The Nio 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 E-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

Nio 3MP-21" is a display system for medical viewing. It consists of 3 components: E-3621 is a 21" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing. The display system can be a single-head system or multi-head system. In the last case it contains multiple displays and display controller boards.
E-3621 is a 21" grayscale LCD display for medical viewing. It is combined with NioWatch, a userfriendly software that allows to optimize the display for DICOM-compliant viewing.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Barco Nio 3MP-21" and E-3621 display systems, based on the provided 510(k) summary:

It's important to note that this 510(k) pertains to a medical display system, not an AI algorithm. Therefore, many of the typical questions related to AI studies (like sample size for training sets, MRMC studies, or multi-reader performance) are not applicable. The substantial equivalence is demonstrated by comparing the technical characteristics and intended use of the new device to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Acceptance Criteria	Barco Nio 3MP-21" (New Device)	Barco E-3621 (New Device)	Predicate Device: Nio 2MP Medical flat panel display system (K042660)	Predicate Device: MFGD 2320 20-inch 2 Megapixel grayscale display (K033004)
Intended Use	Displaying and viewing digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography.	Displaying and viewing digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography.	Displaying and viewing digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography.	Displaying and viewing digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography.
Components	3-megapixel flat panel display (E-3621), 10-bit display controller (BarcoMed Nio board), NioWatch software	21" grayscale LCD display (standalone, combined with NioWatch software)	2-megapixel flat panel display, display controller, NioWatch software	20-inch 2 Megapixel grayscale display
Display Resolution	2048x1536 pixels (3MP)	2048x1536 pixels (3MP)	2MP (specific resolution not detailed in summary, but assumed lower than 3MP)	2 Megapixel (specific resolution not detailed in summary, but assumed lower than 3MP)
Screen Size	21"	21"	Not specified, but implied to be smaller than 21" with "2MP"	20-inch
Lookup Table (Controller)	8-bit in, 10-bit out, 256 simultaneous shades of gray	Not applicable (standalone display)	8-bit in, 10-bit out, 256 simultaneous shades of gray	Not applicable (standalone display)
Software	NioWatch (optimizes for DICOM, sets display function, test patterns, calibrates, views info)	NioWatch (optimizes for DICOM, sets display function, test patterns, calibrates, views info)	NioWatch	NioWatch
Contact with Patient	No	No	No	No
Control Life Sustaining Devices	No	No	No	No
Backlight Sensor	Yes (part of E-3621 component)	Yes	Not specified (implied to have a front sensor for predicate MFGD 2320)	Assumed to have a front sensor, based on new device having a backlight sensor instead of a front sensor.
Technological Characteristics	"Substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference... does not affect safety or efficacy."	"Substantially equivalent in the areas of technical characteristics, general function, application and intended use. Any difference... does not affect safety or efficacy."

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

This 510(k) is for a medical display system, not an AI algorithm performing diagnostic tasks on medical images. Therefore, there is no "test set" of medical images in the sense of a diagnostic performance study.
The evaluation focuses on the technical specifications and performance of the display hardware and associated software. Data provenance would refer to internal testing and validation of display parameters (e.g., luminance, uniformity, DICOM conformance), which are not detailed in the summary but are standard manufacturer practices for such devices. The origin of such internal data is implicitly from the manufacturer (Barco NV) in Belgium.

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

This question is not applicable. There is no diagnostic "ground truth" established by medical experts for this type of device. The ground truth for display performance would be established through engineering specifications and industry standards (e.g., DICOM Part 14 calibration).

4. Adjudication Method for the Test Set

This question is not applicable due to the nature of the device (medical display system).

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

This question is not applicable. This is not an AI-assisted diagnostic device.

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

This question is not applicable. This is a medical display system, not an algorithm. Its function is to present images for human review.

7. The Type of Ground Truth Used

The ground truth for this device revolves around its technical specifications meeting established industry standards for medical image display (e.g., DICOM Part 14, NEMA XR 21) and safe operation. The "ground truth" is adherence to performance metrics like resolution, luminance, contrast, uniformity, grayscale reproduction accuracy, and stability over time. These are assessed through technical measurements and quality control procedures, rather than clinical outcomes or pathology.

8. The Sample Size for the Training Set

This question is not applicable. This is not an AI algorithm.

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

This question is not applicable. This is not an AI algorithm.

Summary

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K05190L

510(k) Summary In accordance with 21 CFR 807.92

1. Date of preparation

AUG 1 7 2005

July 05, 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: Nio 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: Nio 2MP Medical flat panel display system .
510(k) number: K042660 V �
Manufacturer: Barco NV .

6. Device description

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

E-3621 is a 21" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch is user-friendly software that allows to optimize the display for DICOM-compliant viewing.

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

7. Intended use

"The Nio 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-meqapixel flat panel display (E-3621) .
. One 10-bit display controller (BarcoMed Nio board)
. NioWatch software

The flat panel display has a resolution of 2048x1536 pixels. It can be used in landscape and portrait mode.

The display controller board is an ultra-high speed board with an 8-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray.

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

Compared to the predicate device, the display from the Nio 3MP-21" system has a different LCD panel with somewhat larger screen size and higher resolution. 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 Nio 3MP-21" is substantially equivalent to the predicate device, Nio 2MP 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 Nio 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) Summary In accordance with 21 CFR 807.92

1. Date of preparation

July 05, 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: E-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

E-3621 is a 21" grayscale LCD display for medical viewing. It is combined with NioWatch, a userfriendly software that allows to optimize the display for DICOM-compliant viewing.

7. Intended use

The E-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.

8. Summary of technological characteristics

The flat panel display has a resolution of 2048x1536 pixels. It can be used in landscape on

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portrait mode.

The NioWatch software allows to set the display function, display test patterns, calibrate the display and view additional display information.

Compared to the predicate device, the E-3621 display has a different LCD panel with larger screen size and higher resolution, and contains a backlight sensor instead of a front sensor.

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

9. Conclusion:

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

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K051901

AUG 1 7 2005

Trade/Device Name: Nio 3MP-21 Medical Flat Panel Display System and E-3621 Medical Flat Panel Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: LLZ Dated: July 5, 2005 Received: July 13, 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 (OS) 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) I ms letter will anow you to organization of substantial equivalence of your device to a legally prematics notifiedding - 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 rr you don't if you 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 001:57). I od may overnmentional 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

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

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

Device Name: E-3621

Indications for Use:

"The E-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 XX (Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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 bragdon

(Division Sign Off Division of Reproduct 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).