The Nio 5MP-M-21″ is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners.
The MDNG-5121 BB is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners.

Device Description

Nio 5MP-M-21" is a display system for medical viewing. It consists of 3 components: MDNG-5121 BB 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.
The device consists of three components: One 5-megapixel flat panel display (MDNG-5121 BB). 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 a 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.

AI/ML Overview

The provided 510(k) summary for the Barco Nio 5MP-M-21" (K062131) does not include a study that proves the device meets specific acceptance criteria in the way a clinical performance study would for an AI/algorithm-based device.

This submission is for a medical display system, not an AI or diagnostic algorithm. The acceptance criteria and "study" described below are based on the information provided in the 510(k) where the manufacturer asserts substantial equivalence to a predicate device by comparing technical characteristics.

Here's the information structured to address your request, with clarifications where the information is not applicable or not present in a display system 510(k):

Acceptance Criteria and Device Performance (for a display system)

Acceptance Criteria (Functionality/Characteristics)	Reported Device Performance (Nio 5MP-M-21")
Intended Use: Displaying digital images, including digital mammography, for review and analysis by trained medical practitioners.	Intended Use: "The Nio 5MP-M-21" is intended to be used in displaying digital images, including digital mammography, for review and analysis by trained medical practitioners." (Same as predicate)
Display Type: Flat panel display for medical viewing.	Display Type: MDNG-5121 BB is a 21.3" grayscale LCD display.
Resolution: Suitable for medical imaging, including mammography (predicate has 5MP).	Resolution: 2560x2048 pixels (5-megapixel). (Matches predicate)
Grayscale shades: High bit depth for medical imaging (predicate has 10-bit LUT).	Grayscale shades: 10-bit lookup table, providing 256 simultaneous shades of gray (from an 8-bit input). (Matches predicate)
Components: Display, controller board, QA software.	Components: MDNG-5121 BB (display), BarcoMed Nio (controller board), NioWatch (softcopy QA software). (Similar to predicate, with noted differences in I-Guard and software functionality but basic specs and functions are same).
Safety: Device does not come into contact with the patient; does not control life-sustaining devices.	Safety: Device does not come into contact with the patient. It does not control any life sustaining devices either. (Same as predicate)
Equivalence to Predicate: Substantially equivalent in technical characteristics, general function, application, and intended use; no effect on safety or efficacy due to differences.	Conclusion: "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."

Study Information (as applicable to a medical display 510(k) for substantial equivalence):

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This 510(k) is for a medical display system, not an AI/diagnostic algorithm that relies on a test set of patient data for performance evaluation. The "test" involves comparing the technical specifications and intended use of the new device against a legally marketed predicate device.
- Data Provenance: Not applicable in the context of patient data. The provenance pertains to the technical specifications and operational performance metrics of the device itself and its predicate.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" derived from expert consensus on medical images in the context of this 510(k). The evaluation is based on engineering specifications and regulatory comparison.
Adjudication method for the test set:
- Not applicable. No test set requiring adjudication of diagnostic outcomes was used.
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 not an AI-assisted diagnostic device. The submission is for a display system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a display system, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" equivalent in this type of submission is the established technical specifications and regulatory compliance of the predicate device, against which the new device's characteristics are compared for substantial equivalence.
The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that would require a training set.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary of the "Study" (Substantial Equivalence Justification):

The "study" presented in this 510(k) is a comparison of technical characteristics between the proposed device (Nio 5MP-M-21") and its predicate device (Coronis 5MP). The manufacturer asserts that the devices are substantially equivalent, meaning the new device is as safe and effective as the predicate.

Methodology: The manufacturer lists the technical components and specifications of the Nio 5MP-M-21" and directly compares them to those of the Coronis 5MP.
Key Finding: The report states: "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."
Differences noted: The primary difference is the absence of a built-in front sensor (I-Guard) in the Nio 5MP-M-21" display and lower functionality in its accompanying software application compared to the predicate. However, the basic specifications and functions relevant to displaying medical images are deemed the same.

In essence, the "study" is a technical comparison intended to demonstrate that the new device does not raise new questions of safety or effectiveness compared to a device already cleared for market. This is the standard approach for a medical display system 510(k) rather than a clinical performance study involving patient data.

Summary

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K062131

510(K) SUMMARY

In accordance with 21 CFR 807.92

1. Date of preparation

July, 22 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: Nio 5MP-M-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-M-21" is a display system for medical viewing. It consists of 3 components:

MDNG-5121 BB 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-M-21″ is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners.

NOV 17 2006

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8. Summary of technological characteristics

The device consists of three components:

One 5-megapixel flat panel display (MDNG-5121 BB) .
. 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 a 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 5MP-M-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-M-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-M-21" 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 Blvd. Rockville MD 20850

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

NOV 17 2006

Re: K062131 Trade/Device Name: MDNG-5121 BB Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 9, 2006 Received: October 11, 2006

Dear Mr. De Wendel:

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.

Image /page/2/Picture/7 description: The image is a black and white circular logo. The logo contains the letters "PA" in a bold, stylized font. Above the letters, the numbers "1906-2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font. Three stars are placed below the word "Centennial".

Protecting and Promoting Public Health

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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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrl/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

Page 2 -

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INDICATIONS FOR USE

510(k) Number (if known): K062131

Device Name: MDNG-5121 BB

Indications for Use:

"The MDNG-5121 BB is intended to be used in displaying digital images, including digital mammography, for review and analasys by trained medical practitioners.

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 C. Broadon
Division Sign-Off

Division Sign-C Division of Reproduce and Radiological Dev 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).