JUSHA-M53 Medical Display is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

Device Description

JUSHA-M53 Medical Display is a display system with the high resolution (2560 x 2048), high luminance (1000 cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table with 12 bit inside. It is compliant with DICOM Part 14, and it has front sensor, presents induction system and ambient brightness adapting function. JUSHA-M53 employs energy efficient LED as backlight, it can achieve a high brightness and low power consumption at the same time. LED backlights deteriorate more slowly and thus the monitor offers a long service time.JUSHA-M53 with 10 bit (1024 tones) simultaneous grayscale display extends graysacle fidelity to the boundaries of human visual perception abilities and helps radiologists discern the finest nuances within an image.

The product is consisted of the following components:

21.3 inch, mono-TFT Liquid Crystal Display
-JUSHA-45T Motherboard/FR-4/REV1.0
JUSHA-M53 Medical Display software
Power Adapter
Data Cable.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is present and what is not explicitly detailed:

Device: JUSHA-M53 Medical Display

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the JUSHA-M53 beyond general compliance with industry standards and substantial equivalence to the predicate device. However, a detailed comparison table of technological characteristics to the predicate device (Eizo Nanao Corporation's RadiForce GX540, K130336) is provided, implying these are the performance metrics against which "acceptance" for substantial equivalence is being measured.

Feature / Metric	Predicate Device (RADIFORCE GX540)	Proposed Device (JUSHA-M53 Medical Display)	Performance (as reported for JUSHA-M53)	Acceptance Criteria (Implied from Predicate Comparison)	Met (Y/N)
Screen technology	21.3" TFT Monochrome LCD Panel	21.3" TFT Monochrome LCD Panel	21.3" TFT Monochrome LCD Panel	Same as predicate	Y
Viewing angle (H,V)	Horizontal 176°, Vertical 176°	Horizontal 176°, Vertical 176°	Horizontal 176°, Vertical 176°	Same as predicate	Y
Resolution	2048 x 2560	2048 x 2560	2048 x 2560	Same as predicate	Y
Display area	337.9 x 422.4 mm	337.9 x 422.4 mm	337.9 x 422.4 mm	Same as predicate	Y
Aspect ratio	4:5	4:5	4:5	Same as predicate	Y
Contrast Ratio (typ)	1200:1	1200:1	1200:1	Same as predicate	Y
Recommended brightness	500cd/m²	500cd/m²	500cd/m²	Same as predicate	Y
Pixel Pitch	0.165 x 0.165 mm	0.165 x 0.165 mm	0.165 x 0.165 mm	Same as predicate	Y
Backlighting	LED backlight	LED backlight	LED backlight	Same as predicate	Y
Grayscale	1024	1024	1024	Same as predicate	Y
Response time	25ms	25ms	25ms	Same as predicate	Y
Sensors	Backlight, Integrated front, Presence, Ambient light	Backlight, Integrated front, Presence, Ambient light	Backlight, Integrated front, Presence, Ambient light	Same as predicate	Y
Input signals	DVI standard 1.0	DVI standard 1.0	DVI standard 1.0	Same as predicate	Y
Input termination	1 DVI-D Dual Link, 1 Display Port	1 DVI-D Dual Link, 1 Display Port	1 DVI-D Dual Link, 1 Display Port	Same as predicate	Y
Display controller	Off the shelf	Off the shelf	Off the shelf	Same as predicate	Y
Scanning Freq. (H,V) (Predicate)	31-135 kHz / 24-61 Hz	123 KHz / 60 Hz	123 KHz / 60 Hz	To be demonstrated as acceptable for medical imaging	Y (Implied)
Power Requirement	100-120 Vac, 50/60 Hz, 1.1-0.9A; 200-240 Vac, 50/60 Hz, 0.6-0.5A	100-120 Vac, 50/60 Hz, 1.1-0.9A; 200-240 Vac, 50/60 Hz, 0.6-0.5A	100-120 Vac, 50/60 Hz, 1.1-0.9A; 200-240 Vac, 50/60 Hz, 0.6-0.5A	Same as predicate	Y
Power Consumption/Save Mode (Predicate)	108W / less than 0.7W	48.9W / less than 1.5W	48.9W / less than 1.5W	Lower/comparable consumption is generally favorable	Y (Improved efficiency)
Power Management	DVI DMPM	DVI DMPM	DVI DMPM	Same as predicate	Y
USB Ports/standard	1 upstream (endpoint), 2 downstream	1 upstream (endpoint), 2 downstream	1 upstream (endpoint), 2 downstream	Same as predicate	Y
Indications for use	Displaying & viewing digital images, including digital mammography, for review & analysis by trained medical practitioners	Displaying & viewing digital images, including digital mammography, for review & analysis by trained medical practitioners	Same as predicate	Same as predicate	Y
Applicable Standards	IEC 60601-1, IEC 60601-1-2	IEC 60601-1, IEC 60601-1-2	Complies with both standards	Compliance with standards	Y

The key acceptance criterion seems to be "substantial equivalence" to the predicate device, demonstrated by matching or comparable technological characteristics and compliance with relevant safety and EMC standards.

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

The document specifies "Bench testing" was conducted on the JUSHA-M53. However, it does not provide details on the sample size (e.g., number of displays tested) nor the data provenance. It describes performance data as being obtained from the device itself.

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

This information is not applicable as the testing described is bench testing of a medical display, not a clinical study involving human interpretation of images and ground truth established by experts.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3.

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 information is not applicable. The device is a medical display, not an AI-powered diagnostic or assistive tool. No MRMC study was mentioned.

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

This information is not applicable. The device is a medical display, not an algorithm.

7. The type of ground truth used

The document describes "Bench testing" for physical and electrical performance (luminance response, uniformity, contrast ratio, temporal response, stability, electrical safety, EMC). The "ground truth" for these tests would be the measurement standards and technical specifications (e.g., TG18 guideline for display characteristics, IEC 60601 series for safety/EMC). There is no "pathology" or "outcomes data" ground truth involved, as it is a display device, not an image interpretation algorithm or a treatment.

8. The sample size for the training set

This information is not applicable. The device is a medical display, not a machine learning model that requires a training set.

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

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

April 28, 2015

Nanjing Jusha Display Technology Co., Ltd. % Mr. Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technology Services Co., Ltd. 7th Floor, Jingui Business Building No. 982 Congyun Road, Baiyun District Guangzhou, Guangdongg 510420 CHINA

Re: K150842

Trade/Device Name: JUSHA-M53 Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 27, 2015 Received: March 30, 2015

Dear Mr. Gu:

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,

Robert A Ochs

Robert Ochs, Ph.D. Acting 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

510(k) Number (if known) K150842

Device Name JUSHA-M53 Medical Display

Indications for Use (Describe)

JUSHA-M53 Medical Display is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

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)

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)

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510(k) Summary

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

l. SUBMITTER

Nanjing Jusha Display Technology Co., Ltd.

301, Hanzhongmen Street, 8F Block A, No.1, Nanjing International Service Outsourcing Mansion, Nanjing, 210036 China

Phone: (+86) 25- 83305050

Fax: (+86) 25- 58783271

Primary Contact Person:	Mike Gu
-------------------------	---------

Regulatory Affairs Manager

OSMUNDA Medical Device Consulting Co., Ltd

Tel: (+86) 20-6232 1333

Fax: (+86) 20-8633 0253

Jing Ma Secondary Contact Person:

Certification Engineer

Nanjing Jusha Display Technology Co., Ltd

Date Prepared: March 23, 2015

II. DEVICE
Name of Device: JUSHA-M53 Medical Display

Common/Usual Name: Display, 5M Grayscale Flat panel Display
System, image processing (21 CFR 892.2050) Classification Names:
Regulation Class:
Product Code: LLZ
III. PREDICATE DEVICE

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Eizo Nanao Corporation's RadiForce GX540, K130336

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The product is consisted of the following components:

21.3 inch, mono-TFT Liquid Crystal Display
-JUSHA-45T Motherboard/FR-4/REV1.0
JUSHA-M53 Medical Display software
Power Adapter
Data Cable.

V. INDICATIONS FOR USE

JUSHA-M53 Medical Display is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

JUSHA-M53 Medical Display is the display system with the high resolution (2560 x 2048) monitor (5 megapixels) with electronic capabilities for evaluation of high resolution medical images. It uses a monochrome LCD panel with IPS (in-plane switching) technology, so that it can

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achieve wide viewing angles. JUSHA-M53 has a backlight sensor inside to stabilize the set luminance level automatically. JUSHA-M53 also has an integrated front sensor used for independent grayscale. With high luminance (1000 cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table with 12 bit, DSA, DSI and CT/MRI-JS curve which are calibrated in our factory are stored -inside the display.JUSHA-M53 has a ambient brightness sensor used to adjust the luminance and DICOM LUT along with the ambient brightness changing when the ambient function is enable. It has a brightening quickly button which can adjust the luminance and curve when press the button, this can be used to switch the using mode between high luminance and low luminance level, the is luminance used for diagnosis, the low luminance level is used for normal reading.JUSHA-M53 has an infrared sensor to detect whether there is a person in front of the display, it is working when there is a person, and it will be in power saving mode if there is no person in front of it. The JUSHA-M53 employs the same technology as its predicate devices K130336.

Items	Predicate Device	Proposed Device
Product	RADIFORCE GX540	JUSHA-M53 Medical Display
510(k) Number	K130336	/
Display Performance/Specifications
Screen technology	21.3"TFT MonochromeLCD Panel	21.3"TFT Monochrome LCD Panel
Viewing angle (H,V)	Horizontal176°, Vertical 176°	Horizontal 176°, Vertical 176°
Resolution	$2048\times2560$	$2048\times2560$
Display area	$337.9\times 422.4$ mm	$337.9 \times 422.4$ mm
Aspect ratio	4:5	4:5
Contrast Ratio(typ)	1200:1	1200:1
Recommended brightness	500cd/m²	500cd/m²
Pixel Pitch	$0.165\times0.165$ mm	$0.165\times0.165$ mm
Backlighting	LED backlight	LED backlight
grayscale	1024	1024
Response time	25ms	25ms
Sensor	Backlight sensor,Integrated front sensor,Presence sensor,Ambient light sensor	Backlight sensor, Integrated frontsensor, Presence sensor, Ambientlight sensor
Video Signal Input
Input signals	DVI standard 1.0	DVI standard 1.0
Input terminational	1 DVI-D Dual Link1 Display Port	1 DVI-D Dual Link1 Display port
Display controller	Off the shelf	Off the shelf
Scanning Frequency (H,V)	31 - 135 kHz /24 -61 HzFrame synchronousmode: 24.5 - 25.5 Hz, 49-51 Hz	123KHz/60Hz
Power Related Specification
Power Requirement	100 - 120 Vac ±10%,50/60 Hz 1.1 - 0.9A200 - 240 Vac ±10%,50/60 Hz 0.6 - 0.5A	100 - 120 Vac ±10%, 50/60 Hz 1.1 -0.9A200 - 240 Vac ±10%, 50/60 Hz 0.6 -0.5A
Power Consumptions/SaveMode	108W/less than 0.7W	48.9W/less than 1.5W
Power Management	DVI DMPM	DVI DMPM
Miscellaneous Features/Specifications
USB Ports/standard	1 upstream (endpoint),2 downstream	1 upstream (endpoint), 2downstream
Dimensions w/o stand(W x H x D)	With stand:	With stand:
	338×512-595×245.5	395×238×530
	Without stand:	Without stand:
	688.5×496×99 mm	395×74×491
Indication for use	RadiForce GX540 isintended to be used indisplaying and viewingdigital images, includingthose of digitalmammography, forreview and analysis bytrained medicalpractitioners.	JUSHA-M53 Medical Display isintended to be used in displayingand viewing digital images, includingthose of digital mammography, forreview and analysis by trainedmedical practitioners.
Applicable standard	1 IEC 60601-1Medicalequipment medicalelectrical equipment -Part 1: Generalrequirements for basicsafety and essentialperformance 1988+A1 :1991 + A2:19952 IEC 60601-1-2 Edition3:2007, Medicalelectrical equipment -Part 1-2: Generalrequirements for basicsafety and essentialperformance -Collateral standard:Electromagneticcompatibility -Requirements andtests.	1 IEC 60601-1Medical equipmentmedical electrical equipment - Part1: General requirements for basicsafety and essential performance1988+A1 : 1991 + A2:19952 IEC 60601-1-2 Edition 3:2007,Medical electrical equipment - Part1-2: General requirements for basicsafety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements andtests.

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VII. 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-M53 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-M53. 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-M53, does not require animal or clinical studies to support substantial equivalence.

VIII. CONCLUSIONS

JUSHA-M53 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 should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-M53 Medical Display does not raise any new issues of safety or effectiveness.

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).