The Nio 5MP-21″ is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. The Nio 5MP-21", containing the display MDNG-5121 CB, the software NioWatch and the graphic board BarcoMed Nio, will be marketed as separate device.

Device Description

Nio 5MP-21" is a display system for medical viewing. It consists of 3 components: MDNG-5121 CB is a 21.3" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch 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 contains multiple displays and display controller boards.

AI/ML Overview

This submission, K062621, describes the Barco Nio 5MP-21" display system, which is intended for displaying digital images, including digital mammography, for review and analysis by trained medical practitioners. The document states that the device is substantially equivalent to existing predicate devices (Coronis 5MP and MFGD 5421). The submission does not provide specific acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical performance study for an AI/CADe device.

Instead, this 510(k) summary focuses on demonstrating that the new device has "substantially equivalent" technological characteristics, general function, application, and intended use as its predicate devices, and that any differences do not affect safety or efficacy. This is a common approach for display systems where the primary concern is the accurate and consistent rendering of medical images, rather than algorithmic detection or diagnosis.

Therefore, the requested information about acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI/CADe systems, is not applicable to this 510(k) submission for a medical display system. The "study" here is essentially a technical comparison and declaration of substantial equivalence to a legally marketed predicate device.

However, based on the information provided, here's how some of your questions can be addressed in the context of this submission:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, explicit "acceptance criteria" and "reported device performance" in the context of clinical accuracy (like sensitivity, specificity, AUC) are not provided for this display system. The acceptance criteria for a display system are typically related to its technical specifications matching or being equivalent to the predicate, ensuring it accurately displays images without introducing errors.

Acceptance Criteria (Implied from Submission)	Reported Device Performance (from Submission)
Technological Characteristics:
- Resolution	- 2560x2048 pixels (for MDNG-5121 CB display)
- Shades of Gray/LUT	- 8-bit in, 10-bit out lookup table, providing 256 simultaneous shades of gray (for BarcoMed Nio board)
- Display Panel	- Uses the same LCD panel as the predicate device (Coronis 5MP / MFGD 5421)
- Software Functionality (QA/Calibration)	- NioWatch software allows setting test patterns, calibrating the display, and viewing display/controller info. (Note: Acknowledged lower functionality compared to predicate's accompanying software, but "basic specifications and functions... are the same" and differences "do not affect safety or efficacy.")
General Function/Application:
- Display digital images	- Intended for displaying digital images, including digital mammography.
- Review and analysis by medical practitioners	- Stated purpose.
Safety and Efficacy:
- No adverse impact on safety or efficacy	- "Any difference between both devices does not affect safety or efficacy."
- Does not come into contact with patient	- Device description explicitly states this.
- Does not control life-sustaining devices	- Device description explicitly states this.
Substantial Equivalence:	- "The Barco Nio 5MP-21" is substantially equivalent to the predicate device, Coronis 5MP." - "The Barco MDNG-5121 CB is substantially equivalent to the predicate device, MFGD 5421." - "The new and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application and intended use."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. This is a medical display system, not an AI/CADe device that processes patient data for diagnostic output requiring a "test set" of images or patient data. The "testing" involves technical verification against specifications and comparison to predicate devices, not a clinical data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. See point 2. Ground truth establishment with experts is relevant for diagnostic or AI/CADe devices, not for a display system.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 2. No test set requiring expert adjudication is mentioned.

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. This is a display system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of device.

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

Not Applicable. This device does not have an algorithm that performs a standalone diagnostic or assistive function in the absence of a human reader.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable. For a display system, the "ground truth" would relate to its technical performance (e.g., luminance, uniformity, resolution accuracy) against industry standards or the manufacturer's specifications, not clinical outcomes or pathology. This document does not detail specific technical performance testing, but rather relies on substantial equivalence.

8. The sample size for the training set

Not Applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not Applicable. See point 8.

Summary

{0}------------------------------------------------

KD62621

510(K) SUMMARY

In accordance with 21 CFR 807.92

1. Date of preparation

September 1, 2006

MAR 1 9 2007

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 5MP-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 5MP .
. 510(k) number: K042221
Manufacturer: Barco NV .

6. Device description

Nio 5MP-21" is a display system for medical viewing. It consists of 3 components:

MDNG-5121 CB is a 21.3" grayscale LCD display. BarcoMed Nio is a fast high-resolution display controller board that plugs into a PACS workstation computer. NioWatch 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 contains multiple displays and display controller boards.

7. Intended use

"The Nio 5MP-21" is intended to be used in displaying digital images, including digital mammography, for review and analysis by trained medical practitioners. The Nio 5MP-21", containing the display MDNG-5121 CB, the software NioWatch and the graphic board

{1}------------------------------------------------

BarcoMed Nio, will be marketed as separate device.

8. Summary of technological characteristics

The device consists of three components:

One 5-megapixel flat panel display (MDNG-5121 CB) .
One 10-bit display controller (BarcoMed Nio board) .
. NioWatch software

The flat panel display has a resolution of 2560x2048 pixels. It can be used in landscape and portrait mode.

The BarcoMed Nio 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 test patterns, calibrate the display and view additional display and display controller information.

Compared to the predicate device, the display of the Nio 5MP-21" system uses the same LCD panel but does not have a built-in front sensor (I-Guard). The accompanying software application has a lower functionality. However, the basic specifications and functions of both systems 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 5MP-21" is substantially equivalent to the predicate device, Coronis 5MP. 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 5MP-21" contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

{2}------------------------------------------------

510(K) SUMMARY

In accordance with 21 CFR 807.92

1. Date of preparation

September 1, 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: MDNG-5121 CB .
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 5421 .
510(k) number: K042221 .
. Manufacturer: Barco NV

6. Device description

MDNG-5121 CB is a 21.3" gravscale LCD display for medical viewing. It is combined with NioWatch, a user-friendly software application that allows to optimize the display for DICOMcompliant viewing.

7. Intended use

"The MDNG-5121 CB is intended to be used in displaying digital images, including digital mammoqraphy, for review and analysis by trained medical practitioners.The MDNG-5121 CB, which is part of the Nio 5MP-21" system, will be marketed separately.

8. Summary of technological characteristics

{3}------------------------------------------------

The flat panel display has a resolution of 2560x2048 pixels. It can be used in landscape or portrait mode.

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

Compared to the predicate device, the MDNG-5121 CB display uses the same LCD panel but does not have a built-in front sensor (I-Guard).

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

9. Conclusion:

The Barco MDNG-5121 CB is substantially equivalent to the predicate device, MFGD 5421. 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 MDNG-5121. CB contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is a stylized image of an eagle or bird-like figure. The image is black and white.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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

MAR 1 9 2007

Re: K062621

Trade/Device Name: Nio 5MP-21 Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 13, 2006 Received: December 18, 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 individe 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 registrations , 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 may publish further and 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/4/Picture/10 description: The image is a black and white circular logo. The logo contains the text "1906-2006" at the top, followed by the letters "FDA" in a bold, blocky font. Below the letters, the word "Centennial" is written in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a thick black border.

Protecting and Promoting Public Health

{5}------------------------------------------------

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.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 vours,

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

{6}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known): K062621

Device Name: Nio 5MP-21"

Indications for Use:

"The Nio 5MP-21″ is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. The Nio 5MP-21", containing the display MDNG-5121 CB, the software NioWatch and the graphic board BarcoMed Nio, will be marketed as separate device.

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

(Division Sion-Off) Division of Reproductive, Abdo 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).