The Coronis 3MP-21" 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 MFGD 3621 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 3MP-21" is a display system for medical viewing. It consists of 3 components: MFGD 3621 is a 21.3" grayscale LCD display. BarcoMed Coronis is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal Pro is user-friendly softcopy QA software. The display system can be a single-head system or multi-head system. In the last case it -ontains multiple displays and display controller boards.

MFGD 3621 is a 21.3" grayscale LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.

AI/ML Overview

The provided 510(k) summary for the Barco Coronis 3MP-21" and MFGD 3621 display systems does not contain explicit acceptance criteria or a study outlining the device's performance against such criteria.

This type of submission primarily focuses on establishing substantial equivalence to a predicate device. For display systems like these, the demonstration of substantial equivalence often relies on technical specifications and functional equivalence rather than clinical performance studies with specific metrics like accuracy, sensitivity, or specificity. The documents state that "Any difference between both devices does not affect safety or efficacy," implying that the technical characteristics are sufficiently similar to the predicate to not warrant new performance data.

Therefore, many of the requested sections (sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for a medical display system.

Here's an attempt to structure the answer based on the information available:

Acceptance Criteria and Study for Coronis 3MP-21" and MFGD 3621

The provided 510(k) summaries for the Barco Coronis 3MP-21" and MFGD 3621 do not include explicit acceptance criteria in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) or a specific clinical study designed to test against such criteria. The regulatory pathway chosen for these devices is substantial equivalence to a predicate device, meaning the focus is on demonstrating that the new device is as safe and effective as a legally marketed product.

Instead of performance metrics, the acceptance criteria are implicitly defined by the technical and functional characteristics being substantially equivalent to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion/Parameter	Acceptance Criteria (Implicit)	Reported Device Performance
Coronis 3MP-21"
Technical Equivalence	The Coronis 3MP-21" system's components (display, controller, software) must perform functions comparable to its predicate device (Coronis 3MP Medical flat panel display system) and not introduce new safety or efficacy concerns.	- Display (MFGD 3621): 21.3" grayscale LCD, 2048 x 1536 pixels resolution. - Controller (BarcoMed Coronis): Fast, high-resolution, 10-bit in, 10-bit out LUT (1024 gray levels). - Software (MediCal Pro): Automated image quality assurance, calibration. - Comparison to Predicate: "Compared to the predicate device, the display of the Coronis 3MP-21" system has a different LCD panel with somewhat larger screen size. The other components of the system are the same." - Conclusion: "Any difference between both devices does not affect safety or efficacy."
Functional Equivalence	The Coronis 3MP-21" system must serve the same general function as its predicate.	"The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use."
Intended Use Equivalence	The intended use of the Coronis 3MP-21" must be the same as its predicate.	"The Coronis 3MP-21" 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." (Identical to predicate's stated intended use characteristics).
MFGD 3621 Display
Technical Equivalence	The MFGD 3621 display must perform functions comparable to its predicate device (MFGD 2320 20-inch 2 Megapixel grayscale display) and not introduce new safety or efficacy concerns.	- Display (MFGD 3621): 21.3" grayscale LCD, 2048 x 1536 pixels resolution. - Software (MediCal Pro): Automated image quality assurance, calibration. - Comparison to Predicate: "Compared to the predicate device, the MFGD 3621 display has a different LCD panel with larger screen size and higher resolution." - Conclusion: "Any difference between both devices does not affect safety or efficacy."
Functional Equivalence	The MFGD 3621 display must serve the same general function as its predicate.	"The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use."
Intended Use Equivalence	The intended use of the MFGD 3621 must be the same as its predicate.	"The MFGD 3621 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." (Identical to predicate's stated intended use characteristics, though the predicate's intended use isn't explicitly listed in this document, it's inferred by the substantial equivalence claim).

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

Not applicable / Not provided. No specific clinical test set or data provenance is mentioned as this is a technical substantial equivalence submission for a display system, not a diagnostic algorithm.

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

Not applicable / Not provided. Ground truth establishment by experts for a test set is not detailed in this type of submission for a display system.

4. Adjudication Method for the Test Set

Not applicable / Not provided. Adjudication methods are typically for clinical performance studies, which are not described here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study was not described. This type of study is more relevant for AI diagnostic algorithms where human reading performance is being measured and compared with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No. A standalone performance study of an algorithm is not applicable, as these are medical display systems, not diagnostic algorithms. Their "performance" is primarily defined by their technical display capabilities and image quality, which is compared to predicate devices.

7. Type of Ground Truth Used

Not applicable / Not provided directly. In the context of a display system, "ground truth" would relate to the display's ability to accurately render images according to industry standards, but this is assessed through technical specifications and comparison rather than a clinical ground truth like pathology or outcomes data. The "ground truth" for substantial equivalence is the predicate device's established safety and efficacy.

8. Sample Size for the Training Set

Not applicable / Not provided. There is no mention of a training set as this is not an AI algorithm requiring one.

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

Not applicable / Not provided. No training set is described.

In summary: The 510(k) submission for the Barco Coronis 3MP-21" and MFGD 3621 relies on demonstrating technical and functional equivalence to legally marketed predicate display devices. The acceptance criteria are implicit in aligning with the predicate's established performance, and formal clinical studies with specific performance metrics are not presented as part of this submission for a medical display system.

Summary

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510(k) Summary In accordance with 21 CFR 807.92

K052429

1. Date of preparation

SEP 1 5 2005

September 01, 2005

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 3MP-21" .
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 3MP Medical flat panel display system .
510(k) number: K013922 .
Manufacturer: Barco NV .

6. Device description

Coronis 3MP-21" is a display system for medical viewing. It consists of 3 components:

MFGD 3621 is a 21.3" grayscale LCD display. BarcoMed Coronis is a fast high-resolution display controller board that plugs into a PACS workstation computer. MediCal Pro is user-friendly softcopy QA software.

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

7. Intended use

"The Coronis 3MP-21" 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.

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8. Summary of technological characteristics

The device consists of three components:

One 3-megapixel flat panel display (MFGD 3621) .
One 10-bit display controller board (BarcoMed Coronis) .
MediCal Pro software .

The flat panel display has a resolution of 2048 x 1536 pixels. It can be used in landscape and portrait mode.

The display controller board is an ultra-high speed board with a 10-bit in, 10-bit out look-up table, providing 1024 simultaneous levels of gray.

The MediCal Pro software provides fully automated image quality assurance. It maintains and logs display viewing performance, automates QA tasks and sets up system calibration.

Compared to the predicate device, the display of the Coronis 3MP-21" system has a different LCD panel with somewhat larger screen size. The other components of the system 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 3MP-21" is substantially equivalent to the predicate device, Coronis 3MP Medical flat panel display system.

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 3MP-21" contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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510(k) Summarv In accordance with 21 CFR 807.92

1. Date of preparation

September 01, 2005

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: MFGD 3621
. 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 2320 20-inch 2 Megapixel grayscale display .
. 510(k) number: K033004
. Manufacturer: Barco NV

6. Device description

MFGD 3621 is a 21.3" grayscale LCD display for medical viewing. It is combined with MediCal Pro, a user-friendly softcopy QA software.

7. Intended use

The MFGD 3621 is intended to be used in displaying and viewing digital images for review by crained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

8. Summary of technological characteristics

The flat panel display has a resolution of 2048 x 1536 pixels. It can be used in landscape or

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The MediCal Pro software provides fully automated image quality assurance. It maintains and logs display viewing performance, automates QA tasks and sets up system calibration.

Compared to the predicate device, the MFGD 3621 display has a different LCD panel with larger screen size and higher resolution.

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

9. Conclusion:

The Barco MFGD 3621 is substantially equivalent to the predicate device, MFGD 2320 20-inch 2 Megapixel grayscale display.

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 MFGD 3621 contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines.

Public Health Service

SEP 1 5 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K052429 Trade/Device Name: Coronis 3MP-21" and MFGD 3621 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 1, 2005 Received: September 8, 2005

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.

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.

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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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

2 Enclosures

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INDICATIONS FOR USE

-10(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Coronis 3MP-21"

Indications for Use:

"The Coronis 3MP-21" is intended to be used in displaying and viewing digital images for review The Coronis SF15 15 meenage to se sevices must not be used in primary image diagnosis in mammography.

Prescription Use XX

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Braydon

(Division Sign Division of Reproduc and Radiological Devic 510(k) Number

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INDICATIONS FOR USE

10(k) Number (if known): קבע 52429 -----------------------------------------------------------------------------------------------------------------------------------------

Device Name: MFGD 3621

Indications for Use:

"The MFGD 3621 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 _____________________________________________________________________________________________________________________________________________________________

(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)

Nancy C. Boydon
(Division Sign-Off)

Division of Reproduc 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).