JUSHA-MS2C Medical Display is intended to be used by trained physicians in various kinds of medical including digital mammography system for which the device complies with the performance specified by the manufacturer of the system.

Device Description

JUSHA-M52C Medical Display is the display system with the high resolution(2048 x 2560), 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-M52C 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 describes a 510(k) Premarket Notification Submission for the JUSHA-M52C Medical Display. This document focuses on demonstrating substantial equivalence to a predicate device based on technical performance and compliance with relevant standards, rather than clinical efficacy through studies with human readers or AI algorithms. As such, many of the requested criteria are not applicable or explicitly mentioned in this type of submission.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of a clinical or performance study with quantified thresholds. Instead, it demonstrates compliance with recognized standards and technical specifications that are implicitly accepted for a medical display device. The device's performance is reported in terms of its technical specifications.

Characteristic	Acceptance Criteria (Implied by Predicate & Standards)	Reported Device Performance (JUSHA-M52C)
Resolution	Similar to predicate device (RADIFORCE G51)	2048 x 2560 (5 megapixels)
Luminance	-	700 cd/m²
Shades of Gray	-	256 simultaneous shades of gray out of a palette of 4096
DICOM Look-Up Table	-	8 DICOM look-up table inside
Safety	Compliance with IEC 60601-1:1988+A1:1991+A2:1995	Complies with IEC 60601-1:1988+A1:1991+A2:1995
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2 Ed. 3:2007	Complies with IEC 60601-1-2 Ed. 3:2007

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

Not applicable. This submission is for a medical display, which is a hardware device. The "test set" in this context refers to testing of the hardware's compliance with technical specifications and safety standards, not a clinical dataset for an AI algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).

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

Not applicable. There is no "ground truth" established by medical experts for a test set in the context of a medical display's technical performance and safety testing. The evaluation is based on engineering and regulatory standards.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication in this submission.

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 device is a medical display, not an AI-powered diagnostic tool. No MRMC study was performed or required.

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

Not applicable. This device is a medical display, not a standalone algorithm.

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

Not applicable. The "ground truth" for this device's performance relates to its adherence to technical specifications and safety standards, which are objectively measurable and defined by industry and regulatory bodies (e.g., luminance, resolution, electrical safety).

8. The sample size for the training set

Not applicable. This device is a medical display, not a machine learning model. There is no "training set."

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

Not applicable. There is no "training set" or associated ground truth for this type of device.

Study Proving Acceptance Criteria:

The "study" proving the device meets its acceptance criteria (implicitly, substantial equivalence) is the non-clinical testing summarized in the submission. The submission states:

"Summary of Non-Clinical Tests: The Medical Display complies with voluntary standards as following: 1 IEC 60601-1 Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 1988+A1 : 1991 + A2:1995 2 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."
It also states, "JUSHA-M52C is substantially equivalent to RadiForce G51. M52C employs the maximum resolution values same as that of RadiForce G51. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1." The Attachment 1, though not provided in the excerpt, would be the direct comparison to the predicate.
Quality assurance measures applied to the development include: Risk Analysis, Requirements Reviews, Design Reviews, Raw materials verification, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), and Safety testing (Verification).

Conclusion:

This 510(k) submission demonstrates substantial equivalence for a medical display by documenting that its technical specifications (resolution, luminance, shades of gray, DICOM LUT) are comparable to a legally marketed predicate device (RADIFORCE G51) and that it complies with relevant safety and EMC standards (IEC 60601-1 and IEC 60601-1-2). Clinical studies, AI performance metrics, or "ground truth" from medical expert consensus are not typically part of the evidence for a medical display's substantial equivalence.

Summary

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

K131390
Page 1 of 3

510(k) Premarket Notification Submission

510(k) Summary

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

Date:	April 21,2013
Submitter:	Nanjing Jusha Display Technology Co., LtdAdd: 301, Hanzhongmen Street, 8F Block A. No.1, NanjingInternational Service Outsourcing Mansion. Nanjing, 210036China
Primary Contact Person:	Mike GuRegulatory ManagerGuangzhou Osmunda Medical Device Consulting Co., LtdTel: +86-20-62321333Fax: +86-20-86330253
Secondary ContactPerson:	Zhu chengshunQuality ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25-83305050Fax: +86-25-58783271	NOV 27 2013
Device Trade Name:	JUSHA-M52C Medical Display
Common/Usual Name:	Image display system, medical image workstation, imagemonitor/display, and others
Classification Name:Product Code:	System, image processing 21CFR 892.205090LLZ
Predicate Device(s):	RADIFORCE G51:K042755
Device Description:	JUSHA-M52C Medical Display is the display system withthe high resolution(2048 x 2560), high luminance(700cd/m²), and 256 simultaneous shades of gray out of a paletteof 4096, 8 DICOM look up table inside, the product isconsisted of the following components:- 21.3 inch, mono-TFT Liquid Crystal Display- Motherboard HDVI-3M V1.0- JUSHA-M52C 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 electrical equipment - Part 1: General requirements for basic 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 - Collateralstandard: Electromagnetic compatibility -Requirements and tests.
Intended Use:	JUSHA-M52C Medical Display is intended to be used bytrained physicians in various kinds of medical imageapplications including digital mammography system forwhich the device complies with the performance specified bythe manufacturer of the system.
Technology:	JUSHA-M52C Medical Display is the display system withthe high resolution monitor (5 megapixels) with electroniccapabilities for evaluation of high resolution medical images,high luminance (700 cd/m²) and 256 simultaneous shades ofgray out of a palette of 4096, 8 DICOM look up table inside
Determination ofSubstantial Equivalence:	Summary of Non-Clinical Tests:The Medical Display complies with voluntary standards asfollowing:1 IEC 60601-1 Medical equipment medical electricalequipment - Part 1: General requirements for basic safetyand essential performance 1988+A1 : 1991 + A2:19952 IEC 60601-1-2 Edition 3:2007, Medical electricalequipment Part 1-2: General requirements for basicsafety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests.JUSHA-M52C is substantially equivalent to RadiForce G51.G51. M52C employs the maximum resolution values same asthat of RadiForce G51. Comparison table of the principalcharacteristics of 2 devices is shown in the Attachment 1.
	Attachment 1The following quality assurance measures were applied tothe 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)
(k) Premarket Notification Submission
	• Safety testing (Verification)Summary of Clinical Tests:The subject of this premarket submission, Medical Display, 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-M52C Medical Display to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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

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

510(k

. . . . . .

and the comments of the comments of the comments of

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

Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a symbol that resembles a stylized human figure with outstretched arms, with three curved lines above it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

November 27, 2013

Nanjing Jusha Display Technology Co., Ltd. % Mr. Mike Gu Regulatory Manager Guangzhou Osmunda Medical Device Consulting Co., Ltd. 710 Floor, 982 Congyun Road Baiyun District Guangzhou, Guangdong 510420 CHINA

Re: K131390

Trade/Device Name: JUSHA-M52C Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 24, 2013 Received: September 30, 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 r ou may more or ovisions 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in and ation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

Page 2-Mr. Gu

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/ResourcessiorYou/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/Reportal?roblem/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 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.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.hum.

Sincerely yours,

Sm. 7)

for

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

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K131390

Device Name JUSHA-M52C Medical Display

Indications for Use (Describe)

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)

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)

FORM FDA 3881 (9/13)

PKC Palishing Seringer ( U1) 1 4614.741 ម

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).