The MX50N(MX50YQS) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.

Device Description

MX50N(MX50YQS) is a flat panel hi-resolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system to display PACS medical images.

AI/ML Overview

The document provided is a 510(k) premarket notification for a medical LCD monitor system (MX50N(MX50YQS)). This type of submission is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through extensive clinical trials. Therefore, the information typically found in studies proving a device meets acceptance criteria for an AI/algorithm-based diagnostic device will not be present.

Based on the provided document, here's an analysis of the acceptance criteria and supporting study information:

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (from predicate/standards)	Reported Device Performance (MX50N(MX50YQS))
Non-Clinical Performance Data (compared to predicate K052312)
LCD Panel Size	21.3" (Predicate)	21.3"
Resolution	2560 × 2048 (Predicate)	2560 × 2048
Pixel pitch	0.165mm x 0.165mm (Predicate)	0.165mm x 0.165mm
Brightness	1000cd/m² (Predicate)	1200cd/m²
Contrast Ratio	700 : 1 (Predicate)	1000 : 1
Input Signal	DVI-I (Predicate)	DVI-I, DisplayPort
Power Supply	100~240 VAC, 50/60Hz (Predicate)	100~240 VAC, 50/60Hz
Color/Monochrome	Monochrome (Predicate)	Monochrome
Compliance to Standards
IEC 60601-1	General Requirements For Basic Safety And Essential Performance	Complies
IEC 60601-1-2	Electromagnetic Compatibility - Requirements And Tests	Complies
Specific Performance Tests
Resolution	Acceptance criteria specified in standards	Met acceptance criteria
Luminance	Acceptance criteria specified in standards	Met acceptance criteria
Contrast	Acceptance criteria specified in standards	Met acceptance criteria
Noise	Acceptance criteria specified in standards	Met acceptance criteria

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. This submission is for a medical monitor, not an AI/algorithm-based diagnostic device that processes image data for diagnosis directly. The "tests" mentioned are technical performance verifications of the display hardware (resolution, luminance, contrast, noise) against engineering specifications and international standards, not a diagnostic accuracy study on a dataset of patient cases.
Data Provenance: Not applicable. The tests are technical assessments of the device itself.

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

Not applicable. Ground truth in the context of diagnostic interpretation by experts is not relevant for technical performance testing of a monitor. The "ground truth" here is the specified technical performance metrics and compliance with industry standards.

4. Adjudication Method for the Test Set

Not applicable. There is no diagnostic interpretation or consensus needed for the technical performance tests of a monitor.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The device (a medical monitor) is not an AI algorithm that improves human reader performance. It is a display device for medical images. The submission focuses on its technical specifications and compliance with safety standards.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The MX50N(MX50YQS) is a display device, not an algorithm. Its "standalone performance" refers to its technical specifications (brightness, resolution, contrast, etc.) and compliance with electrical and safety standards.

7. Type of Ground Truth Used

For the technical performance tests (resolution, luminance, contrast, noise), the "ground truth" or reference is established by specified acceptance criteria in international and consensus standards (e.g., IEC 60601-1, IEC 60601-1-2 and likely other display performance standards such as DICOM Part 14, though not explicitly listed as a test item in the summary).

8. Sample Size for the Training Set

Not applicable. The MX50N(MX50YQS) is a hardware device (LCD monitor system) and not an AI or machine learning algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

Summary

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

April 22, 2016

WIDE Corporation % Mr. YeoJin Yun RA Manager 12 Wongomae-Ro, Giheung-Gu Yongin-Si, Gyeonggi-Do 17086 REPUBLIC OF KOREA

Re: K160353

Trade/Device Name: MX50N(MX50YOS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: February 5, 2016 Received: February 8, 2016

Dear Mr. Yun:

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/Resourcesfor You/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.

Michael D.'Hara

For

Robert Ochs, Ph.D. 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) K160353

Device Name MX50N(MX50YQS)

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)

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FOR FDA USE ONLY

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

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510(k) Summary

[As required by 21 CFR 807.92]

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92

1. Date Prepared [21 CFR 807.92(a) (1)]

02/05//2016

2. Submitter's Information [21 CFR 807.92(a) (1)]

Name of Sponsor:	WIDE Corporation.
Address:	12 Wongomae-Ro, Giheung-Gu, Yongin-Si, Gyeonggi-Do17086, Republic of Korea
Contact Name:	YeoJin Yun
	Telephone #: +82-31-218-1675
	Fax #: +82-31-218-7400
	Email: yyjin@widecorp.com
Registration Number:	3004082357
Name of Manufacturer:	Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

Model Name:	MX50N(MX50YQS)
Common Name:	TFT LCD Medical Monitor System
Classification Name:	Display, Diagnostic Radiology
Regulation Number:	21 CFR 892.2050
Product Code:	PGY
Device Class:	2
Review Panel:	Radiology

4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

510(k) Number:	K052312
Applicant:	WIDE Corporation.
Model Name:	WIDE 5MP (MAMMO) LCD MONITOR SYSTEM
Common Name:	TFT LCD Medical Monitor System
Classification Name:	System, Image Processing, Radiological
Regulation Number:	21 CFR 892.2050
Product Code:	LLZ
Device Class:	2

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5. Description of the Device [21 CFR 807.92(a) (4)]

6. Intended Use [21 CFR 807.92(a) (5)]

7. Technological Characteristics [21 CFR 807.92(a) (6)]

The device is an image display system which consists of computer software and components. The device does not contact the patient, nor does it control any life sustaining devices. A physician or trained medical practitioner provides ample opportunity for competent human intervention to interpret images and information being displayed.

Parameter	Subject Device	Predicate Device
510(k) Number	Unknown	K052312
Model Name	MX50N(MX50YQS)	WIDE 5MP (MAMMO) LCDMONITOR SYSTEM
Manufacturer	WIDE Corporation.
Common Name	TFT LCD Medical Monitor System
Classification Name	System, Image Processing, Radiological	Picture archiving andcommunications system
Classification Panel	Radiology
Classification Regulation	21 CFR 892.2050
Product Code	PGY	LLZ
Device Class	Class II
Intended Use	The MX50N(MX50YQS) LCDMonitor System is intended to beused in displaying and viewingdigital medical images for reviewand analysis by trained medicalpractitioners. It is specificallydesigned for digitalmammography applications.	The 5MP (Mammo) LCDMonitor System" is intended tobe used in displaying andviewing medical digital imagesfor review and analysis bytrained medical practitioners. Itis specifically designed fordigital mammographyapplications.

8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]

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Parameter	Subject Device	Predicate Device
LCD Panel Size	21.3"	21.3"
Resolution	2560 ×2048	2560 x 2048
Pixel pitch	0.165mm x 0.165mm	0.165mm x 0.165mm
Brightness	1200cd/m²	1000cd/m²
Contrast Ratio	1000 : 1	700 : 1
Input Signal	DVI-I, DisplayPort	DVI-I
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz
Color/Monochrome	Monochrome	Monochrome

When compared to the predicate devices (K052312), the MX50N(MX50YQS) presented in this submission has the same of the followings:

Intended Use
Technological characteristics
LCD Panel Size
Resolution
Pixel pitch

The two devices share the similar performance as the following:

· Brightness
Contrast Ratio

9. Summary of Non-Clinical Data

MX50N(MX50YQS) comply with the following international and FDA-recognized consensus standards:

IEC 60601-1:	Medical Electrical Equipment -- Part 1: GeneralRequirements For Basic Safety And Essential Performance
IEC 60601-1-2:	Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance -Collateral Standard: Electromagnetic Compatibility -Requirements And Tests

The tests conducted for resolution, luminance, contrast and noise all met the acceptance criteria specified in the standards.

10. Summary of Clinical Data

No clinical studies were considered necessary and performed.

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11. Conclusion [21 CFR 807.92(b) (3)]

Subject Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, the safety of the subject device was validated through tests including IEC60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through tests for resolution, luminance, contrast and noise.

The results of these tests demonstrate that MX50N(MX50YQS) meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, nonclinical performance data, safety testing demonstrates that the device is as safe and effective as the predicate device and performs as well as the predicate device.

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).