(22 days)
JUSHA-M52C Medical Display is intended to be used for review and analysis by trained medical practitioners in displaying and viewing various kinds of medical images including digital mammography system.
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.
This document is a 510(k) Pre-Market Notification from the FDA for a medical display device, the JUSHA-M52C Medical Display. As such, it does not contain a study proving that the device meets specific acceptance criteria in the way a clinical study for a new medical algorithm would.
Instead, the submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device (JUSHA-M52C; K131390, and mentions RadiForce G51 as a comparison for resolution values) by meeting relevant performance standards and safety requirements.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria in the sense of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic algorithm. Instead, it details the technical specifications of the device and its compliance with relevant medical device standards.
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (JUSHA-M52C Medical Display) |
|---|---|
| Technical Specifications: | |
| Resolution | 2048 x 2560 (5 megapixels) |
| Luminance | 700 cd/m² |
| Grayscale Shades (simultaneous) | 256 out of a palette of 4096 |
| DICOM Look-Up Tables | 8 DICOM look up table inside |
| Compliance with Standards: | |
| Basic Safety & Essential Performance (IEC 60601-1) | Complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) / EN 60601-1: 2006/AC: 2010 |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2 Edition 3:2007 |
| Equivalence to Predicate Device: | |
| Resolution consistency with predicate | "M52C employs the maximum resolution values same as that of RadiForce G51." |
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 this submission is for a medical display, not an AI/software algorithm that analyzes medical data. Therefore, there is no "test set" of medical images or patient data in the context of evaluation for a diagnostic algorithm. The testing described focuses on hardware and software functionality and compliance with engineering standards.
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 information is not applicable. As explained above, there is no "test set" requiring ground truth established by medical experts for this type of device submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. There is no medical image 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
This information is not applicable. An MRMC study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance. This submission is for a medical display device, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This document describes a medical display, which is a hardware device for viewing images, not a standalone AI algorithm. Its function is to present images for human interpretation, not to perform independent diagnostic analysis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The device itself does not perform diagnostics requiring ground truth. Its performance validation is based on technical specifications and compliance with safety and performance standards for display technology.
8. The sample size for the training set
This information is not applicable. This device is a medical display, not a machine learning model. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, there is no training set for a machine learning model for this device.
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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 14, 2015
Nanjing Jusha Display Technology Co., LTD % Mr. Ma Jing Certification Engineer 301 Hanzhongmen Street, 8F Block A. No.1 Nanjing International Service Outsourcing MANSION, NANJING 210036 CHINA
Re: K150746
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: PGY Dated: March 16, 2015 Received: March 23, 2015
Dear Mr. Jing:
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 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.
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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, PhD. 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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Indications for Use
510(k) Number (if known) K150746
Device Name JUSHA-M52C Medical Display
Indications for Use (Describe)
JUSHA-M52C Medical Display is intended to be used for review and analysis by trained medical practitioners in displaying and viewing various kinds of medical images including digital mammography system.
| 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)
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | July 21,2013 |
|---|---|
| Submitter: | Nanjing Jusha Display TechnologyCo., LtdAdd: 301, Hanzhongmen Street, 8F Block A, No.1, NanjingInternational Service Outsourcing Mansion, Nanjing, 210036China |
| Contact Person: | Ma JingCertification engineer301, Hanzhongmen Street, 8F Block A, No.1, NanjingInternational Service Outsourcing Mansion, Nanjing, 210036ChinaTel: +86-25-83305050,fax +86-25-58783271 |
| 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): | JUSHA-M52C;K131390 |
| Device Description: | JUSHA-M52C Medical Display is the display system with thehigh resolution(2048 x 2560), high luminance(700 cd/m² ),and 256 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-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 60601-1Medical equipment medical electricalequipment - Part 1: General requirements forbasic safety and essential performanceIEC 60601-1:2005 + CORR. 1 (2006) +CORR. 2 (2007)/ | |
| EN 60601-1: 2006/AC: 2010 | |
| 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-M52C Medical Display is intended to be used forreview and analysis by trained medical practitioners indisplaying and viewing various kinds of medical imagesincluding digital mammography system. |
| Technology: | JUSHA-M52C Medical Display is the display system with thehigh resolution monitor (5 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 asfollowing:1 IEC 60601-1Medical equipment medical electricalequipment - Part 1: General requirements for basicsafety and essential performance | |
| IEC 60601-1:2005 + CORR. 1 (2006) +CORR. 2 (2007)/ | |
| EN 60601-1: 2006/AC: 2010 | |
| 2 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 1 | |
| The following quality assurance measures were applied tothe development of the system:• Risk Analysis• Requirements Reviews |
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| •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-M52C Medical Display to be as safe, as effective, andperformance is substantially equivalent to the predicatedevice(s). |
§ 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).