CX50N 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.

Device Description

CX50N 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.

CX50N 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 a 510(k) Summary for the WIDE Corporation CX50N LCD Monitor System. It describes the device, its intended use, and a comparison to a predicate device. However, it does not contain the detailed information needed to fill out all the specific sections of your request regarding acceptance criteria and the study proving the device meets them, particularly concerning AI or diagnostic performance studies.

The document focuses on the monitor's performance as a display device, not on an AI algorithm detecting medical conditions. The "acceptance criteria" discussed are related to display characteristics and compliance with electrical safety and electromagnetic compatibility standards, not diagnostic accuracy.

Here's a breakdown of what can and cannot be answered based on the provided text:

What can be extracted:

1. A table of acceptance criteria and the reported device performance: This is partially available for the monitor's display characteristics, but not for diagnostic performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Based on the text, no such study was performed for an algorithm. The device is a monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a display device. The "ground truth" would relate to the display's ability to accurately represent images, not diagnose.
8. The sample size for the training set: Not applicable as there is no AI algorithm being trained.
9. How the ground truth for the training set was established: Not applicable.

What cannot be extracted from the provided text:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "bench tests" for the monitor's performance but doesn't detail sample sizes or data provenance in the way one would for a diagnostic AI study.
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): Not applicable for a display device clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is a display monitor, not an AI-powered diagnostic tool.

Based on the provided document (K222719) for the CX50N LCD Monitor System:

The device under review is primarily an LCD Monitor System intended for displaying and viewing digital medical images, specifically for mammography and digital breast tomosynthesis applications. It is not an AI diagnostic algorithm. Therefore, many of the questions related to AI algorithm performance studies, expert ground truth establishment, and MRMC studies are not applicable to this device's clearance information.

The "acceptance criteria" and "study" described in the document relate to the physical and functional performance of the medical display monitor itself, ensuring it meets standards for image display quality and safety.

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

The document provides a comparison of technological characteristics between the subject device (CX50N) and its predicate device (K170783). While not explicitly labeled as "acceptance criteria," these are the performance metrics assessed. The "reported device performance" is essentially that the subject device's specifications are either the same or acceptable improvements/differences compared to the predicate.

Attribute	Acceptance Criteria (Predicate / Standard)	Reported Device Performance (Subject CX50N)	Discussion / Compliance
Intended Use	Display digital medical images for review and analysis by trained medical practitioners; specifically for digital mammography and digital breast tomosynthesis.	Same	Complies.
Response Time (typical)	25ms (On/Off)	25ms (On/Off)	Complies.
LCD Panel size	21.3"	21.3"	Complies.
Resolution	2560 x 2048	2560 x 2048	Complies.
Pixel pitch	0.165 mm x 0.165mm	0.165 mm x 0.165mm	Complies.
Maximum luminance	1,200 cd/m²	1,150 cd/m²	Difference noted (lower for subject device), but deemed acceptable and likely within manufacturer's panel specs.
Contrast Ratio	1500 : 1	2000 : 1	Improvement noted (higher for subject device), deemed acceptable.
Input signal	DVI-I, DisplayPort	DVI-I, DisplayPort	Complies.
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz	Complies.
Color/Monochrome	Color	Color	Complies.
QC software	Lumical Advanced	EzCal	Different software, but functions are similar. Deemed acceptable.
Firmware	Version: N1220_221229	Version: N1220_221229	Complies (No change).
Luminance Non-uniformity compensation	Luminance Uniformity Correction	Luminance Uniformity Correction	Complies.
Sensors	Backlight Sensor, IQ Sensor, Ambient Light Sensor	Same	Complies.
USB Ports / Standard	1 upstream, 3 downstream / Rev. 3.0	Same	Complies.
Dimensions (w stand)	390.3 x 520.1 x 248.8 mm	Same	Complies.

Additional Bench Test Items (from Section 8):
The device was tested against instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017. Specific test items include:

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 (Modulation Transfer Function)

The document concludes that the "results of these tests demonstrate that CX50N meets the acceptance criteria and is adequate for this intended use."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "The bench tests below were performed on the CX50N". It does not specify a "sample size" in the context of cases/patients, as this is a hardware device test. It likely refers to testing a specific number of manufactured units or prototypes of the CX50N monitor. Data provenance (country, retrospective/prospective) is not applicable here as it is about hardware testing, not clinical data collection.

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)
Not applicable. The "ground truth" for a monitor is its specified technical performance characteristics and compliance with industry standards (e.g., DICOM Part 14 GSDF). These are measured instrumentally, not by human expert consensus on images.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically used for establishing ground truth in diagnostic studies involving human interpretation, not for validating hardware performance.

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. This device is a display monitor, not an AI diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant for this clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the sense that the monitor's performance was tested independently of human users' diagnostic abilities. However, this is not an "algorithm only" study as no diagnostic algorithm is part of this device cleared in this application. The standalone "performance" refers to the monitor's display characteristics.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance evaluation refers to established technical specifications and compliance with international and FDA-recognized consensus standards for medical displays (e.g., DICOM Part 14 GSDF, IEC 60601-1, IEC 60601-1-2) which are measured by instruments. It is not expert consensus, pathology, or outcomes data related to disease diagnosis.

8. The sample size for the training set
Not applicable. This device is a monitor and does not involve a training set for an AI algorithm.

9. How the ground truth for the training set was established
Not applicable. This device is a monitor and does not involve a training set for an AI algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K222719

May 9, 2023

Trade/Device Name: CX50N Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: September 8, 2022 Received: September 8, 2022

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

{1}------------------------------------------------

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 Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K222719

Device Name CX50N

Indications for Use (Describe)

CX50N 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 specifical mammography applications and digital breast tomosynthesis applications.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary Submission number: K222719

[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)]
  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:	CX50N
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: K170783 WIDE Corporation Applicant:

{4}------------------------------------------------

Model Name:	CX50N(CX50YQS)
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.

CX50N 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)]

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

The table below presents comparisons between the subject device (CX50N) and the predicate device (K170783):

Attributes	Predicate Device	Subject Device	Discussion ofDifferences
Product	CX50N(CX50YQS)	CX50N	-
Intended Use	The CX50N(CX50YQS)LCD Monitor System isintended to be used indisplaying and viewingdigital medical images forreview and analysis bytrained medicalpractitioners. It isspecifically designed fordigital mammographyapplications and digitalbreast tomosynthesisapplications.	CX50N 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	1,150 cd/m²	Provided by the panelmanufacturers.

{5}------------------------------------------------

Contrast Ratio	1500 : 1	2000 : 1	Provided by the panelmanufacturers.
Input signal	DVI-I, DisplayPort	DVI-I, DisplayPort	-
Power Supply	100~240 VAC, 50/60Hz	100~240 VAC, 50/60Hz	-
Color/Monochrome	Color	Color	-
QC software	Lumical Advanced	EzCal	It is only a differencein terms of each QCsoftware, but thefunctions are similar.
Firmware	Version: N1220_221229	Version: N1220_221229	No change of thefirmware.
Luminance Non-uniformity compensation	Luminance UniformityCorrection	Luminance UniformityCorrection	-
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 CX50N device is an updated version of the predicate CX50N (CX50YQS) for the max luminance (from 1,200cd/m2 to 1,150cd/m2) with the improvement of the contrast ratio (from 1,500:1 to 2,000:1). The rest of design features, usability, safety and effectiveness are same.

1. Summary of Non-Clinical Data
  CX50N 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 bench tests below were performed on the CX50N 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
1. Summary of Clinical Data
  No clinical studies were considered necessary and performed.

{6}------------------------------------------------

10. 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 CX50N 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).