The MX50TQS) 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 breast tomosynthesis applications.

Device Description

MX50T(MX50TQS) 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 provided text describes the WIDE Corporation's MX50T(MX50TQS) LCD monitor system, which is intended for displaying and viewing digital medical images for review and analysis by trained medical practitioners, specifically for digital mammography and breast tomosynthesis applications.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Parameter	Acceptance Criteria (from Predicate Device)	Reported Device Performance (MX50T(MX50TQS))
LCD Panel Size	21.3"	21.3"
Resolution	2560 × 2048	2560 × 2048
Pixel pitch	0.165mm x 0.165mm	0.165mm x 0.165mm
Brightness	2,100cd/m²	2000cd/m²
Contrast Ratio	950:1	1000:1
Input Signal	DVI-I	DVI-I, DisplayPort
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz
Color/Monochrome	Monochrome	Monochrome

Note: The document states that the MX50T(MX50TQS) has "similar performance" for Brightness and Contrast Ratio compared to the predicate device, although the numerical values are slightly different. The acceptance criteria for these would likely be defined by a range that encompasses these values and demonstrates sufficient image quality for the intended use. The other listed parameters are either identical or the subject device offers an additional compatible input signal (DisplayPort), which expands functionality without compromising the predicate's capabilities.

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

Sample Size: Not explicitly stated. The document mentions "tests conducted for resolution, luminance, contrast and noise" without specifying the number of units or images tested.
Data Provenance: Not explicitly stated. The non-clinical tests were conducted to comply with international and FDA-recognized consensus standards (IEC 60601-1 and IEC 60601-1-2). Given the manufacturer's location (Republic of Korea), it's likely the testing was performed there or by a recognized testing facility. The data provenance is non-clinical, related to electrical safety and performance characteristics of the monitor itself, not patient data.

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

Not applicable as no clinical studies were performed. The "ground truth" for this device relates to its technical specifications and adherence to safety and performance standards for a medical display.

4. Adjudication method for the test set:

Not applicable as no clinical studies were performed requiring expert adjudication of patient data. The "adjudication" for this type of device would involve verifying that the physical measurements and tests meet the specified technical criteria in the standards.

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 MRMC or comparative effectiveness study involving human readers or AI was performed. The device is a medical display, not an AI-powered diagnostic tool.

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

Not applicable. The device is a medical monitor, not an algorithm. Its performance is evaluated based on its physical characteristics and adherence to technical standards for displaying medical images.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests consisted of the established requirements and specifications outlined in the international and FDA-recognized consensus standards (IEC 60601-1, IEC 60601-1-2, and likely other display performance standards implicitly referenced by the tests for resolution, luminance, contrast, and noise). This is a technical, rather than a clinical, ground truth.

8. The sample size for the training set:

Not applicable. This device is an LCD monitor, not an AI/machine learning algorithm requiring a training set.

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

Not applicable. As noted above, this device does not utilize a training set.

Summary of the Study Proving Acceptance Criteria are Met:

The study proving the device meets its acceptance criteria is a non-clinical performance and safety testing study.

Study Design: The manufacturer conducted tests to evaluate the device's technical specifications and adherence to relevant safety and performance standards.
Tests Performed:
- Safety Tests: Compliance with IEC 60601-1 (General Requirements For Basic Safety And Essential Performance) and IEC 60601-1-2 (Electromagnetic Compatibility).
- Performance Tests: Evaluation of resolution, luminance, contrast, and noise.
Results and Conclusion: "The tests conducted for resolution, luminance, contrast and noise all met the acceptance criteria specified in the standards." and "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 overall conclusion is that the MX50T(MX50TQS) "meets the acceptance criteria and is adequate for this intended use."

In essence, the "study" for this medical display is a series of engineering and electrical tests demonstrating that the monitor physically performs as expected according to its technical specifications and meets the regulatory safety and electromagnetic compatibility requirements for medical electrical equipment. No clinical data or human-in-the-loop studies were deemed necessary due to the nature of the device (a display monitor).

Summary

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

May 19th, 2016

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

Re: K160354 Trade/Device Name: MX50T(MX50TQS) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: February 5, 2016 Received: April 7, 2016

Dear Mr. Yun:

This letter corrects our substantially equivalent letter of May 2, 20016.

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

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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. 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,

Jeff Rodriquez

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) K160354

Device Name MX50T(MX50TQS)

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)

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:	MX50T(MX50TQS)
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:	K103792
Applicant:	BARCO NV.
Model Name:	BARCO MAMMO TOMOSYNTHESIS
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	K103792
Model Name	MX50T(MX50TQS)	BARCO MAMMOTOMOSYNTHESIS
Manufacturer	WIDE Corporation.	BARCO NV.
Common Name	TFT LCD Medical Monitor System
Classification Name	Display, Diagnostic Radiology	System, Image ProcessingRadiological
Classification Panel	Radiology
Classification Regulation	21 CFR 892.2050
Product Code	PGY	LLZ
Device Class	Class II
Intended Use	The MX50T(MX50TQS) LCDMonitor System is intended to beused in displaying and viewingdigital medical images for reviewand analysis by trained medicalpractitioners. It is specificallydesigned for digitalmammography applications andbreasttomosynthesis	The Barco MammoTomosynthesis (MIDMVG-5221)device is intended to be used indisplaying and viewing digitalimages, including standard andmulti-frame digitalmammography, for review,analysis, and diagnosis by trainedmedical practitioners. It is

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

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Parameter	Subject Device	Predicate Device
	applications.	specially designed for breasttomosynthesis applications.
LCD Panel Size	21.3"	21.3"
Resolution	2560 × 2048	2560 × 2048
Pixel pitch	0.165mm x 0. 165mm	0.165mm x 0. 165mm
Brightness	2000cd/m²	2,100cd/m²
Contrast Ratio	1000 : 1	950:1
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 (K103792), the MX50T(MX50TQS) 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

MX50T(MX50TQS) 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.

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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 MX50T(MX50TQS) 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).