The Nio 2MP-20" is intended to be used in displaying digital images for review by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.

"The E-2620 S 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 2MP-20" is a display system for medical viewing. It consists of 3 components: E-2620 S is a 20.1" 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 iast case it contains multiple displays and display controller boards.

E-2620 S is a 20.1" grayscale LCD display for medical viewing. It is combined with NioWatch, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

AI/ML Overview

The provided 510(k) summary does not contain information about specific acceptance criteria, a study that proves the device meets such criteria, or detailed performance metrics.

This submission is a "Substantial Equivalence" determination for a medical display system, not a clinical performance study. The FDA evaluates these types of devices based on their equivalence to a predicate device already on the market, focusing on similar technological characteristics, intended use, and a demonstration that any differences do not affect safety or efficacy.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable or available in submitted document.

Here's a breakdown of what can be gleaned from the document given its nature:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. The document does not provide specific quantitative acceptance criteria or detailed performance metrics from a study that evaluates the device against such criteria. The device is a display system, and its "performance" is primarily assessed by its technical specifications and its ability to display digital images for review, similar to its predicate.

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Technological Characteristics (as per substantial equivalence)	Equivalent to predicate device (Nio 2MP Medical flat panel display system for Nio 2MP-20"; MFGD 2320 20-inch 2 Megapixel grayscale display for E-2620 S) in areas of technical characteristics, general function, application, and intended use.	Nio 2MP-20": Utilizes a different LCD panel but maintains identical screen size and resolution (1600x1200 pixels) as the predicate. Other components (BarcoMed Nio board, NioWatch software) are the same. E-2620 S: Contains a backlight sensor instead of a front sensor compared to the predicate, but their panels are identical. Resolution is 1600x1200 pixels.
Safety and Efficacy Impact (as per substantial equivalence)	No effect on safety or efficacy.	Any differences between the new devices and their respective predicates were determined not to affect safety or efficacy.
Intended Use	Display digital images for review by trained medical practitioners. Not for primary image diagnosis in mammography.	The intended use statements for both Nio 2MP-20" and E-2620 S explicitly state this.

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

Not applicable. This is not a study involving a test set of medical images or patient data. The evaluation is based on technical specifications and comparison to a predicate device.

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

Not applicable. There is no specific "ground truth" derived from expert consensus on medical images because this is a technical equivalence submission for a display device.

4. Adjudication method for the test set

Not applicable. No test set of medical cases was used.

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. No MRMC study was conducted. These devices are display systems, not AI-powered diagnostic tools. There is no "AI assistance" being evaluated.

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

Not applicable. These are display devices, not algorithms, and therefore standalone performance of an algorithm is not relevant.

7. The type of ground truth used

Not applicable. As this is not a study evaluating diagnostic performance on medical images, the concept of "ground truth" in the typical clinical study sense (pathology, expert consensus, outcomes data) does not apply. The "truth" in this context is the technical specifications and functional equivalence to the predicate device.

8. The sample size for the training set

Not applicable. As this is a medical display device and not an AI algorithm, there is no "training set" in the context of machine learning.

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

Not applicable. See point 8.

Summary

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510(k) Summary In accordance with 21 CFR 807.92

K 052276

SEP 2 1 2005

1. Date of preparation

August 18, 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

1. Device information

Trade name: Nio 2MP-20" .
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 .
. Manufacturer: Barco NV

6. Device description

Nio 2MP-20" is a display system for medical viewing. It consists of 3 components:

E-2620 S is a 20.1" 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 iast case it contains multiple displays and display controller boards.

7. Intended use

"The Nio 2MP-20" is intended to be used in displaying 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 2-megapixel flat panel display (E-2620 S) .
One 10-bit display controller (BarcoMed Nio board) .
NioWatch software .

The flat panel display has a resolution of 1600x1200 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 of the Nio 2MP-20" system has a different LCD panel, while screen size and resolution are identical. 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 2MP-20" 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 2MP-20" 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

August 18, 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-2620 S .
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-2620 S is a 20.1" grayscale LCD display for medical viewing. It is combined with NioWatch, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

7. Intended use

"The E-2620 S 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 1600x1200 pixels. It can be used in landscape or

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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-2620 S display contains a backlight sensor instead of a front sensor, while their panels are identical.

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

9. Conclusion:

The Barco E-2620 S is substantially equivalent to the predicate device, MFGD 2320 20-inch 2 Meqapixel 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-2620 S 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 a stylized drawing of a bird in flight. The bird is depicted with simple, curved lines, giving it a minimalist and modern appearance. To the left of the bird, there is a curved line of text that appears to be part of the overall design, possibly indicating a name or title associated with the image.

Public Health Service

SEP 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MI) 20050

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

Re: K052276 Trade/Device Name: Nio 2MP-20" and E-2620 S Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: LLZ Dated: August 18, 2005 Received: August 30, 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. Hogdon

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: Nio 2MP-20"

Indications for Use:

"The Nio 2MP-20″ is intended to be used in displaying 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)

Nancy i broadon
(Division Sign-Off)

Division of Reproductive, Abdo and Radiological Devices 510(k) Number

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INDICATIONS FOR USE

10(k) Number (if known): KoS2276______________________________________________________________________________________________________________________________________________

Device Name: E-2620 S

Indications for Use:

"The E-2620 S 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

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy bradon

(Division Sign-Off) Division of Reproductive, Abe and Radiological Device 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).