MX50N LCD Monitor System is intended to be used in displaying digital medical images for review and analysis by trained medical practitioners. It is specifical mammography applications and digital breast tomosynthesis applications.

Device Description

MX50N LCD Monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.

EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.

MX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical monitor (MX50N), not an AI/ML medical device. Therefore, much of the requested information (such as AI model performance, training/test sets, expert adjudication, MRMC studies, etc.) is not applicable or available in this document.

The document discusses the technical specifications, intended use, and non-clinical testing of the MX50N monitor, comparing it to a predicate device. The "acceptance criteria" here refer to the device meeting specific technical standards and performance metrics for medical display devices, rather than an AI model's diagnostic accuracy.

Given this limitation, I will extract and present the relevant information, while noting when the requested details are not applicable to this type of device and application.

Description of Acceptance Criteria and Study Proving Device Meets Criteria for the MX50N Medical Monitor

The MX50N is a medical display monitor intended for displaying digital medical images, specifically for mammography and digital breast tomosynthesis applications. The acceptance criteria for this device are based on its technical performance and compliance with relevant medical device standards, ensuring it can accurately display medical images for review and analysis by trained practitioners.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for a medical monitor like the MX50N are based on established performance characteristics for display devices in diagnostic radiology. The reported device performance is demonstrated through bench testing against these characteristics.

Acceptance Criteria / Performance Metric	Predicate Device (MX50N(MX50YQS)) Performance	Subject Device (MX50N) Performance	Discussion of Differences / Meeting Criteria
Product Name	MX50N(MX50YQS)	MX50N	-
Intended Use	Displaying and viewing digital medical images for review and analysis by trained medical practitioners; specifically for digital mammography and digital breast tomosynthesis.	Same	Same intended use, indicating substantial equivalence in core function.
Response Time (typical)	25ms (On/Off)	25ms (On/Off)	Meets the same standard.
LCD Panel Size	21.3"	21.3"	Same physical size.
Resolution	2560 x 2048	2560 x 2048	Same high resolution for diagnostic imaging.
Pixel Pitch	0.165 mm x 0.165mm	0.165 mm x 0.165mm	Same pixel density.
Maximum Luminance	1,200 cd/m2	3,000 cd/m2	Improved performance; provided by the panel manufacturers, indicating enhanced brightness which can be beneficial for image display.
Contrast Ratio	1000 : 1	2000 : 1	Improved performance; provided by the panel manufacturers, indicating better distinction between light and dark areas.
Input Signal	DVI-I, DisplayPort	DVI-I, DisplayPort	Same connectivity.
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz	Same power requirements.
Color/Monochrome	Monochrome	Monochrome	Consistent as a monochrome display for medical imaging.
Firmware Version	N1220_221229	N1220_221229	No change, indicating software stability and proven functionality.
QC Software	Lumical Advanced	EzCal	Different software names, but functions are reported to be similar, indicating continued capability for quality control.
Luminance Non-uniformity Compensation	Luminance Uniformity Correction	Luminance Uniformity Correction	Consistent feature ensuring uniform brightness across the display.
Sensors	Backlight Sensor, IQ Sensor, Ambient Light Sensor	Backlight Sensor, IQ Sensor, Ambient Light Sensor	Consistent features for maintaining optimal display conditions.
USB Ports / Standard	1 upstream, 3 downstream / Rev. 3.0	1 upstream, 3 downstream / Rev. 3.0	Same connectivity.
Dimensions (w stand)	390.3 x 520.1 x 248.8 mm	390.3 x 520.1 x 248.8 mm	Same physical dimensions.
Safety and Effectiveness	Demonstrated via standards compliance and comparison to predicate device.	Demonstrated via standards compliance and comparison to predicate device.	Compliance with IEC 60601-1 and IEC 60601-1-2 standards and specific bench tests (Pixel Defects, Artifacts, Luminance, Reflection, Luminance Uniformity, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in horizontal and vertical directions, Temporal Performance Test, Color Tracking, Gray Tracking, MTF).

The key improvements in the subject device (MX50N) over the predicate are in Maximum Luminance and Contrast Ratio, both of which are critical performance aspects for medical displays, especially for mammography.

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

This is not applicable as the device is a medical monitor, not an AI/ML algorithm that processes patient data. The "test set" here refers to the physical monitor itself undergoing bench testing, not a dataset of medical images.

Sample Size for Test Set: Not applicable in the context of data. The "sample" is the physical device unit(s) subjected to testing.
Data Provenance: Not applicable. The testing verifies the physical and electrical performance of the monitor.

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

Not applicable. The "ground truth" for a medical display monitor is its adherence to technical specifications and industry standards for image display. This is verified by objective bench tests and compliance with recognized consensus standards (e.g., DICOM Part 14 GSDF, IEC 60601 series). No human experts are used to establish "ground truth" in this context.

4. Adjudication Method for the Test Set

Not applicable. This is a technical performance verification, not a clinical study involving interpretation or adjudication of diagnostic findings.

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

No, an MRMC comparative effectiveness study was not done. These studies are typically performed for CAD or AI-assisted diagnostic devices to evaluate their impact on human reader performance. For a medical monitor, the effectiveness is demonstrated by its ability to accurately and consistently display images according to established standards.

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

No, this is not applicable. The device is a display monitor, not an algorithm. Its performance is inherently linked to human interaction (a medical practitioner viewing images on it).

7. The Type of Ground Truth Used

The "ground truth" for this device is compliance with:

Technical Specifications: The monitor's ability to meet its stated performance characteristics (e.g., resolution, luminance, contrast, response time).
Industry Standards: Adherence to recognized consensus standards like DICOM Part 14 GSDF for grayscale display function, and IEC 60601 series for medical electrical equipment safety and essential performance.
Predicate Device Equivalence: Demonstrating that its performance is substantially equivalent to, or improved upon, that of a legally marketed predicate device.

This "ground truth" is established through engineering verification and validation (bench testing) against these objective standards.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires ground truth for a training set.

Summary

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WIDE Corporation % Mr. Josh Baker Consultant OT Consulting 33781 Bayside Lane DANA POINT CA 92629

Re: K222716

May 8, 2023

Trade/Device Name: MX50N Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: March 17, 2023 Received: March 20, 2023

Dear Mr. Baker:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality

Enclosure

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Indications for Use

510(k) Number (if known) K222716

Device Name MX50N

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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510(k) Summary Submission number: K222716

[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

Date Prepared [21 CFR 807.92(a) (1)]

06/13/2022

Submitter's Information [21 CFR 807.92(a) (1)]

	Name of Sponsor:	WIDE Corporation.
Address:	15F, The First Tower III, 602, Dongtangiheung-Ro,
	Hwaseong-Si, Gyeonggi-Do 18469, Republic of Korea
Contact Name:	YeoJin Yun
	Telephone #: +82-31-218-1675
	Fax #: +82-31-376-9600
	Email: yyjin@widecorp.com
Registration Number:	3004082357
Name of Manufacturer:	Same as Sponsor
510(k) Contact Person	Josh Baker – Consultant, OT Consulting Inc.
	33781 Bayside Lane, Dana Point, California 92629 USA
	Tel: 714-788-8152
	Email: josh@otconsulting.tech

Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

Model Name:	MX50N
Common Name:	TFT LCD Medical Monitor System
Classification Name:	Medical image management and processing system
Regulation Number:	21 CFR 892.2050
Product Code:	PGY
Device Class:	2
Review Panel:	Radiology

Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

510(k) Number: K170781 WIDE Corporation Applicant: Model Name: MX50N(MX50YQS)

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Common Name:	TFT LCD Medical Monitor System
Classification Name:	Picture archiving and communications system
Regulation Number:	21 CFR 892.2050
Product Code:	PGY
Device Class:	2

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

EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.

MX50N is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.

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

MX50N 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.

Technological Characteristics [21 CFR 807.92(a) (6)]

The table below presents comparisons between the subject device (MX50N) and the predicate device (K170781):

Attributes	Predicate Device	Subject Device	Discussion of Differences
Product	MX50N(MX50YQS)	MX50N	-
Intended Use	The MX50N(MX50YQS) LCDMonitor System isintended to be used indisplaying and viewingdigital medical imagesfor review and analysisby trained medicalpractitioners. It isspecifically designed fordigital mammographyapplications and digitalbreast tomosynthesisapplications.	MX50N LCD MonitorSystem is intended to beused in displaying andviewing digital medicalimages for review andanalysis by trainedmedical practitioners. Itis specifically designedfor digitalmammographyapplications and digitalbreast tomosynthesisapplications.	-
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	0.165 mm x 0.165mm	0.165 mm x 0.165mm	-
Maximum luminance	1,200 cd/m2	3,000 cd/m2	Provided by the panelmanufacturers.

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Contrast Ratio	1000 : 1	2000 : 1	Provided by the panel manufacturers.
Input signal	DVI-I, DisplayPort	DVI-I, DisplayPort	-
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz	-
Color/Monochrome	Monochrome	Monochrome	-
Firmware	Version: N1220_221229	Version: N1220_221229	No change of the firmware.
QC software	Lumical Advanced	EzCal	It is only a difference in terms of each QC software, but the functions are similar.
Luminance Non-uniformity compensation	Luminance Uniformity Correction	Luminance Uniformity Correction	-
Sensors	Backlight Sensor,IQ Sensor,Ambient Light Sensor	Backlight Sensor,IQ Sensor,Ambient Light Sensor	-
USB Ports / Standard	1 upstream,3 downstream / Rev. 3.0	1 upstream,3 downstream / Rev. 3.0	-
Dimensions (w stand)(W x H x D)	390.3 x 520.1 x 248.8 mm	390.3 x 520.1 x 248.8 mm	-

The subject monitor model MX50N device is an improved version of the predicate MX50N (MX50YQS) for the max luminance (from 1,200cd/m2) and the contrast ratio (from 1,000:1 to 2,000:1). The rest of design features, usability, safety and effectiveness are same.

Summary of Non-Clinical Data

MX50N 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 Electrical Equipment - Part 1-2: General IEC 60601-1-2: Medical Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests

The bench tests below were performed on the MX50N following the instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017.

• Test Item

Pixel Defects, Artifacts, Luminance, Reflection, Luminance Uniformity, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in horizontal, and vertical directions, Temporal Performance Test, Color Tracking, Gray Tracking, MTF

Summary of Clinical Data

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No clinical studies were considered necessary and performed.

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 bench tests.

The results of these tests demonstrate that MX50N 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).