The CX20N(CX20PUX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.

Device Description

CX20N(CX20PUX) 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 document describes a 510(k) premarket notification for a medical monitor system, CX20N(CX20PUX). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's standalone performance against a disease or condition. As such, the information you're requesting regarding AI performance, human reader improvement, and clinical study details related to a specific medical condition is not applicable to this device or its submission.

The device is a TFT LCD Medical Monitor System intended for displaying and viewing digital medical images for review and analysis by trained medical practitioners. It is not an AI-powered diagnostic tool.

Below is the information specifically related to the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document refers to technical specifications and compliance with international standards for medical electrical equipment. The "acceptance criteria" are implied by adherence to these standards and by demonstrating comparable performance to a predicate device.

Parameter	Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance (CX20N(CX20PUX))
Technical Characteristics:
Resolution	1600 × 1200 (Matches predicate)	1600 × 1200
Pixel pitch	0.270mm × 0.270mm (Matches predicate)	0.270mm × 0.270mm
Brightness	Comparable to or better than 770cd/m² (Predicate)	800cd/m²
Contrast Ratio	Comparable to or better than 1100:1 (Predicate)	1400:1
LCD Panel Size	21.3" (Matches predicate)	21.3"
Input Signal	DVI-I (Predicate); additional signals acceptable	DVI-I, DisplayPort
Power Supply	100~240 VAC, 50/60Hz (Matches predicate)	100~240 VAC, 50/60Hz
Color/Monochrome	Color (Matches predicate)	Color
Safety Standards (Compliance with):
IEC 60601-1	General Requirements For Basic Safety And Essential Performance	Complies
IEC 60601-1-2	Electromagnetic Compatibility - Requirements And Tests	Complies
Functional Performance (Tests for):	Meets specified criteria	Met Acceptance Criteria
Resolution		Met Acceptance Criteria
Luminance		Met Acceptance Criteria
Contrast		Met Acceptance Criteria
Noise		Met Acceptance Criteria

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

Not applicable. This device is a medical monitor, not a diagnostic or screening algorithm that processes medical image data. The "test set" in this context refers to the physical device itself undergoing engineering and performance verification tests, not a dataset of patient images.

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

Not applicable. As this is a medical display monitor, there is no "ground truth" to be established by medical experts for its performance in diagnosing or detecting conditions. The "ground truth" for this device relates to engineering specifications and performance standards, which are verified through technical measurements performed by qualified testers/engineers.

4. Adjudication Method for the Test Set

Not applicable. The evaluation of the device's adherence to technical specifications and international standards typically involves objective measurements and compliance checks performed by engineers, not a consensus-based adjudication by medical professionals.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC comparative effectiveness study is designed to assess the performance of diagnostic tools (e.g., algorithms or human readers) in interpreting medical images, usually in the context of disease detection or characterization. This device is a display monitor, not a diagnostic tool, so such a study was not performed.

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

Not applicable. This device is a hardware component (monitor) and does not involve an algorithm for diagnostic or interpretative purposes.

7. The Type of Ground Truth Used

For the technical performance aspects, the "ground truth" is defined by the engineering specifications and established international standards (e.g., IEC 60601-1, IEC 60601-1-2) for medical electrical equipment and displays. Compliance is determined by objective measurements against these predefined standards. For the purpose of 510(k) clearance, the primary "ground truth" for the overall device is its substantial equivalence to the predicate device (K032960) in terms of intended use, technological characteristics, and performance.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI algorithms that require a "training set" of data.

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

Not applicable. 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 7, 2016

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

Re: K160355 Trade/Device Name: CX20N(CX20PUX) 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,

Robert Ochs

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) K160355

Device Name CX20N(CX20PUX)

Indications for Use (Describe)

The CX20N(CX20PUX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.

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

[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:	CX20N(CX20PUX)
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:	K032960
Applicant:	WIDE Corporation.
Model Name:	The WIDE 2MP TFT 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)]

CX20N(CX20PUX) is intended to be used to display and view digital medical images for review and analysis by trained medical practitioners.

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	K032960
Model Name	CX20N(CX20PUX)	The WIDE 2MP TFT LCDMonitor System
Manufacturer	WIDE Corporation.
Common Name	TFT LCD Medical Monitor System
Classification Name	Display, Diagnostic Radiology	System, Image Processing,Radiological
Classification Panel	Radiology
Classification Regulation	21 CFR 892.2050
Product Code	PGY	LLZ
Device Class	Class II
Intended Use	CX20N(CX20PUX) is intendedto be used in displaying andviewing digital medical imagesfor review and analysis by trainedmedical practitioners.	The WIDE 2MP TFT LCDMonitor System If 7902Adisplaying and viewing digitalmedical images for review andanalysis by trained medicalpractitioners.
LCD Panel Size	21.3"	21.3"

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

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Parameter	Subject Device	Predicate Device
Resolution	1600×1200	1600×1200
Pixel pitch	0.270mm x 0.270mm	0.270mm x 0.270mm
Brightness	800cd/m²	770cd/m²
Contrast Ratio	1400 : 1	1100:1
Input Signal	DVI-I, DisplayPort	DVI-I
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz
Color/Monochrome	Color	Color

When compared to the predicate devices (K032960), the CX20N(CX20PUX) 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

CX20N(CX20PUX) 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 CX20N(CX20PUX) 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).