JUSHA-M32 Medical Display 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 is not specified for digital mammography system.

Device Description

JUSHA-M32 Medical Display is the display system with the high resolution(2048 x 1536), high luminance(700 cd/m²), and 256 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table inside, the product is consisted of the following components:

21.3 inch, mono-TFT Liquid Crystal Display
Motherboard HDVI-3M V1.0
JUSHA-M32 Medical Display software
Power Adapter
Data Cable.
The Medical Display is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:

IEC 60601-1 Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 1988+A1: 1991 + A2:1995
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 text is a 510(k) Premarket Notification Submission for the JUSHA-M32 Medical Display. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about clinical studies with acceptance criteria and device performance as typically expected for algorithms or AI-driven diagnostic devices.

The submission explicitly states:
"Summary of Clinical Tests: The subject of this premarket submission, Medical Display, did not require clinical studies to support substantial equivalence."

Therefore, it is not possible to provide the requested information regarding acceptance criteria and device performance based on the provided text, as this device (a medical display monitor) did not undergo clinical studies for performance evaluation in the same way an AI diagnostic device would.

The document describes the device's technical specifications and compliance with voluntary standards for safety and performance (e.g., IEC 60601-1 for basic safety and essential performance, and IEC 60601-1-2 for electromagnetic compatibility). The substantial equivalence is determined based on these technical characteristics and non-clinical tests.

If this were an AI or diagnostic algorithm, the expected information would be:

A table of acceptance criteria and the reported device performance: This would list metrics like sensitivity, specificity, AUC, etc., and the performance achieved by the device.
Sample size used for the test set and the data provenance: Details about the number of cases/patients in the test set and whether the data was retrospective/prospective, and its origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Information about the clinicians who provided truth labels.
Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert decision).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: If so, the effect size of human readers' improvement with AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes/No.
The type of ground truth used: For example, expert consensus, pathology, or outcomes data.
The sample size for the training set: Number of cases/patients used to train the algorithm.
How the ground truth for the training set was established: Similar to the test set, but for the training data.

Since the JUSHA-M32 Medical Display is a display system and not a diagnostic algorithm requiring clinical performance evaluation, this information is not present in the 510(k) summary.

Summary

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510(k) Premarket Notification Submission

AUG 2 1 2013

510(k) Summary

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

Date:	Mar, 11,2013
Submitter:	Nanjing Jusha Display Technology Co., LtdAdd: 301, Hanzhongmen Street, 8F Block A, No.1, NanjingInternational Service Outsourcing Mansion, Nanjing, 210036China
Primary Contact Person:	Zhu chengshunQuality ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783271
Secondary ContactPerson:	Mike GuRegulatory ManagerGuangzhou Osmunda Medical Device Consulting Co., LtdTel: +86-20-62321333Fax: +86-20-86330253
Device Trade Name:	JUSHA-M32 Medical Display
Common/Usual Name:	Image display system, medical image workstation, imagemonitor/display, and others
Classification Name:Product Code:	System, image processing90LLZ
Predicate Device(s):	RADIFORCE GS310;K060845
Device Description:	JUSHA-M32 Medical Display is the display system with thehigh resolution(2048 x 1536), high luminance(700 cd/m²),and256 simultaneous shades of gray out of a palette of4096, 8 DICOM look up table inside, the product is consistedof the following components:- 21.3 inch, mono-TFT Liquid Crystal Display- Motherboard HDVI-3M V1.0- JUSHA-M32 Medical Display software- Power Adapter- Data Cable.The Medical Display is designed, tested, and will bemanufactured in accordance with both mandatory andvoluntary standards:

	1. IEC 60601-1 Medical equipment medical electricalequipment - Part 1: General requirements forbasic safety and essential performance 1988+A1:1991 + A2:1995
	2. IEC 60601-1-2 Edition 3:2007, Medical electricalequipment - Part 1-2: General requirements forbasic safety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements and tests.
Intended Use:	JUSHA-M32 Medical Display is intended to be used indisplaying and viewing digital images for diagnosis of X-rayor MRI, etc. by trained medical practitioners. The device isnot specified for digital mammography system.
Technology:	JUSHA-M32 Medical Display is the display system with thehigh resolution monitor (3 megapixels) with electroniccapabilities for evaluation of high resolution medical images,high luminance (700 cd/m²) and 256 simultaneous shadesof gray out of a palette of 4096, 8 DICOM look up tableinside
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:The Medical Display complies with voluntary standards asdetailed in Section 9, 11 and 17 of this premarketsubmission. The following quality assurance measures wereapplied 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, Medical Display,did not require clinical studies to support substantialequivalence.
	The proposed device is Substantially Equivalent (SE) to thepredicate device which is US legally market device.Therefore, the subject device is determined as safe andeffectiveness.
Conclusion:	Nanjing Jusha Display Technology Co., Ltd Considers theJUSHA-M32 Medical Display to be as safe, as effective, andperformance is substantially equivalent to the predicatedevice(s).

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510(k) Premarket Notification Submission

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510(k) Premarket Notification Submission

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Image /page/3/Picture/0 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 coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is relatively small compared to the caduceus symbol.

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

August 21, 2013

NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD % MIKE GU GUANGZHOU OSMUNDA MEDICAL DEVICE CONSULTING CO. 7TH FLOOR, 982. CONGYUN RD. BAIYUN DISTRICT GUANGZHOU, GUANGDONG CHINA CH 510420

Re: K131391

Trade/Device Name: JUSHA-M32 Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: July 15, 2013 Received: August 9, 2013

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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Page 2 - Mr. Mike Gu

forth in the quality systems (QS) 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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/dcfault.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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

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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Indications for Use

510(k) Number (if known): K131391

Device Name: JUSHA-M32 Medical Display

Indications for Use:

Prescription Use JJ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

(m.h.p)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K131391 510(k)_

Regulation Number and Section

N/A