The MDNC 3120 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 MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately.

The Nio Color 3MP 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 Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device.

Device Description

MDNC 3120 is a 20.8" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

Nio Color 3MP is a display system for medical viewing. It consists of 3 components: MDNC 3120 is a 20.8" color LCD display. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control. The system also contains a fast high-resolution display controller board that plugs into a PACS workstation computer. Standard the system is delivered with the MXRT 2100 board, but the user can opt for another type of display controller board (MXRT 5100 or MXRT 7100). 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 document describes two similar devices, MDNC 3120 and Nio Color 3MP. Both are medical display systems. The provided text is a 510(k) summary, which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of filing does not typically include detailed studies proving performance against acceptance criteria in the way a new, novel device might. Instead, the focus is on a comparison to existing devices.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for this device is largely absent because it's not a requirement for a 510(k) substantial equivalence submission for a display system. The "study" here is essentially the comparison to a predicate device.

Here's a breakdown of what can be extracted or inferred from the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the 510(k) summary in terms of a formal “acceptance criteria” and “reported device performance” table for the new device. The acceptance criteria for a 510(k) for a display device are typically centered around demonstrating substantial equivalence to a predicate device, meaning it performs as safely and effectively.

The "performance" is implicitly deemed equivalent to the predicate device E-2320C (for MDNC 3120) and Color Nio 2MP (for Nio Color 3MP) because the manufacturer states: "The basic specifications and functions, however, are the same." and "Any difference between both devices does not affect safety or efficacy."

Key Specifications mentioned for the new devices:

Resolution: 2048 x 1536 pixels
Display type: 20.8" color LCD (MDNC 3120)
Software: MediCal QAWeb Agent (optimizes for DICOM-compliant viewing, sets display function, test patterns, calibrates, views controller info).
Display Controller (for Nio Color 3MP system): 3-megapixel flat panel display, 32-bit display controller, up to 64-bit color.

Comparison to Predicate:
The document states that the new devices have "a different LCD panel, other electronic and mechanical parts" and (for Nio Color 3MP) "The software is a new version." However, it asserts that "The basic specifications and functions of all the parts are the same" and "Any difference between both devices does not affect safety or efficacy." This forms the basis of their claim of substantial equivalence.

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

Sample size: Not applicable. This is not a study involving patient data or images in the traditional sense for assessing diagnostic performance. The "test" for a display device in a 510(k) is usually a technical comparison to a predicate device, focusing on specifications and functionality.
Data provenance: Not applicable. No clinical or image data is mentioned.

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

Number of experts: Not applicable. Ground truth, in the context of diagnostic performance, is not established for this type of device submission. The device is a display, not an AI algorithm performing diagnosis.
Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Adjudication method: Not applicable.

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

MRMC study: No. This is a display device, not an AI-powered diagnostic tool. Such a study would not be applicable.

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

Standalone study: No. This is not an algorithm.

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

Type of ground truth: Not applicable.

8. The sample size for the training set

Sample size: Not applicable. This device does not use a "training set" in the machine learning sense.

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

Ground truth establishment: Not applicable.

In summary:

The provided document is a 510(k) premarket notification for medical display systems. The "study" for this type of device, as presented here, is a demonstration of substantial equivalence to existing predicate devices based on a comparison of technical specifications, intended use, and general functionality. It does not involve clinical performance studies with patient data, diagnostic accuracies, or expert-adjudicated ground truth, as those are typical for diagnostic imaging algorithms or novel clinical devices, not medical display systems. The acceptance criteria are implicitly met by demonstrating that the new devices' characteristics are "substantially equivalent" to the predicate devices and that any differences do not affect safety or efficacy.

Summary

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510(K) SUMMARY

In accordance with 21 CFR 807.92

1. Date of preparation

March, 8 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: MDNC 3120
. 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: E-2320C
. 510(k) number: K052958
. Manufacturer: Barco NV

6. Device description

MDNC 3120 is a 20.8" color LCD display for medical viewing. It is combined with MediCal QAWeb Agent, a user-friendly software that allows to optimize the display for DICOM-compliant viewing.

7. Intended use

"The MDNC 3120 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 MDNC 3120, which is part of the Nio Color 3MP system, will be marketed separately.

8. Summary of technological characteristics

K070726

MAY - 2 2007

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The flat panel display has a resolution of 2048 x 1536 pixels. It can be used in landscape or portrait mode.

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

Compared to the predicate device, the MDNC 3120 display has a different LCD panel, other electronic and mechanical parts. The basic specifications and functions, however, 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 MDNC 3120 is substantially equivalent to the predicate device, E-2320C. 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 MDNC 3120 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

March, 8 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 Color 3MP
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: Color Nio 2MP
. 510(k) number: K052958
. Manufacturer: Barco NV

6. Device description

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

MDNC 3120 is a 20.8" color LCD display. MediCal QAWeb Agent is a softcopy QA software application for local calibration and QA control. The system also contains a fast high-resolution display controller board that plugs into a PACS workstation computer. Standard the system is delivered with the MXRT 2100 board, but the user can opt for another type of display controller board (MXRT 5100 or MXRT 7100)

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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 Color 3MP is intended to be used in displaying and viewing digital images for review by

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trained medical practitioners. These devices must not be used in primary image diagnosis in mammography. The Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, will be marketed as separate device.

8. Summary of technological characteristics

The device consists of three components:

One 3-megapixel flat panel display (MDNC 3120) .
. One 32-bit display controller
MediCal QAWeb Agent software .

The flat panel display has a resolution of 2048 x 1536 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 lookup table, providing up to 64 bit color.

The MediCal QAWeb Aqent software allows to set the display test patterns. calibrate the display and view additional display controller information.

Compared to the predicate device, the display from the Nio Color 3MP system has a different LCD panel, other electronic boards and other mechanical parts. The software is a new version. However, the basic specifications and functions of all the parts 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 Color 3MP is substantially equivalent to the predicate device, Color Nio 2MP.

i, i.

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 Color 3MP 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/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a sans-serif font. The text is black and is on a white background. The text is centered in the image.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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

MAY - 2 2007

K070726 Re:

Trade/Device Name: Nio Color 3MP and MDNC 3120 Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 8, 2007 Received: March 15, 2007

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.

Image /page/4/Picture/9 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars at the bottom of the logo, and the entire design is surrounded by a dotted border.

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.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. 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

510(k) Number (if known): K010226

Device Name: Nio Color 3MP

Indications for Use:

"The Nio Color 3MP 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 tramou mounty. The Nio Color 3MP, containing the display MDNC 3120, the software MediCal QAWeb Agent and a graphic board, 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _

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INDICATIONS FOR USE

510(k) Number (if known): K076226

Device Name: MDNC 3120

Indications for Use:

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 Chrogdon

Dinsion Sian-Off ann of Reproductive, Abdo Anlogical Devices neiki 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).