration, and display test patterns.

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 510(k) summary does not describe a test set or data provenance in the context of a clinical performance study. The "test" for substantial equivalence is a comparison of technical specifications and intended use against a predicate device.

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 test set or ground truth established in this document for the purpose of evaluating diagnostic performance. The ground truth for this submission is based on the established safety and efficacy of the predicate device.

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

Not applicable. No test set requiring outcome adjudication is described.

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. The MDCC 2121 is a display system, not an AI-powered diagnostic tool. MRMC studies are used for evaluating AI or new diagnostic methods, which is beyond the scope of this device's intended use and the nature of this 510(k) submission.

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

Not applicable. The MDCC 2121 is a display system and does not involve an algorithm that performs diagnostic functions independently. It is explicitly "intended to be used in displaying and viewing digital images for review by trained medical practitioners," indicating human-in-the-loop operation.

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

Not applicable. Ground truth for diagnostic performance is not relevant for this regulatory submission, which focuses on the display's technical functionality and equivalence. The "ground truth" for the submission is the predicate device's previously established safety and efficacy for its intended use.

8. The sample size for the training set

Not applicable. The MDCC 2121 is a display system and does not employ machine learning or AI that would require a training set.

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

Not applicable. As there's no training set, there's no ground truth to establish for one.

Summary of what can be extracted from the document:

This 510(k) summary describes a display system (MDCC 2121) and argues for its substantial equivalence to a predicate device (MFGD 2621) based on technical characteristics and intended use. It explicitly states it is for "displaying and viewing digital images for review by trained medical practitioners" and "must not be used in primary image diagnosis in mammography." The document does not contain information about clinical acceptance criteria, performance studies, sample sizes, or ground truth in the context of diagnostic accuracy, as these are not required for demonstrating substantial equivalence for this type of device.

Summary

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510(K) SUMMARY

In accordance with 21 CFR 807.92

1. Date of preparation

June 28, 2006

2061928

SEP - 5 2006

2. Company information

BarcoView 35 President Kennedypark B-8500 Kortrijk, Belgium Tel. +32-(0)56-233-211 Fax +32-(0)56-233-457

3. Contact person

Lieven De Wandel Official correspondent

4. Device information

. Trade name: MDCC 2121
. Common name: Display system, medical image workstation, and others
Classification name: System, Image Processing .
. Classification number: 21 CFR 892.2050 / Procode 90LLZ

5. Predicate device

. Name: MFGD 2621
. 510(k) number: K052403
. Manufacturer: Barco NV

6. Device description

MDCC 2121 is a 21.3" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

7. Intended use

"The MDCC 2121 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

8. Summary of technological characteristics

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The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape or portrait mode.

The MediCal QAWeb Agent software allows to set the display function, display test patterns, calibrate the display and view additional display controller information.

Compared to the predicate device, the MDCC 2121 display has a different LCD panel, other electronic and mechanical parts. The basic specifications and functions, however, are the same.

The device does not come into contact with the patient. It does not control any life sustaining devices either.

9. Conclusion:

The Barco MDCC 2121 is substantially equivalent to the predicate device, MFGD 2621. The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use.

Any difference between both devices does not affect safety or efficacy.

The 510(k) Pre-Market Notification for the Barco MDCC 2121 contains adequate information and data to enable FDA – CDRH to determine substantial equivalence to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three heads or faces, with wavy lines below the figures.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP - 5 2006

Mr. Lieven De Wandel Official Correspondent Barco - Medical Imaging Systems President Kennedypark 35 B-8500 Kortrijk BELGIUM

Re: K061928

Trade/Device Name: MDCC 2121 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 28, 2006 Received: July 7, 2006

Dear Mr. De Wandel:

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 black and white circular logo. The logo contains the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are in the center of the logo. There are four stars at the very bottom of the logo.

Protecting 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 (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 predicated 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/cdrh/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

ρ(k) Number (if known): K061928

Device Name: MDCC 2121

Indications for Use:

*The MDCC 2121 is intended to be used in displaying and viewing digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

Prescription Use XX

(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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seemann

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