JUSHA-C61 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.

Device Description

JUSHA-C61 LCD Monitor is the display system with the high resolution (3280*2048), high luminance ( 700cd/m² ), 10 bit display colors expanded to 12 bit color expansion technology, 7 DICOM look up table and one GAMMA2.2 look up table inside. In particular, JUSHA-C61 LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. JUSHA-C61 LCD Monitor has ambient brightness adapting and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.

The product is consisted of the following components:

30.0 inch, a-Si TFT Liquid Crystal Display
JUSHA-C61 motherboard/FR-4/REV:2.0
JUSHA-C61 LCD Monitor software
Power Adapter
Data Cable.

The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005+CORR.1(2006)+CORR.2(2007)
IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1- 2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests.

AI/ML Overview

The provided document describes a medical display monitor (JUSHA-C61 LCD Monitor) and its substantial equivalence to a predicate device (EIZO RX650) based on non-clinical testing. It does not perform or describe a study related to acceptance criteria for an AI/algorithm's performance.

The document is a 510(k) premarket notification for a hardware device (LCD monitor), not an AI algorithm. Therefore, many of the requested categories (expert ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this submission.

Here's an analysis based on the information available:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of an algorithm's performance. Instead, it demonstrates substantial equivalence to a predicate device based on technical specifications and adherence to voluntary and mandatory standards. The "performance" here refers to the technical specifications of the monitor itself.

Attribute	Predicate Device (EIZO RX650)	Proposed Device (JUSHA-C61 LCD Monitor)
Screen technology	30.0" Color TFT LCD Panel	30.0" Color TFT LCD Panel
Viewing angle (H, V)	Horizontal 176°, Vertical 176°	Horizontal 170°, Vertical 170°
Resolution	2048 x 3280 / 3280 x 2048	2048 x 3280 / 3280 x 2048
Display area	645.5(H) x 403.0 (V) mm	645.5 (H) x 403.0 (V) mm
Contrast Ratio	1000:1	1000:1
Recommended Luminance	400cd/m²	400cd/m²
Pixel Pitch	0.197x0.197 mm	0.197x0.197 mm
Backlight	LED	LED
Display Colors	10-bit, 1.07 billion colors	12-bit, 68.7 billion colors (This is actually better, not just equivalent)
Luminance calibration	Built in calibration sensor provided	Built in calibration sensor provided
Input signals	DVI standard 1.0, DisplayPort 1.1a	DVI standard 1.0, DisplayPort 1.1a
Input terminational	DVI-D Dual Link x2, DisplayPort x2	DVI-D Dual Link x2, DisplayPort x2
Display controller	Off the shelf	Off the shelf
Power Requirement	AC 100~~240V 50~~60Hz	AC 100~~240V 50~~60Hz
Power Consumption/Save Mode	108W / less than 6W	100W / less than 1.5W (Improved power efficiency)
Power Management	DVI DMPM	DVI DMPM, DisplayPort 1.1a
USB Ports/standard	1 upstream (endpoint), 2 downstream / Rev. 2.0	1 upstream (endpoint), 2 downstream / Rev. 2.0
Applicable standard	IEC 60601-1, IEC 60601-1-2 Ed 3	IEC 60601-1, IEC 60601-1-2 Ed 3

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 as the submission is for a hardware device (monitor), not an AI algorithm evaluated on a test set of medical images. The "testing" referred to in the document pertains to hardware compliance with electrical and safety standards (e.g., IEC 60601-1, IEC 60601-1-2).

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. No ground truth for medical images was established or used for the evaluation of this display monitor.

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

This is not applicable for the reasons stated above.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human performance, which is not the subject of this 510(k) submission.

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

This is not applicable. There is no "algorithm only" product being evaluated in this submission; it's a display monitor.

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

This is not applicable. The device is a display monitor, not a diagnostic algorithm.

8. The sample size for the training set

This is not applicable. The device is a display monitor and does not involve AI training.

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

This is not applicable.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and has a simple, clean design. The caduceus symbol is a common symbol for healthcare and medicine.

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

August 1, 2014

Nanjing Jusha Display Technology Co., Ltd. % Ms. Li Le Certification Manager 8A, Block 1, Nanjing International Service Outsourcing Mansion, No. 301 Hanzhongmen Street, Nanjing 210036 CHINA

Re: K141679

Trade/Device Name: Jusha-C61 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 24, 2014 Received: June 30, 2014

Dear Ms. Le:

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 (OS) 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,

FDA

for Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K141679

Device Name

JUSHA-C61 LCD Monitor

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)

Smh.7)

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."

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510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date:	May 6, 2014
Submitter:	Nanjing Jusha Display Technology Co., LtdAdd: 301, 8F Block A, No.1, Nanjing International ServiceOutsourcing Mansion, Hanzhongmen Street, Nanjing, 210036 China
Contact Person:	Li leCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783271
Device Trade Name:	JUSHA-C61 LCD Monitor
Common/Usual Name:	6MP Color LCD Monitor
Classification Name: Product Code:	Display, Diagnostic Radiology 21CFR 892.2050PGY
Predicate Device(s):	EIZO RX650;K134002
Device Description:	JUSHA-C61 LCD Monitor is the display system with the highresolution (3280*2048), high luminance ( $700cd/m^2$ ), 10 bit displaycolors expanded to 12 bit color expansion technology, 7 DICOM lookup table and one GAMMA2.2 look up table inside. In particular,JUSHA-C61 LCD Monitor contains CGA function, it is speciallymade by JUSHA, it can automatic identify gray and color signals,then gray area calls DICOM LUT and color area calls GAMMA2.2LUT. JUSHA-C61 LCD Monitor has ambient brightness adapting andpresence induction system, with these this display can automaticadjustment according to different requirements in order to achieve thebest results.
	The product is consisted of the following components:
	- 30.0 inch, a-Si TFT Liquid Crystal Display
	- JUSHA-C61 motherboard/FR-4/REV:2.0
	- JUSHA-C61 LCD Monitor software
	- Power Adapter
	- Data Cable.
	The LCD Monitor is designed, tested, and will be manufactured inaccordance with both mandatory and voluntary standards:
	IEC 60601-1Medical equipment medical electrical equipment - Part 1:General requirements for basic safety and essential performance2005+CORR.1(2006)+CORR.2(2007)
	IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -
	Collateral standard: Electromagnetic compatibility - Requirementsand tests.
Intended Use:	JUSHA-C61 LCD Monitor is intended to be used in displaying andviewing digital images for review and analysis by trained medicalpractitioners. It does not support the display of mammography imagesfor diagnosis.
Technology:	JUSHA-C61 LCD Monitor is the display system with the highresolution (3280*2048) with electronic capabilities for evaluation ofhigh resolution medical images, high luminance (700cd/m²), 10 bitdisplay colors expanded to 12 bit color expansion technology, 7DICOM look up table and one GAMMA2.2 look up table inside. Inparticular, JUSHA-C61 LCD Monitor contains CGA function, it isspecially made by JUSHA, it can automatic identify gray and colorsignals, then gray area calls DICOM LUT and color area callsGAMMA2.2 LUT. JUSHA-C61 LCD Monitor has ambient brightnessadapting and presence induction system, with these this display canautomatic adjustment according to different requirements in order toachieve the best results.
Determination of SubstantialEquivalence:	Summary of Non-Clinical Tests:The LCD Monitor complies with voluntary standards as following:IEC 60601-1Medical equipment medical electrical equipment - Part 1:General requirements for basic safety and essential performance2005+CORR.1(2006)+CORR.2(2007)IEC 60601-1-2 Edition 3:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirementsand tests.JUSHA-C61 is substantially equivalent to EIZO RX650. JUSHA-C61 employs the maximum resolution values same as that of EIZORX650. Comparison table of the principal characteristics of 2 devicesis shown in the Attachment 1.The following quality assurance measures were applied to thedevelopment of the system:Risk AnalysisRequirements ReviewsDesign ReviewsRaw materials verificationTesting on unit level (Module verification)Integration testing (System verification)Final acceptance testing (Validation)Performance testing (Verification)Safety testing (Verification)
	Summary of Clinical Tests:The subject of this premarket submission, LCD Monitor, did notrequire clinical studies to support substantial equivalence.
	The proposed device is Substantially Equivalent (SE) to the predicatedevice which is US legally market device. Therefore, the subjectdevice is determined as safe and effectiveness.
Conclusion:	Nanjing Jusha Display Technology Co., Ltd Considers the JUSHA-C61 LCD Monitor to be as safe, as effective, and performance issubstantially equivalent to the predicate device(s).

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510(k) Premarket Notification Submission

Attachment 1:

Attributes	Predicate Device	Proposed Device
Product	EIZO RX650	JUSHA-C61 LCD Monitor
510(k) Number	K134002	K141679
Screen technology	30.0" Color TFT LCD Panel	30.0" Color TFT LCD Panel
Viewing angle (H, V)	Horizontal 176°, Vertical 176°	Horizontal 170°, Vertical 170°
Resolution	2048 x 3280/3280x 2048	2048 x 3280/3280x 2048
Display area	645.5(H) x 403.0 (V) mm	645.5 (H) x 403.0 (V) mm
Contrast Ratio	1000:1	1000:1
RecommendedLuminance	400cd/m²	400cd/m²
Pixel Pitch	0.197x0.197 mm	0.197x0.197 mm
Backlight	LED	LED
Display Colors	10-bit ,1.07 billion colors	12-bit, 68.7billion colors
Luminancecalibration	Built in calibration sensor provided	Built in calibration sensor provided
Input signals	DVI standard 1.0,DisplayPort 1.1a	DVI standard 1.0,DisplayPort 1.1a
Input terminational	DVI-D Dual Link x2Display Port x2	DVI-D Dual Link x2Display Port x2
Display controller	Off the shelf	Off the shelf
Power Requirement	AC 100~~240V 50~~60Hz	AC 100~~240V 50~~60Hz

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	510(k) Premarket Notification Submission

PowerConsumption/SaveMode	108W/less than 6W	100W/less than 1.5W
Power Management	DVI DMPM	DVI DMPMDisplayPort 1.1a
USB Ports/standard	1 upstream (endpoint), 2downstream/ Rev. 2.0	1 upstream (endpoint), 2downstream/ Rev. 2.0
Dimensions w/o stand(W x H x D)	Without stand:692mmx466mmx109 mm Withstand:692mmx478~643mmx302 mm	Without stand:704mm x 478mm x 81mmWith stand:704mm x 611mm x292mm
Applicable standard	1 IEC 60601-1Medical equipmentmedical electrical equipment - Part 1:General requirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007)2 IEC 60601-1-2 Edition 3:2007,Medical electrical equipment - Part1-2: General requirements for basicsafety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements andtests.	1 IEC 60601-1Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007)2 IEC 60601-1-2 Edition3:2007, Medical electricalequipment - Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic compatibility -Requirements and tests.

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).