The Color Nio 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 E-2320 C 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

Color Nio 2MP is a display system for medical viewing. It consists of 3 components: E-2320 C is a 20.1" color LCD display. BarcoMed 2MP2CFe 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-2320 C is a 20.1" color 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

This document is a 510(k) premarket notification for the "Color Nio 2MP" and "E-2320 C" display systems, seeking to demonstrate substantial equivalence to predicate devices. It does not contain information about a study proving device performance against acceptance criteria in the typical sense of a clinical trial or algorithm performance study.

These are display devices, and the "acceptance criteria" here relate to their technical specifications aligning with those of legally marketed predicate devices, rather than clinical performance metrics like sensitivity or specificity for a diagnostic task.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test/training sets, training set sample size, ground truth establishment for training set) are not applicable to this type of submission.

Here's a breakdown of the available information interpreted in the context of a display device submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Display Devices)	Reported Device Performance (Summary of Technological Characteristics)
Color Nio 2MP (compared to Nio 2MP Medical flat panel display system K042660)
Display Type & Capability	Color LCD Panel capable of 1600x1200 pixels, landscape/portrait mode. (Predicate was grayscale, but same size/resolution).
Resolution	1600x1200 pixels
Controller Board Type	24-bit color display controller board (BarcoMed 2MP2CFe). (Predicate was grayscale board).
Software Functionality	NioWatch software for display function, test patterns, calibration, display information.
Intended Use	Displaying and viewing digital images for review by trained medical practitioners (not primary image diagnosis in mammography).
E-2320 C (compared to MFCD 2320 K040158)
Display Type & Capability	Color LCD Panel capable of 1600x1200 pixels, landscape/portrait mode.
Resolution	1600x1200 pixels
Software Functionality	NioWatch software for display function, test patterns, calibration, display information.
Sensor Type	Backlight sensor (Predicate had front sensor).
Intended Use	Displaying and viewing digital images for review by trained medical practitioners (not primary image diagnosis in mammography).

Study Proving Device Meets Acceptance Criteria:

The document describes a substantial equivalence determination rather than a traditional study with acceptance criteria and performance metrics. The "study" is, in essence, the technical comparison presented in the 510(k) summary.

The core of the "proof" is the comparison of technological characteristics between the new devices (Color Nio 2MP and E-2320 C) and their respective predicate devices (Nio 2MP Medical flat panel display system K042660 and MFCD 2320 K040158). The manufacturer asserts, and the FDA concurs, that "Any difference between both devices does not affect safety or efficacy."

Specifics from your numbered list:

Sample size used for the test set and the data provenance: Not applicable. This is a technical comparison for display devices, not a study involving patient data or a test set in the clinical sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical interpretation is not relevant for this type of device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the reasons above.
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. These are display devices, not AI algorithms, and no MRMC study is mentioned or relevant to their substantial equivalence.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. These are display hardware and associated software, not algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this submission revolves around the technical specifications and performance of the display panel and controller, relative to a legally marketed predicate device, to ensure it continues to adequately display medical images without compromising safety or efficacy.
The sample size for the training set: Not applicable. No algorithms were "trained" in this submission.
How the ground truth for the training set was established: Not applicable. No algorithms were "trained" in this submission.

Summary

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1. Date of preparation

NOV 1 6 2005

October 19, 2005

2. Company information

BarcoView 35 President Kennedypark B-8500 Kortriik, 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: Color Nio 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: Nio 2MP Medical flat panel display system .
510(k) number: K042660 .
Manufacturer: Barco NV .

6. Device description

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 Color Nio 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.

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8. Summary of technological characteristics

The device consists of three components:

One 2-megapixel flat panel display (E-2320 C) .
One 24-bit color display controller (BarcoMed 2MP2CFe 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 a 32-bit in, 32-bit out look-up table.

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 Color Nio 2MP system has a color instead of grayscale LCD panel, while screen size and resolution are identical. The display controller board is a color board instead of a grayscale board.

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

9. Conclusion:

The Barco Color Nio 2MP 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 Color Nio 2MP 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

K052958

1. Date of preparation

October 19, 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-2320 C .
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: MFCD 2320 .
510(k) number: K040158 .
Manufacturer: Barco NV .

6. Device description

E-2320 C is a 20.1" color 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-2320 C 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-2320 C display 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-2320 C is substantially equivalent to the predicate device, MFCD 2320.

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-2320 C contains adequate information and rne 520(K) Ne France FDA - CDRH to determine substantial equivalence to the predicate device.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its body, representing the three branches of government. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

NOV 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lieven De Wandel BARCOVIEW Medical Imaging Systems 35 President Kennedypark 8500 Kortrijk BELGIUM

Re.: K052958 Trade/Device Name: Color Nio 2MP and E-2320 C Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: LLZ Dated: October 19, 2005 Received: October 21, 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 (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 (PMA), it may be subject to 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) I mis letter will and in you to oogin tuding of substantial equivalence of your device to a legally prematice notification: "The Paris 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 Also, production other general information on your responsibilities under the Act from the 60 : 77). I Canal 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

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): المحمد عدد_

Device Name: Color Nio 2MP

Indications for Use:

*The Color Nio 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.

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 Gordon

(Division Sign-Of Division of Reproductive, A and Radiological Devices 510(k) Number

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INDICATIONS FOR USE

10(k) Number (if known): مكتوك كلا :

Device Name: E-2320 C

Indications for Use:

"The E-2320 C 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)

(21 CFR 801 Subpart C)

ADD/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. Burleson

(Division Sign-Of Division of Reproductive, Al : Radiolomanal Devices Cik) 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).