(63 days)
JUSHA-C630G/JUSHA-C630G/C630/C630 LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRL, et. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is the display system with the high resolution (3280×2048), high luminance (1050 cd/m2), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, C630G contains GAMMA2.2/GAMMA2.4 LUT. In addition, C630G has ambient brightness adaptation inside, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results. The product is consisted of the following components: - 30" Color TFT LCD Panel - DMX0704AR0/main board/REV:1.1 - JUSHA-C630G LCD Monitor software - Power Adapter - Data Cable. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements 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 electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
Based on the provided FDA 510(k) summary for the Nanjing Jusha Display Technology Co., Ltd. JUSHA-C630G LCD Monitor, here's an analysis of the acceptance criteria and study proving they are met:
This document is for a medical display device (LCD monitor), not an AI algorithm for image analysis. Therefore, many of the typical questions for an AI device's performance study (such as sample size for test/training sets, experts for ground truth, MRMC studies, etc.) are not applicable to this type of device. The "study" here primarily refers to bench testing to ensure the monitor meets display performance standards.
The primary method for demonstrating substantial equivalence for this device is bench testing against established industry standards and comparison to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from "Bench testing" section) | Reported Device Performance (from "Bench testing" section) |
|---|---|
| Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions | The device "meets all performance standards" and "complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC." (Specific numerical performance values are not provided in this summary, but the report states it meets the standards.) |
| Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline. | Same as above. |
| Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline. | Same as above. |
| Measurement of small-spot contrast ratio. | Same as above. |
| Measurement of temporal response | Same as above. |
| Performance data on luminance stability | Same as above. |
| Electrical safety (compliance with IEC 60601-1) | Complies with IEC 60601-1 standard for safety. |
| Electromagnetic compatibility (EMC) (compliance with IEC 60601-1-2) | Complies with IEC 60601-1-2 standard for EMC. |
Note: The 510(k) summary asserts that the device meets the performance standards, but does not explicitly provide the numerical results of each test. This is common in 510(k) summaries, where the detailed test reports are submitted to the FDA for review, and the summary highlights the conclusion of compliance.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable in the context of image data for an AI algorithm. This is a hardware device (LCD monitor). The "sample" would be the manufactured unit(s) themselves undergoing physical and electrical bench testing. The document does not specify the number of units tested.
- Data Provenance: Not applicable in the context of patient data. The "data" are measurements taken from the display device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. Ground truth in this context is established by objective measurements based on standards (like AAPM TG18, IEC 60601-1, IEC 60601-1-2) performed by qualified technicians/engineers using calibrated equipment. It does not involve human interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This refers to the resolution of discrepancies in expert labeling of medical images, which is not relevant for a display performance study.
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
- MRMC Study: Not applicable. MRMC studies are used to evaluate diagnostic accuracy and reader performance with AI assistance, which is not the purpose of evaluating a diagnostic display.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a display monitor, not an AI algorithm. Its performance is inherent to its physical and electronic characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth for this device's performance is based on established industry and international standards for medical displays (e.g., AAPM TG18 guidelines for display quality; IEC 60601-1 for electrical safety; IEC 60601-1-2 for EMC). Compliance with these objective, measurable benchmarks constitutes the "ground truth" for a display device.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable for the reasons stated above.
Summary for this specific device:
The FDA 510(k) for the JUSHA-C630G LCD Monitor relies on bench testing to confirm compliance with recognized performance and safety standards for medical display devices (e.g., AAPM TG18, IEC 60601-1, IEC 60601-1-2). This assessment ensures the monitor can accurately and safely display medical images for diagnostic purposes. It is explicitly stated that no animal or clinical studies were required to support substantial equivalence for this type of device, as its equivalence is based on technical specifications and adherence to established standards, demonstrating it does not raise new questions of safety or effectiveness compared to its predicate device.
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Nanjing Jusha Display Technology Co., Ltd. Donny Lee Certification Engineer 8A, Block 1, 301 Hanzhongmen Street Nanjing, Jiangsu 210036 China
September 19, 2022
Re: K222121
Trade/Device Name: C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: July 18, 2022 Received: July 18, 2022
Dear Donny Lee:
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.
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Lamb. Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K222121
Device Name C630G/JUSHA-C630G/C630/JUSHA-C630 LCD Monitor
Indications for Use (Describe)
IUSHA-C630G/USHA-C630G/C630/C630 LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRL, et. 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: | July 12, 2022 | |
|---|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., LtdAdd: 8A, Block 1. Nanjing International Service Outsourcing Mansion,No. 301, Hanzhongmen street, Nanjing City, Jiangsu Province, 210036China. | |
| Contact Person: | Donny LeeCertification EngineerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783273 | |
| Device Trade Name: | JUSHA-C630G LCD Monitor, JUSHA-C630 LCD Monitor,C630G LCD Monitor, C630 LCD Monitor | |
| Common/Usual Name: | 6MP Color LCD Monitor | |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 | |
| Product Code: | PGY | |
| Predicate Device(s): | JUSHA-C620G; K183492 | |
| Device Description: | JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is thedisplay system with the high resolution (3280×2048), high luminance(1050 cd/m2), and 281.47 trillion colors, built-in DICOM standardLUT. In particular, C630G contains GAMMA2.2/GAMMA2.4 LUT.In addition, C630G has ambient brightness adaptation inside, real-timeDICOM automatic calibration, full-screen brightness equalization andpresence induction system, therefore this display automatically adjustaccording to different requirements to achieve the best results.The product is consisted of the following components:- 30" Color TFT LCD Panel- DMX0704AR0/main board/REV:1.1- JUSHA-C630G LCD Monitor software- Power Adapter- Data Cable.The LCD Monitor is designed, tested, and will be manufactured inaccordance 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, CFR47 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-C630G/JUSHA-C630/C630G/C630 LCD Monitor is intendedto be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does notsupport the display of mammography images for diagnosis. | |
| Technology: | JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is thedisplay system with the high resolution $(3280\times2048)$ , high luminance(1050 cd/m²), and 281.47 trillion colors, built-in DICOM standardLUT. In particular, C630G contains GAMMA2.2/GAMMA2.4 LUT.In addition, C630G has ambient brightness adaptation inside, real-timeDICOM automatic calibration, full-screen brightness equalization andpresence induction system, therefore this display automatically adjustaccording to different requirements 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/AAMI ES60601-1:2005+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 47 FCCPart15 subpart B: 2017, Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance -Collateral standard: Electromagnetic disturbances - Requirementsand tests.JUSHA-C630G/ JUSHA-C630/ C630G/ C630 LCD Monitor issubstantially equivalent to JUSHA-C620G. Comparison table of theprincipal characteristics of two devices is shown in the Attachment 1 | |
| 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 C630G LCD Monitor to be safe and effective, and its performance is substantially equivalent to the predicate device(s). |
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12.1 Product Comparison
This comparison identifies the similarities and differences of the proposed JUSHA-C630G LCD Monitor device to the legally marketed predicate JUSHA-C620G LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | JUSHA-C620G | JUSHA-C630G/JUSHA-C630/C630G/C630 LCDMonitor | |
| 510(k) Number | K183492 | K222121 | |
| Screentechnology | 30" Color TFT LCD Panel | 30" Color TFT LCD Panel | Same |
| Viewing angle(H, V) | Horizontal 170°, Vertical170° | Horizontal 170°, Vertical170° | Same |
| Resolution | 3280 x 2048 | 3280 x 2048 | Same |
| Display area | 645.5 (H) x403.0 (V) mm | 645.5(H)×403.0(V)mm | Same |
| Contrast Ratio | 1000:1 | 1000:1 | Same |
| RecommendedLuminance | 500cd/m² | 500cd/m² | Same |
| Pixel Pitch | 0.197x0.197 mm | 0.197×0.197mm | Same |
| Backlight | LED | LED | Same |
| Display Colors | 16-bit, 281.47 trillion colors | 16-bit, 281.47 trillion colors | Same |
| Luminancecalibration | Built in calibration sensorprovided | Built in calibration sensorprovided | Same |
| Video Signal Output | |||
| Output signals | DisplayPort x 1 | DisplayPort x 1 | Same |
| Displaycontroller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA-C620G | JUSHA-C630G/JUSHA-C630/C630G/C630 LCDMonitor | |
| 510(k) Number | K183492 | K222121 | |
| PowerRequirement | AC 100 | 24V DC | The differencescaused bycomponents usedin the LCDMonitor. Thisonly shows thepowerrequirement isdifferent, notraising differentquestions of itssafety andeffectiveness. |
| PowerConsumption/Save Mode | 150W/less than 0.5W | 150W/less than 0.5W | Same |
| PowerManagement | DVI DMPM | DVI DMPM | Same |
| DisplayPort 1.1a | DisplayPort 1.2 | ||
| Miscellaneous Features/Specifications | |||
| USBPorts/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | Same |
| Dimensions w/o | Without stand: | Without stand: | Different |
| stand | housing design | ||
| (W x H x D) | 721.5mm×493.5mm×110mm | 705mm×477mm×77mmWith stand: | which hasnothing to dowith the display |
| With stand:721.5mm×585mm×262mm | 705mm×567mm×262mm | function. | |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA-C620G | JUSHA-C630G/JUSHA-C630/C630G/C630 LCDMonitor | |
| 510(k) Number | K183492 | K222121 | |
| Indication foruse | JUSHA-C620G 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. | JUSHA-C630G 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 |
| Applicablestandard | 1 IEC 60601-1:2012, EN60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2NO.60601-1:14, Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.2 IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,CFR 47 FCC Part15 subpartB: 2017, Medical electricalequipment - Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic disturbances | 1 IEC 60601-1:2012, EN60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2NO.60601-1:14, Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.2 IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,CFR 47 FCC Part15 subpartB: 2017, Medical electricalequipment - Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic disturbances | Same |
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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-C630G 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 TG18 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-C630G 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-C630G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor.
or 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-C630G Medical Display does not raise any new issues of safety or effectiveness.
§ 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).