The CX50N(CX50YQS) 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 and digital breast tomosynthesis applications.

Device Description

CX50N(CX50YQS) 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 color image display. The WIDE controller board is installed into the PACS workstation computer system to display PACS medical images.

AI/ML Overview

The provided text describes the WIDE Corporation CX50N(CX50YQS) LCD Monitor System, which displays medical images for review and analysis, specifically for digital mammography and digital breast tomosynthesis. The document is a 510(k) summary indicating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (Predicate Device K160326)	Reported Device Performance (CX50N(CX50YQS))
Intended Use	Displaying and viewing medical images for diagnosis in digital mammography PACS, FFDM, and breast tomosynthesis.	Displaying and viewing digital medical images for review and analysis by trained medical practitioners, specifically designed for digital mammography and digital breast tomosynthesis.
Response Time	25ms (On/Off)	25ms (On/Off)
LCD Panel Size	21.3"	21.3"
Resolution	2560 x 2048	2560 x 2048
Pixel Pitch	0.165mm x 0.165mm	0.165mm x 0.165mm
Brightness	1000cd/m²	800cd/m²
Contrast Ratio	1300 : 1	800 : 1
Input Signal	DVI-I, DisplayPort	DVI-I, DisplayPort
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz
Color/Monochrome	Color	Color
Safety	Compliance with IEC 60601-1 and IEC 60601-1-2 (Electromagnetic Compatibility) standards.	Compliance achieved with IEC 60601-1 and IEC 60601-1-2.
Effectiveness	Meeting acceptance criteria for resolution, luminance, contrast, and noise as specified in standards.	Tests conducted for resolution, luminance, contrast, and noise met the acceptance criteria specified in the standards.

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

The document does not specify a "test set" in the context of medical images or patient data. The testing described focuses on the monitor's technical specifications and compliance with international standards for electrical safety and electromagnetic compatibility. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) related to imaging data. The device itself (the monitor) underwent non-clinical testing.

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

Since this is a medical display device, not an AI-powered diagnostic tool, the concept of "ground truth" derived from expert interpretation of medical images does not apply in the context of the described testing. The 'ground truth' for the acceptance criteria would be the established technical standards and performance specifications for medical displays.

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

Not applicable, as there was no test set involving human interpretation of medical images.

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 device is a medical monitor, not an AI-assisted diagnostic tool. No MRMC comparative effectiveness study was reported.

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

Not applicable. This device is an LCD monitor; it does not perform algorithmic analysis or have a standalone diagnostic function. Its performance is evaluated based on its ability to accurately display images.

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

For the safety and effectiveness testing of the monitor, the "ground truth" was established by international and FDA-recognized consensus standards (IEC 60601-1, IEC 60601-1-2) which define the technical performance requirements for medical electrical equipment and displays. The tests for resolution, luminance, contrast, and noise are objective measurements against these predefined technical specifications.

8. The sample size for the training set:

Not applicable. This device is a hardware monitor, not a machine learning algorithm that requires a training set.

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

Not applicable, as there was no training set.

Summary

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

March 31, 2017

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

Re: K170783

Trade/Device Name: CX50N(CX50YOS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 10, 2017 Received: March 15, 2017

Dear YeoJin 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. O'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) K170783

Device Name CX50N(CX50YQS)

Indications for Use (Describe)

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

2 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)]

03/10/2017

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:	CX50N(CX50YQS)
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: K160326
Applicant: JVC KENWOOD Corporation
Model Name: 5MP Color LCD Monitor CCL550i2 (CL21550
Common Name: TFT LCD Medical Monitor System
Classification Name: Display, Diagnostic Radiology
Regulation Number: 21 CFR 892.2050
Product Code: PGY
Device Class: 2

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

Subject of this new 510(k) premarket notification is an addition to the indications for use for the CX50N(CX50YQS). The device was cleared via premarket notification K160351. There is no any change of configuration/components and functionality of the subject device as compared with cleared device (K160351).

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	K160326
Model Name	CX50N(CX50YQS)	5MP Color LCD MonitorCCL550i2 (CL21550)
Manufacturer	WIDE Corporation.	JVC KENWOOD Corporation
Common Name	TFT LCD Medical Monitor System
Classification Name	Display, Diagnostic Radiology
Classification Panel	Radiology
Classification Regulation	21 CFR 892.2050
Product Code	PGY
Device Class	Class II
Intended Use	The CX50N(CX50YQS) LCDMonitor System is intended to beused in displaying and viewing	5MP Color LCD MonitorCCL550i2 (CL21550) areintended to be used in displaying

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

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Parameter	Subject Device	Predicate Device
	digital medical images for reviewand analysis by trained medicalpractitioners. It is specificallydesigned for digital mammographyapplications and digital breasttomosynthesis applications.	and viewing medical images fordiagnosis by trained medicalpractitioners.They are to be used in digitalmammography PACS,modalities including FFDM, andbreast tomosynthensis Type oftomosynthensis.
Response Time(Typical)	25ms (On/Off)	25ms (On/Off)
LCD Panel Size	21.3"	21.3"
Resolution	2560 x 2048	2560 x 2048
Pixel pitch	0.165mm x 0.165mm	0.165mm x 0.165mm
Brightness	800cd/m²	1000cd/m²
Contrast Ratio	800 : 1	1300 : 1
Input Signal	DVI-I, DisplayPort	DVI-I, DisplayPort
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz
Color/Monochrome	Color	Color

When compared to the predicate devices (K160326), the CX50N(CX50YQS) presented in this submission has the same of the followings:

Intended Use
Technological characteristics
Response Time
LCD Panel Size
Resolution
Pixel pitch

The two devices share the similar performance as the following:

· Brightness
Contrast Ratio

There is no significant difference between the CX50N(CX50YQS) and the predicate device that would adversely affect the use of the product. The subject device is substantially equivalent to the predicate device in intended use, technological characteristics, panel size, resolution, pixel pitch, brightness and contrast ratio.

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9. Summary of Non-Clinical Data

CX50N(CX50YQS) comply with the following international and FDA-recognized consensus standards:

IEC 60601-1:		Medical Electrical Equipment --- Part 1: General
		Requirements For Basic Safety And Essential Performance
IEC 60601-1-2:		Medical Electrical Equipment - Part 1-2: General
		Requirements 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.

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 CX50N(CX50YQS) meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical 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).