JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

Device Description

JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor is the display system with the high resolution (1600*1200), high luminance (800 cd/m²), and 14-bit grayscale (16384 level), built-in DICOM standard LUT. In particular, JUSHA-M260G has real-time DICOM automatic calibration 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:

21.3" Mono-TFT LCD Panel
DMX0302CR0/main board/V1.2
JUSHA-M260G LCD Monitor software
Power Adapter
Data Cable.

AI/ML Overview

The provided text describes a 510(k) submission for the JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor. This device is a diagnostic display, not an AI/ML algorithm. Therefore, the questions related to AI/ML specific acceptance criteria, such as "effect size of human readers improve with AI vs without AI assistance," "standalone performance," "ground truth establishment for training set," and "adjudication method for the test set" are not applicable.

The acceptance criteria for this type of device are based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical bench testing for display performance, electrical safety, and electromagnetic compatibility.

Here's a breakdown based on the provided information:

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

Since this is a display monitor, the "acceptance criteria" are generally that the proposed device performs at least as well as, or is substantially equivalent to, the predicate device in key display parameters and safety. Performance is demonstrated through bench testing against established industry standards.

Acceptance Criteria (Bench Test Demonstrations)	Reported Device Performance / Compliance
Display Performance:
Angular dependency of luminance response	Meets performance standards
Luminance non-uniformity characteristics	Meets performance standards (TG18 guideline)
Chromaticity non-uniformity characteristics	Meets performance standards (TG18 guideline)
Small-spot contrast ratio	Meets performance standards
Temporal response	Meets performance standards
Luminance stability	Meets performance standards
Electrical Safety:	Complies with IEC 60601-1
Electromagnetic Compatibility (EMC):	Complies with IEC 60601-1-2
DICOM Standard LUT:	14-bit: 16384 (Predicate was 12-bit: 4096, demonstrating improvement)
Resolution:	1600 x 1200 / 1200 x 1600 (Same as predicate)
Contrast Ratio:	1400:1 (Same as predicate)
Screen Technology:	21.3" Mono-TFT LCD Panel (Same as predicate)
Viewing Angle:	Horizontal 178°, Vertical 178° (Predicate was 176°, slightly improved)

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

Sample Size for Test Set: Not applicable in the context of an AI/ML test set. For a monitor, performance is tested on the device itself against specifications and standards. This is typically done on a single or small number of manufactured units to demonstrate general compliance.
Data Provenance: Not applicable. The "data" here refers to the physical performance characteristics of the monitor, not a dataset of patient images.

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

Not applicable. This device is a monitor, not an AI/ML algorithm that generates diagnostic outputs requiring expert ground truth for interpretation. Its performance is measured objectively against technical specifications and established standards (e.g., TG18 guideline).

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

Not applicable. Adjudication methods are used to establish a consensus ground truth in studies involving human interpretation or AI outputs, which is not relevant for a display monitor's performance evaluation.

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. No MRMC study was conducted or required, as stated in the document ("The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence.").

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

Not applicable. This device is a display monitor, not an algorithm.

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

Not applicable. The "ground truth" for a display monitor is its adherence to universally accepted technical standards for image display (e.g., DICOM, luminance, resolution, contrast). These are measurable objective properties, not clinical "truths."

8. The sample size for the training set

Not applicable. This is a hardware device (LCD monitor), not a machine learning model. There is no concept of a "training set" for its development.

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

Not applicable, as there is no training set for this type of device.

Summary

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K183497

Device Name

JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor

Indications for Use (Describe)

JUSHA-M260G/JUSHA-M260/M260 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.

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

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

Date:	December 6, 2018
Submitter:	Nanjing Jusha Display Technology Co., LtdAdd: 301, 8F Block A, No.1, Nanjing International ServiceOutsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 China
Contact Person:	Zilong LiangCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783273
Device Trade Name:	JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor
Common/Usual Name:	2MP monochrome LCD Monitor
Classification Name:	Display, Diagnostic Radiology 21CFR 892.2050
Product Code:	PGY
Predicate Device(s):	JUSHA-M23C; K151238
Device Description:	JUSHA-M260G/JUSHA-M260/M260G/M260 LCD Monitor is thedisplay system with the high resolution (1600*1200), high luminance(800 cd/m²), and 14-bit grayscale (16384 level), built-in DICOMstandard LUT. In particular, JUSHA-M260G has real-time DICOMautomatic calibration 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:- 21.3" Mono-TFT LCD Panel- DMX0302CR0/main board/V1.2- JUSHA-M260G LCD Monitor software- Power Adapter- Data Cable.
	accordance with both mandatory and voluntary standards:
	1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2 NO.60601-1:14, Medical equipmentmedical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance.2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015,CFR 47 FCC Part15 subpart B: 2017, Medical electricalequipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral standard:Electromagnetic disturbances - Requirements and tests.
Intended Use:	JUSHA-M260G LCD Monitor is intended to be used in displayingand viewing digital images for diagnosis of X-ray or MRI, etc. bytrained medical practitioners. The device does not support the displayof mammography images for diagnosis.
Technology:	JUSHA-M260G LCD Monitor is the display system with the highresolution (1600*1200), high luminance (800 cd/m2), and 14-bitgrayscale (16384 level), built-in DICOM standard LUT. In particular,JUSHA-M260G has real-time DICOM automatic calibration system,with these this display can automatic adjustment according todifferent requirements in order to achieve the best results
Determination of SubstantialEquivalence:	Summary of Non-Clinical Tests:The LCD Monitor complies with voluntary standards as following:
	1 IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2NO.60601-1:14, Medical equipment medical electrical equipment- Part 1: General requirements for basic safety and essentialperformance.2 IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47FCC Part15 subpart B: 2017, Medical electrical equipment - Part1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagnetic disturbances -Requirements and tests.
	JUSHA-M260G is substantially equivalent to JUSHA-M23C.JUSHA-M260G employs the maximum resolution values same as thatof JUSHA-M23C. Comparison table of the principal characteristics of2 devices is shown in the Attachment 1.
	Attachment 1The following quality assurance measures were applied to the
	development of the system:
	• Risk Analysis
	• Requirements Reviews
	• Design Reviews
	• Raw materials verification
	• Testing 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 not require clinical studies to support substantial equivalence.
	The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness.
Conclusion:	Nanjing Jusha Display Technology Co., Ltd Considers the JUSHA-M260G LCD Monitor to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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This comparison identifies the similarities and differences of the proposed JUSHA-M260G LCD Monitor device to the legally marketed predicate JUSHA-M23C LCD Monitor device to which substantial equivalency is claimed.

Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-M23C	JUSHA-M260G
510(k) Number	K151238	/
Display Performance/Specifications
Screentechnology	21.3" Mono-TFT LCD Panel	21.3" Mono-TFT LCD Panel	Same
Viewing angle(H, V)	Horizontal 176°,Vertical176°	Horizontal 178°, Vertical178°	-
Resolution	1600 x 1200/1200 x 1600	1600 x 1200/1200 x 1600	Same
Display area	432.0 (H) x 324.0(V) mm	432.0 (H) x 324.0(V) mm	Same
Contrast Ratio	1400:1	1400:1	Same
Scanningfrequency (H; V)	52~~76 kHz;59~~61Hz	37.9~75kHz;60Hz	This differencebetween the twodevice is causedby the differentno display areadefined bydifferentmanufacturers ,nothing to dowith the displayfunction
RecommendedLuminance	500cd/m²	400cd/m²	This differencebetween the twodevice is causedby the differentno display areadefined bydifferentmanufacturers ,nothing to dowith the displayfunction
Pixel Pitch	0.27x0.27 mm	0.27x0.27 mm	Same
Backlight	LED	LED	Same
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-M23C	JUSHA-M260G
510(k) Number	K151238	/
DICOM LUT	12-bit:4096	14-bit:16384	TheJUSHA-M260GLCD Monitoruses a color bitexpansiontechnology toimprove imagedisplay quality,the image clarityis better than theimage displayedon the predicatedevice.
Luminance calibration	Built in calibration sensorprovided	Built in calibration sensorprovided	Same
		Video Signal Input
Input signals	DVI-D x 1,	DVI-D x 1,	Same
	DisplayPort x 1	DisplayPort x 1
Displaycontroller	Off the shelf	Off the shelf	Same
		Power Related Specification
PowerRequirement	AC 100~~240V 50~~60Hz	DC 12V	-
PowerConsumption/Save Mode	45W/less than 3W	50W/less than 0.5W	The differencescaused bycomponents usedin the LCDMonitor. Thisonly shows thepowerconsumption isdifferent,nothing to dowith the displayfunction
Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-M23C	JUSHA-M260G
510(k) Number	K151238	/
PowerManagement	DVI DMPMDisplayPort 1.1a	DVI DMPMDisplayPort 1.1a	Same
Miscellaneous Features/Specifications
USBPorts/standard	1 upstream (endpoint),2 downstream/ Rev. 2.0	1 upstream (endpoint),2 downstream/ Rev. 2.0	Same
Dimensions w/ostand(W x H x D)	Without stand:382mm x490mm x75mmWith stand:382mm x533mm x238mm	Without stand:382mm x490mm x77mmWith stand:382mm x635mm x238mm	Differenthousing designdue to thedifferent panelsize.
Indication foruse	JUSHA-M23C LCD Monitoris intended to be used indisplaying and viewingdigital images for diagnosisof X-ray or MRI, etc. bytrained medical practitioners.The device does not supportthe display of mammographyimages for diagnosis.	JUSHA-M260G LCDMonitor is intended to beused in displaying andviewing digital images fordiagnosis of X-ray or MRI,etc. by trained medicalpractitioners. The devicedoes not support the displayof mammography images fordiagnosis	Same

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Attributes	Predicate Device	Proposed Device	Discussion ofDifferences
Product	JUSHA-M23C	JUSHA-M260G	-
510(k) Number	K151238	/	-
Applicablestandard	1 IEC 60601-1Medical	1 IEC 60601-1:2012, EN
	equipment medical electrical	60601-1:2013, ANSI/AAMI
	equipment - Part 1: General	ES60601-1:2005+A1:2012+
	requirements for basic safety	C1:2009+A2:2010,
	and essential performance	CAN/CSA C22.2
	2005+CORR.1(2006)+COR	NO.60601-1:14, Medical
	R.2(2007)	equipment medical electrical
		equipment - Part 1: General
	2 IEC 60601-1-2 Edition	requirements for basic safety
	3:2007, Medical electrical	and essential performance.
	equipment - Part 1-2:
	General requirements for	2 IEC 60601-1-2 Edition
	basic safety and essential	4:2014, EN 60601-1-2:2015,
	performance - Collateral	CFR 47 FCC Part15 subpart
	standard: Electromagnetic	B: 2017, Medical electrical
	compatibility - Requirements	equipment - Part 1-2:
	and tests.	General requirements for
		basic safety and essential
		performance - Collateral
		standard: Electromagnetic
	disturbances - Requirements
	and tests.

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PERFORMANCE DATA:

The following performance data were provided in support of the substantial equivalence determination.

Bench testing:

Bench testing was conducted to demonstrate the JUSHA-M260G meets all performance standards as follows:

Measurement of the angular dependency of luminance response in horizontal, ● vertical and diagonal directions
Measurement of the luminance non-uniformity characteristics of the display screen as specified in TGI18 guideline.
Measurement of the chromaticity non-uniformity characteristics of the display ● screen as specified in TG18 guideline.
Measurement of small-spot contrast ratio. ●
Measurement of temporal response
. Performance data on luminance stability

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the JUSHA-M260G The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.

Animal and clinical study

The subject of this premarket submission, JUSHA-M260G, does not require animal or clinical studies to support substantial equivalence.

CONCLUSIONS

JUSHA-M260G Medical Display is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The non-clinical data support the safety of the device. The device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-M260G Medical Display does not raise any new issues of safety or effectiveness.

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Image /page/9/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 15, 2019

Nanjing Jusha Display Technology Co., Ltd. % Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St., Nanjing, Jiangsu 210036 CHINA

Re: K183497

Trade/Device Name: JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving And Communications System Regulatory Class: Class II Product Code: PGY Dated: December 20, 2018 Received: December 20, 2018

Dear Zilong Liang:

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.

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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).