The MX30N(MX30TQS) 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

MX30N(MX30TQS) 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 describes the K160346 submission for the MX30N(MX30TQS) medical monitor system. This device is a medical display and not an AI/algorithm system. Therefore, the provided information does not include details on a study proving a device meets acceptance criteria related to AI or complex algorithm performance (e.g., diagnostic accuracy, reader improvement with AI assistance).

The acceptance criteria and "study" described are for the technical performance of a medical display, ensuring it meets standards comparable to a predicate device.

Here's an analysis based on the provided text, focusing on the monitor's performance rather than AI:

1. A table of acceptance criteria and the reported device performance

The document provides a comparison table of the subject device (MX30N(MX30TQS)) with a predicate device (WIDE 3MP TFT LCD MONITOR). The "acceptance criteria" are implied by meeting or exceeding the performance of the predicate device and complying with specific international standards for medical electrical equipment.

Parameter	Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (MX30N(MX30TQS))
Intended Use	Same as predicate: Display and view digital medical images for review and analysis by trained medical practitioners (not for mammography).	Same as predicate.
Technological Characteristics	Same as predicate (flat panel hi-resolution LCD monitor, graphic control board for PACS workstation).	Same as predicate.
LCD Panel Size	≥ 21.3"	21.3"
Resolution	≥ 2048 x 1536	2048 x 1536
Pixel Pitch	≤ 0.21mm x 0.21mm	0.21075mm x 0.21075mm
Brightness	≥ 800 cd/m²	1700 cd/m²
Contrast Ratio	≥ 600:1	1400:1
Input Signal	DVI-D	DVI-I, DisplayPort
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz
Color/Monochrome	Monochrome	Monochrome
Electrical Safety	Compliance with IEC 60601-1	Complied
EMC	Compliance with IEC 60601-1-2	Complied
Resolution Test	Met acceptance criteria specified in standards	Met acceptance criteria
Luminance Test	Met acceptance criteria specified in standards	Met acceptance criteria
Noise Test	Met acceptance criteria specified in standards	Met acceptance criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable in the context of an "AI/algorithm" test set because the device is a medical monitor. The "test set" for this device would refer to the physical unit(s) of the MX30N(MX30TQS) monitor used for engineering and performance validation testing.

Sample Size: Not specified, but typically one or a few production units are thoroughly tested for conformity to standards.
Data Provenance: Not applicable in the sense of patient data. The tests are performed on the device itself against technical specifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The "ground truth" for a medical display's performance relates to its physical and electronic characteristics (e.g., brightness, resolution, compliance with electrical safety standards), not diagnostic interpretations. These are measured by calibrated equipment and verified against engineering specifications and international standards, not by clinical experts establishing a ground truth for medical images.

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

This is not applicable. Adjudication methods like '2+1' or '3+1' are used for consolidating expert opinions on controversial cases in diagnostic image interpretation. This is not relevant for testing a display's technical specifications.

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

This is not applicable. MRMC studies evaluate the diagnostic performance of human readers, sometimes with and without AI assistance, on a set of medical cases. The MX30N(MX30TQS) is a display monitor, not an AI algorithm, and therefore such a study was not performed or necessary for its clearance.

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

This is not applicable. This question refers to the performance of an AI algorithm on its own. The MX30N(MX30TQS) is a hardware display device, not an algorithm.

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

The "ground truth" for this device's performance is based on engineering specifications and international consensus standards (e.g., IEC 60601-1, IEC 60601-1-2) for medical electrical equipment and displays. Performance parameters like resolution, luminance, contrast, and noise are objectively measured by testing equipment and compared against these predefined numerical standards. No clinical ground truth (like pathology or outcomes) is involved in certifying a display.

8. The sample size for the training set

This is not applicable. Display monitors are hardware devices and do not have "training sets" in the context of machine learning or AI.

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

This is not applicable for the same reason as point 8.

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: K160346

Trade/Device Name: MX30N(MX30TOS) 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) K160346

Device Name MX30N(MX30TQS)

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:	MX30N(MX30TQS)
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: K032174
Applicant: WIDE Corporation.
Model Name: WIDE 3MP TFT LCD MONITOR
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)]

MX30N(MX30TQS) 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	K032174
Model Name	MX30N(MX30TQS)	WIDE 3MP TFT LCDMONITOR
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	MX30N(MX30TQS) is intendedto be used in displaying andviewing digital medical images forreview and analysis by trainedmedical practitioners. The displayis not intended for mammography.	The WIDE 3MP TFT LCDmonitor intended to be used indisplaying and viewing digitalmedical images for review andanalysis by trainedmedical practitioners
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	$2048\times1536$	$2048\times1536$
Pixel pitch	0.21075mm x 0.21075mm	0.21mm x 0.21mm
Brightness	1700cd/m²	800 cd/m²
Contrast Ratio	1400 : 1	600:1
Input Signal	DVI-I, DisplayPort	DVI-D
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz
Color/Monochrome	Monochrome	Monochrome

When compared to the predicate devices (K032174), the MX30N(MX30TQS) 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
Input Signal

9. Summary of Non-Clinical Data

MX30N(MX30TQS) 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 MX30N(MX30TQS) 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).