The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.

Device Description

CX30N(CX30PQX) 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 510(k) summary for the CX30N(CX30PQX) LCD Monitor System, which is a medical image display device. It is important to note that this document is for a medical monitor, not an AI/ML algorithm. Therefore, many of the typical acceptance criteria and study aspects related to AI/ML device performance (like MRMC studies, ground truth establishment for training/test sets, or expert consensus for labeling) are not applicable here.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the technical performance specifications of the monitor and the tests conducted to demonstrate that the monitor meets these specifications and relevant safety standards for its intended use as a medical display.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a medical display like the CX30N(CX30PQX) are typically based on industry standards and performance specifications for medical imaging. The document highlights a comparison with a predicate device, which implicitly defines common performance expectations.

Parameter	Acceptance Criteria (Implied / Predicate Performance)	Reported Device Performance (CX30N(CX30PQX))
Intended Use	Display and view digital medical images for review and analysis by trained medical practitioners. (Not for mammography)	Display and view digital medical images for review and analysis by trained medical practitioners. (Not for mammography)
LCD Panel Size	21.3"	21.3"
Resolution	2048 x 1536	2048 x 1536
Pixel Pitch	0.21mm x 0.21mm	0.2109mm x 0.2109mm
Brightness	1000 cd/m² (Predicate)	900 cd/m²
Contrast Ratio	1500:1 (Predicate)	1400:1
Input Signal	DVI-D, DisplayPort (Predicate)	DVI-I, DisplayPort
Safety	Compliance with IEC 60601-1	Complies with IEC 60601-1
EMC	Compliance with IEC 60601-1-2	Complies with IEC 60601-1-2
Effectiveness	Meeting standards for resolution, luminance, contrast, and noise.	Tests met acceptance criteria

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

For a medical monitor, the "test set" does not refer to clinical image data in the same way it would for an AI/ML algorithm. Instead, the testing involves the device itself.

Sample Size: The document implies that testing was conducted on the CX30N(CX30PQX) device as a unit. It doesn't specify a "sample size" in terms of multiple devices, typically performance testing like resolution, luminance, contrast, and noise are done on prototypes or production samples to ensure they meet specifications.
Data Provenance: Not applicable in the context of clinical image data. The "data" here are the performance measurements of the monitor itself. The manufacturer is WIDE Corporation, located in the Republic of Korea. The testing would have been conducted by the manufacturer or accredited testing labs.

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

Not applicable. For a medical monitor, "ground truth" is established through physical measurement standards and calibration, not expert interpretation of images. The performance of the display is objectively measured against technical specifications and international standards (e.g., luminance, resolution). Human experts are the users of the display, not the ones establishing its ground truth.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to the review of image data (e.g., for disease diagnosis) where there might be inter-reader variability. For a display device, performance measurements like brightness or resolution are objectively quantifiable and don't require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is a clinical study design used to evaluate the diagnostic performance of a medical imaging system or a CAD (Computer-Aided Detection)/AI device by assessing how human readers' diagnostic accuracy changes with and without the assistance of the device, across multiple cases. This is not applicable to a digital medical display itself, which is a display hardware, not a diagnostic aid.

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

Not applicable. The CX30N(CX30PQX) is a display device, not an algorithm. Its "performance" is its ability to accurately display images according to specifications, not to interpret or diagnose.

7. The Type of Ground Truth Used

The ground truth for this device (a medical monitor) is based on:

Technical Specifications: Defined parameters like resolution (e.g., 2048x1536 pixels), pixel pitch, brightness (cd/m²), contrast ratio, and input signal compatibility.
International Standards: Compliance with recognized safety and performance standards such as IEC 60601-1 (general safety) and IEC 60601-1-2 (electromagnetic compatibility).
Measured Performance: Calibration and testing results (e.g., resolution, luminance, contrast, noise) demonstrating that the device meets these specifications and standards.

8. The Sample Size for the Training Set

Not applicable. This device is a hardware display and does not involve AI/ML algorithms that require a "training set" of data.

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

Not applicable. As explained above, there is no AI/ML training set for this device.

In summary, for the CX30N(CX30PQX) LCD Monitor System:

The acceptance criteria are primarily technical specifications and compliance with international safety and performance standards for medical displays. The study proving these criteria are met involves non-clinical bench testing to measure parameters like resolution, luminance, contrast, and noise, and to verify compliance with electrical safety and electromagnetic compatibility standards (IEC 60601-1 and IEC 60601-1-2). The document explicitly states that "No clinical studies were considered necessary and performed," which is typical for a device like a monitor where performance is assessed through engineering and physical measurements rather than clinical diagnostic accuracy studies.

Summary

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

April 14, 2016

WIDE Corporation % Mr. YeoJin Yun RA Manager 12 Wongomae-ro, Giheung-gu Yongin-si, Gyeonggi-do 17086 REPUBLIC OF KOREA

Re: K160348

Trade/Device Name: CX30N(CX30POX) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: February 5, 2016 Received: March 14, 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) K160348

Device Name CX30N(CX30PQX)

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:	CX30N(CX30PQX)
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:	K153354
Applicant:	EIZO CORPORATION
Model Name:	3MP Color LCD Monitor, RadiForce RX350
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)]

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

CX30N(CX30PQX) is intended to be used to display and view digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.

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	K153354
Model Name	CX30N(CX30PQX)	3MP Color LCD Monitor.RadiForce RX350
Manufacturer	WIDE Corporation.	EIZO 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	CX30N(CX30PQX) is intendedto be used in displaying andviewing digital medical imagesfor review and analysis by trainedmedical practitioners. The displayis not intended formammography.	This product is intended to beused in displaying and viewingdigital images for review,analysis and diagnosis by trainedmedical practitioners. It does notsupport the display ofmammography images fordiagnosis.
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	2048×1536	2048×1536
Pixel pitch	0.2109mm x 0.2109mm	0.21mm x 0.21mm
Brightness	900cd/m²	1000cd/m²
Contrast Ratio	1400 : 1	1500:1
Input Signal	DVI-I, DisplayPort	DVI-D, DisplayPort
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz
Color/Monochrome	Color	Color

When compared to the predicate devices (K155354), the CX30N(CX30PQX) 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:

Contrast Ratio
· Brightness
Input Signal

9. Summary of Non-Clinical Data

CX30N(CX30PQX) 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 CX30N(CX30PQX) 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).