The Nio 3MP LED (MDNG-3220) Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.

Device Description

The Nio 3MP LED (MDNG-3220) is a high-resolution flat panel LCD display system for reviewing medical images. It consists of an LCD display (MDNG-3220), an optional high-resolution display controller board and QA software. The display controller board is installed in a PACS workstation computer, connected to the display. The QA software helps to make and keep the displays DICOM compliant. The display uses LED backlight technology.

AI/ML Overview

Here's an analysis of the provided text regarding the Barco Nio 3MP LED (MDNG-3220) medical display system. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical trials for new technologies.

Important Note: The provided document describes a medical flat panel display system, not an AI or algorithm-based device. Therefore, many of the requested points related to AI/algorithm performance (e.g., sample sizes for test/training sets, ground truth establishment, MRMC studies, standalone performance) are not applicable to this type of device. The acceptance criteria and "study" described are for hardware performance validation and comparison to a predicate display, not for diagnostic accuracy of an AI.

1. Table of Acceptance Criteria and Reported Device Performance

Modification to Device	Test Performed	Acceptance Criteria	Reported Device Performance
LED backlight instead of CCFL	Optical tests, DICOM calibration, Luminance Uniformity tests	Pass the test	Passed (device has similar or superior characteristics)
Different platform (including firmware)	Functional tests	Pass the test	Passed (device has similar or superior characteristics)
Additional DisplayPort video input	Functional tests	Pass the test	Passed (device has similar or superior characteristics)
Front sensor implementation	Front sensor qualification test	Maximum 5% deviation	Passed (device has similar or superior characteristics)
Other material of front filter	Impact test	There shall be no cracking of the enclosure. There shall be no live parts that become accessible.	Passed (device has similar or superior characteristics)
Other material for sheet metal parts	Vibration and drop tests	Pass the test	Passed (device has similar or superior characteristics)
Not explicitly tied to specific modification	EMC test (IEC 60601-1-2)	Compliance with IEC 60601-1-2 standard	Passed (device has similar or superior characteristics)

Summary of Device Performance: The document states that "The tests showed that the device has similar or superior characteristics compared to the predicate device and did not reveal new issues of safety and performance."

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable as the device is a medical display, not an AI algorithm processing diagnostic data. The "tests" refer to bench tests and functional performance evaluations of the hardware itself (e.g., optical properties, structural integrity), not evaluation against a dataset of medical images.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable. Ground truth, in the context of AI, refers to the definitive correct diagnosis or finding in a medical image dataset. For a display device, the "ground truth" is the specified engineering performance metric (e.g., luminance, uniformity), which is measured by test equipment, not human experts.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication refers to methods used to resolve discrepancies in expert interpretations of medical images for ground truth establishment. This concept does not apply to the bench testing of a display monitor.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools that assist human readers. The Nio 3MP LED is a display monitor, not an AI tool.

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

This is not applicable. The device is a display monitor, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for a display device's performance is typically established through engineering specifications and measurements using calibrated testing equipment. For example, luminance is measured with a photometer, and DICOM conformance is checked against the standard. It is not expert consensus, pathology, or outcomes data, as those relate to diagnostic content interpreted on the device, not the device's intrinsic performance.

8. The Sample Size for the Training Set

This is not applicable. The device is a hardware display, not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable. There is no training set for a display monitor.

In summary: The provided document is a 510(k) submission for a medical display device (monitor). The "acceptance criteria" and "study" refer to engineering-level bench tests and functional evaluations to demonstrate that the new device (Nio 3MP LED) is substantially equivalent to a previously cleared predicate device (Nio 3MP) in terms of safety and effectiveness, despite some technological changes (primarily the backlight technology, additional video input, and sensory components). The questions related to AI/algorithm performance, ground truth, and human reader studies are not relevant to this specific device or its regulatory submission.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 10, 2015

Barco N.V. Healthcare Division % Lieven De Wandel 35 President Kennedypark Kortriik B-8500 Belgium

Re: K150821

Trade/Device Name: Nio 3MP LED (MDNG-3220) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 12, 2015 Received: March 27, 2015

Dear Lieven 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K150821

Device Name Nio 3MP LED (MDNG-3220)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary (in accordance with 21 CFR 807.92)
1. Company	Barco N.V.Healthcare Division35 President KennedyparkB-8500 KortrijkBELGIUM
2. Contactperson	Lieven De WandelRegulatory Affairs Officer
3. Date ofsubmission	March 12, 2015
4. Deviceinformation	Trade name/model:Common name:Classification name:Classification code:Regulation number:	Nio 3MP LED (MDNG-3220)Nio 3MP LCD displaySystem, image processing, RadiologicalPGY892.2050
5. Predicatedevice	Nio 3MP (E-3620 MA) cleared under 510(K) K040041
6. Devicedescription	The Nio 3MP LED (MDNG-3220) is a high-resolution flat panel LCD display system forreviewing medical images. It consists of an LCD display (MDNG-3220), an optional high-resolution display controller board and QA software.The display controller board is installed in a PACS workstation computer, connected to thedisplay. The QA software helps to make and keep the displays DICOM compliant.The display uses LED backlight technology.
7. Intended Useof the Device	The Nio 3MP LED (MDNG-3220) Medical Flat Panel Display System is intended to beused as a tool in displaying and viewing digital images (excluding digital mammography)for review and analysis by trained medical practitioners.
8. Comparisonof technologicalcharacteristics	Product acronym		MDNG-3220	E-3620 MA
	Screen technology		TFT AM LCD Dual DomainIPS	TFT AM LCD Dual DomainIPS
	Active screen size (diagonal)		520 mm (20.8")	528 mm (20.8")
	Active screen size (H x V)		424 mm x 318 mm(16.69" x 12.52")	424 x 318 mm (16.7 x12.5")
	Aspect ratio (H:V)		4:3	4:3
	Resolution		3MP (2048 x 1536)	3MP (2048 x 1536)
	Pixel pitch		0.207 mm	0.207 mm
	Color imaging		No	No
	Gray imaging		Yes	Yes

	Viewing angle (H, V)		176°	170°
	Uniform Luminance Technology (ULT)		Yes	Yes
	Per Pixel Uniformity (PPU)		No	No
	Ambient Light Compensation (ALC)		No	No
	Backlight Output Stabilization (BLOS)		Yes	Yes
	I-Guard		Yes	No
	Maximum luminance		1200 cd/m²	1000 cd/m²
	DICOM calibrated luminance (ULT off)		500 cd/m²	500 cd/m²
	Contrast ratio (typical)		1200:1	900:1
	Response time (Tr + Tf)		30 ms	50 ms
	Scanning frequency (H; V)		15-129 kHz; 25-98 Hz	30-124 kHz; 50-85 Hz
	Video input signals		DVI-D Dual Link /DisplayPort	DVI-D Dual Link
	USB ports		1 upstream, 2downstream	1 upstream, 2downstream
	USB standard		2.0	1.1
	Power requirements (nominal)		100-240V	100-240V
	Power consumption (nominal)		50W	54W
	Power save mode		Yes	Yes
	Net weight with stand		13 kg	13 kg
	Net weight w/o stand		8 kg	9 kg
9. Performancetesting	The bench tests mentioned below were performed to validate the device characteristicsthat differ from the predicate device:
	Modification to device		Test performed	Criteria
	LED backlight instead ofCCFL		Optical tests, DICOMcalibration and LuminanceUniformity tests	Pass the test
	Different platform (includingfirmware)		Functional tests	Pass the test
	Additional DisplayPortvideo input		Functional tests	Pass the test
	Front sensorimplementation		Front sensor qualificationtest	Maximum 5% deviation
	Other material of front filter		Impact test	There shall be no crackingof the enclosure.There shall be no live partsthat become accessible.
	Other material for sheetmetal parts		Vibration and drop tests	Pass the test

BARCO

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BARCO

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	Additional tests performed: EMC test (IEC 60601-1-2)
	The tests showed that the device has similar or superior characteristics compared to thepredicate device and did not reveal new issues of safety and performance.
	Animal or clinical testing have not been performed.
10. Conclusion	The Nio 3MP LED (MDNG-3220) was found to be substantially equivalent to the predicatedevice, due to the following reasons:
	a) Device and predicate device have the same intended useb) The technological characteristics differences from the predicate device do notaffect safety or effectivenessc) Bench testing showed that the device has similar or superior characteristicscompared to the predicate device and did not reveal new issues of safety andperformance.

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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).