The Coronis 2MP 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.
The MDCG 2121-CB 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

Coronis 2MP is a display system for medical viewing. It consists of 3 components:
MDCG 2121-CB is a 21.3" grayscale LCD display. BarcoMed Coronis PCIe is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control.
The display system can be a single-head system or multi-head system. In the last case it ntains multiple displays and display controller boards.
The device consists of three components:
. One 2-megapixel flat panel display (MDCG 2121-CB)
. One 10-bit display controller (BarcoMed Coronis PCIe board)
. MediCal QAWeb Agent software
The flat panel display has a resolution of 1600x1200 pixels. It can be used in landscape and portrait mode.
The BarcoMed Coronis PCIe display controller board is an ultra-high speed board with a 10-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray.
The MediCal QAWeb Agent software allows to set the display function, display test patterns. calibrate the display and view additional display controller information.

AI/ML Overview

This 510(k) submission (K061926) for the Barco Coronis 2MP is a substantial equivalence claim to a predicate device (Coronis 2MP-21", K052403). Therefore, it does not present a standalone study with acceptance criteria and device performance as would be seen in a de novo submission. Instead, the submission focuses on demonstrating that the new device has "substantially equivalent" characteristics to the predicate device, implying that the acceptance criteria met by the predicate device are implicitly met by the new device.

The document states: "Any difference between both devices does not affect safety or efficacy." This suggests that the performance of the new device is expected to be maintained at a level equivalent to the predicate, which FDA had previously cleared.

Here's an breakdown based on the provided text, addressing your questions to the best of my ability given the nature of a substantial equivalence submission:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence, the document does not explicitly state specific acceptance criteria or report a formal study showing device performance against those criteria in the way a new device might. Instead, the "acceptance criteria" are implied to be the performance and safety characteristics of the predicate device (Coronis 2MP-21", K052403). The "reported device performance" is the statement that the new device's basic specifications and functions are the same as the predicate.

Acceptance Criteria (Implied from Predicate)	Reported Device Performance (Coronis 2MP)
Functionality as a medical display system for viewing digital images (excluding mammography).	Functions as a display system for medical viewing.
Resolution of 1600x1200 pixels.	Flat panel display has a resolution of 1600x1200 pixels.
10-bit color depth (or grayscale equivalent).	10-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray.
Ability to be used in landscape and portrait modes.	Can be used in landscape and portrait mode.
Features for display function, test patterns, calibration, and QA control.	MediCal QAWeb Agent software allows setting display function, display test patterns, calibrating the display, and viewing additional display controller information.
Safety and efficacy equivalent to the predicate device.	"Any difference between both devices does not affect safety or efficacy."

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

This information is not provided in the document because a specific clinical or performance evaluation "test set" in the traditional sense was not performed for this substantial equivalence submission. The comparison is primarily based on the technological characteristics and specifications of the new device against the predicate.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided. Ground truth establishment by experts is typically part of studies involving diagnostic performance, which is not the focus of this 510(k) for a display system. The "ground truth" here is essentially the established performance and safety of the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable/provided as there was no formal "test set" and expert adjudication described in the submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the diagnostic impact of AI or new imaging techniques on human readers, which is not the purpose of this display system 510(k). The device itself is a display, not a diagnostic algorithm.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone performance study in the context of an algorithm or diagnostic tool was not done. The device is a display system, not an algorithm. Its performance is evaluated based on its technical specifications and functionality as a display.

7. The Type of Ground Truth Used

The "ground truth" for this substantial equivalence claim is the established performance and safety characteristics of the predicate device (Coronis 2MP-21", K052403). The new device is compared against these known characteristics to demonstrate equivalence.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. Display systems typically do not involve "training sets" in the context of machine learning or AI algorithms. The design and manufacturing processes are likely guided by engineering specifications and industry standards.

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

This information is not provided and is not applicable for the reasons stated in point 8.

Summary

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Kio/926

510(K) SUMMARY

In accordance with 21 CFR 807,92

1. Date of preparation

June 28, 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: Coronis 2MP
. 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: Coronis 2MP-21"
. 510(k) number: K052403
. Manufacturer: Barco NV

6. Device description

Coronis 2MP is a display system for medical viewing. It consists of 3 components:

MDCG 2121-CB is a 21.3" grayscale LCD display. BarcoMed Coronis PCIe is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control.

The display system can be a single-head system or multi-head system. In the last case it ntains multiple displays and display controller boards.

7. Intended use

"The Coronis 2MP 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.

AUG 1 8 2006

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8. Summary of technological characteristics

The device consists of three components:

. One 2-megapixel flat panel display (MDCG 2121-CB)
. One 10-bit display controller (BarcoMed Coronis PCIe board)
. MediCal QAWeb Agent software

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

The BarcoMed Coronis PCIe display controller board is an ultra-high speed board with a 10-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray.

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 display from the Coronis 2MP system has a different LCD panel, other electronic boards and other mechanical parts. The software is a new version. However, the basic specifications and functions of all the parts 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 Coronis 2MP is substantially equivalent to the predicate device, Coronis 2MP-21",

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 Coronis 2MP 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 U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized design of three overlapping human figures.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG ] 8 2006

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

Re: K061926

Trade/Device Name: MDCG-2121-CB 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 logo. The logo is circular and contains the text "1906-2006" at the top. Below the text is the abbreviation "PA" in large, bold letters. Underneath the abbreviation is the word "Centennial" in a smaller font. There are three stars below the word "Centennial."

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 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. Hodgdon

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: MDCG 2121-CB

Indications for Use:

"The MDCG 2121-CB 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 R. Logemann

(Division Sign-Off) 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).