(64 days)
JUSHA-C23C LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
JUSHA-C23C LCD Monitor is the display system with the high resolution (1600*1200), high luminance 600cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table and 3 GAMMA look up table inside. JUSHA-C23C has ambient brightness adapting and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results.
The product is consisted of the following components:
- 21.3inches, Color-TFT LCD Panel
- JUSHA-SMS_19inch motherboard/FR-4/REV:0.1
- JUSHA-C23C 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:
- IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005+CORR.1(2006)+CORR.2(2007)
- 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.
This document is a 510(k) Premarket Notification from the FDA regarding the "JUSHA-C23C LCD Monitor". It largely focuses on demonstrating substantial equivalence to a predicate device ("RADIFORCE RX240").
Here's an analysis based on your request, highlighting the information available and what is not present (which is typical for a display monitor 510(k) submission, as they generally don't involve complex AI models or extensive clinical studies in the same way an AI-powered diagnostic device would):
Key takeaway for this specific document: This application is for an LCD monitor. The "acceptance criteria" and "study" are focused on demonstrating the monitor's display performance and adherence to safety/EMC standards, not on an AI algorithm's diagnostic performance. Therefore, many of your requested points related to AI/MRMC studies or expert ground truth for diagnostic accuracy are not applicable to this kind of device.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present an explicit "acceptance criteria" table in the way one might for a diagnostic AI. Instead, it demonstrates compliance through comparisons to a predicate device and adherence to recognized standards. The key performance aspects are listed as "Bench testing" results, aiming to show that the monitor performs adequately for medical image display.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Display Performance | ||
| Resolution | Equivalent to predicate (1600x1200/1200x1600) | 1600x1200/1200x1600 |
| Screen Technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel |
| Viewing Angle (H, V) | Horizontal 176°; Vertical 176° | Horizontal 176°; Vertical 176° |
| Display Area | 432.0 (H) x 324.0 (V) mm | 432.0 (H) x 324.0 (V) mm |
| Recommended Luminance | 400 cd/m² | 400 cd/m² |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm |
| Backlight | LED | LED |
| DICOM LUT | At least 10-bit (1024 shades) or better than predicate | 12-bit (4096 shades) |
| Luminance Calibration | Built-in calibration sensor provided | Built-in calibration sensor provided |
| Contrast Ratio | Comparable to predicate (1200:1) | 1400:1 (Better than predicate, justified by different panel) |
| Scanning Freq. (H; V) | Acceptable range (Predicate: 31-100 kHz; 59-61Hz) | 52-76 kHz; 59-61Hz (Difference noted but deemed not affecting display function) |
| Bench Test Measurements | Meet standards/guidelines (e.g., TG18 guideline) | Passed: Measurement of angular dependency, luminance non-uniformity, chromaticity non-uniformity, small-spot contrast ratio, temporal response, luminance stability |
| Electrical Safety | Compliance with IEC 60601-1 | Complies with IEC 60601-1 |
| EMC | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Power Requirement | AC 100-240V 50-60Hz | AC 100-240V 50-60Hz |
| Power Consumption | Acceptable (Predicate: 52W/less than 1.6W) | 65W/less than 2.5W (Difference noted but deemed not affecting display function) |
Study Details (Focusing on Display Monitor Testing)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of diagnostic images/patient cases. The "test set" here refers to the physical monitor undergoing various bench tests. These tests are performed on the device itself.
- Data Provenance: Not applicable for a display monitor. The "data" are the measurements of the monitor's performance characteristics. This device is manufactured in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For a display monitor, "ground truth" is measured by calibrated instruments against physical and electrical performance standards (e.g., luminance, resolution, color accuracy). It's not about clinical interpretation by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies where human readers interpret medical images. For a monitor, test results are objective measurements.
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:
- No. An MRMC study is relevant for AI-powered diagnostic devices where the AI assists human readers in diagnosis. This document is for an LCD monitor, which is a display component and not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI algorithm; it's a medical display monitor. Standalone performance testing would refer to the monitor's physical and electrical characteristics as listed in the bench testing section.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical/Electrical Standards and Measurements. The "ground truth" for a display monitor's performance is adherence to established technical specifications and internationally recognized standards for medical displays (e.g., DICOM Part 14, TG18 guidelines, IEC 60601 series). These are objective, measurable criteria.
8. The sample size for the training set:
- Not applicable. This device is an LCD monitor, not an AI algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, there is no ground truth established in this context. The "ground truth" for the monitor's acceptable performance is defined by industry standards and regulatory requirements for medical displays.
In summary: This document clearly describes a 510(k) submission for a medical display monitor. The "acceptance criteria" and "study" described are focused on proving the monitor's technical specifications meet declared performance, are safe, and are electromagnetically compatible, aligned with relevant IEC standards and comparisons to a legally marketed predicate device. The nature of the device (a display hardware component) means that aspects related to complex AI algorithms, clinical diagnostic accuracy, human reader studies, or expert ground truth for interpretation are not within the scope of this submission.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 10, 2015
Nanjing Jusha Display Technology Co., Ltd. % Ma Jing Certification Engineer 301 Hnazhongmen Street, 8F Block A, No. 1 Nanjing International Service Outsourcing Mansion, Nanjing Jiangsu 210036 CHINA
Re: K151861
Trade/Device Name: JUSHA-C23C LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: August 13, 2015 Received: August 17, 2015
Dear Ma 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
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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 Oals
Robert Ochs, Ph.D. 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) K151861
Device Name JUSHA-C23C LCD Monitor
Indications for Use (Describe)
JUSHA-C23C LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRI, etc. 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: | May 6, 2014 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Contact Person: | Ma Jing |
| Certification Engineer | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Add: 8A, Block 1. Nanjing International Service OutsourcingMansion, No. 301, Hanzhongmen street, Nanjing, China. | |
| Fax: +86-25- 58783271 | |
| Device Trade Name: | JUSHA-C23C LCD Monitor |
| Common/Usual Name: | 2MP Color LCD Monitor |
| Classification Name: Product | System, image processing 21CFR 892.2050 |
| Code: | PGY |
| Predicate Device(s): | RADIFORCE RX240; K113844 |
| Device Description: | JUSHA-C23C LCD Monitor is the display system with the highresolution (1600*1200), high luminance 600cd/m²), and 1024simultaneous shades of gray out of a palette of 4096, 8 DICOM lookup table and 3 GAMMA look up table inside. JUSHA-C23C has |
| ambient brightness adapting and presence induction system, withthese this display can automatic adjustment according to differentrequirements in order to achieve the best results. | |
| The product is consisted of the following components: | |
| - 21.3inches, Color-TFT LCD Panel | |
| - JUSHA-SMS_19inch motherboard/FR-4/REV:0.1 | |
| - JUSHA-C23C 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 60601-1Medical equipment medical electricalequipment - Part 1: General requirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007)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. | |
| Intended Use: | JUSHA-C23C LCD Monitor is intended to be used in displaying andviewing digital images for diagnosis of X-ray or MRI, etc. by trainedmedical practitioners. The device does not support the display ofmammography images for diagnosis. |
| Technology: | JUSHA-C23C LCD Monitor is the display system with the highresolution monitor (2 megapixels) with electronic capabilities forevaluation of high resolution medical images, high luminance (600cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096,8 DICOM look up table and 3 GAMMA look up table inside. Inparticular, JUSHA-C23C LCD Monitor contains CGA function, it isspecially made by JUSHA, it can automatic identify gray and colorsignals, then gray area calls DICOM LUT and color area callsGAMMA2.2 LUT. JUSHA-C23C has ambient brightness adaptingand presence induction system, with these this display can automaticadjustment according to different requirements in order to achieve thebest results. |
| Determination of SubstantialEquivalence: | Summary of Non-Clinical Tests:The LCD Monitor complies with voluntary standards as following:1 IEC 60601-1Medical equipment medical electrical equipment -Part 1: General requirements for basic safety and essentialperformance 2005+CORR.1(2006)+CORR.2(2007)2 IEC 60601-1-2 Edition 3:2007, Medical electrical equipment -Part 1-2: General requirements for basic safety and essentialperformance - Collateral standard: Electromagnetic compatibility- Requirements and tests.JUSHA-C23C is substantially equivalent to RADIFORCE RX240.JUSHA-C23C employs the maximum resolution values same as thatof RADIFORCE RX240. Comparison table of the principalcharacteristics of 2 devices is shown in the Attachment 1 |
| Attachment 1 | |
| The 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 the |
| JUSHA-C23C LCD Monitor to be as safe, as effective, and | |
| 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-C23C LCD Monitor device to the legally marketed predicate EIZO RADIFORCE RX240 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences | |
|---|---|---|---|---|
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | ||
| 510(k) Number | K113844 | |||
| Display Performance/Specifications | ||||
| Screentechnology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same | |
| Viewing angle(H, V) | Horizontal 176° ;Vertical176° | Horizontal 176° ;Vertical176° | Same | |
| Resolution | 1600 x 1200/1200 x 1600 | 1600 x 1200/1200 x 1600 | Same | |
| Display area | 432.0 (H) x 324.0(V) mm | 432.0 (H) x 324.0(V) mm | Same | |
| Contrast Ratio | 1200:1 | 1400:1 | Due to thedifferent panel. | |
| Scanningfrequency (H; V) | 31 | 52 | This differencebetween the twodevice is causedby the differentno display areadefined bydifferentmanufacturers,nothing to dowith the displayfunction. | |
| RecommendedLuminance | 400cd/m² | 400cd/m² | Same | |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm | Same. | |
| Backlight | LED | LED | Same | |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences | |
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | ||
| 510(k) Number | K113844 | / | ||
| DICOM LUT | 10-bit (Display Port) : 1024 | 12-bit:4096 | TheJUSHA-C23CLCD Monitoruses a grayscaleexpansiontechnology toimprove imagedisplay quality,the image clarityis better than theimage displayedon the predicatedevice. | |
| 8-bit: 256 | ||||
| Luminancecalibration | Built in calibration sensorprovided | Built in calibration sensorprovided | ||
| Video Signal Input | ||||
| Input signals | DVI standard 1.0, | DVI standard 1.0, | ||
| DisplayPort 1.1a | DisplayPort 1.1a | |||
| Inputterminational | DVI-D x 1, | DVI-D x 1, | ||
| DisplayPort x 1 | DisplayPort x 1 | |||
| Displaycontroller | Off the shelf | Off the shelf | ||
| Power Related Specification | ||||
| PowerRequirement | AC 100 | AC 100 | ||
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences | |
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | ||
| 510(k) Number | K113844 | / | ||
| PowerConsumption/Save Mode | 52W/less than1.6W | 65W/less than 2.5W | The differencescaused bydifferent adapterand componentsused in the LCDMonitor, theJUSHA-C23Chas more powerconsumption.This only showsthe powerconsumption isdifferent,nothing to dowith the displayfunction | |
| PowerManagement | DVI DMPMDisplayPort 1.1a | DVI DMPMDisplayPort 1.1a | Same | |
| Miscellaneous Features/Specifications | ||||
| USBPorts/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | Same | |
| Dimensions w/ostand(W x H x D) | Without stand:376mmx505mmx98mmWith stand:376mmx599mmx245.5 mm | Without stand:382mm x490mm x75mmWith stand:382mmx533mm x238mm | Differenthousing designdue to thedifferent panelsize. | |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences | |
| Product | RADIFORCE RX240 | JUSHA-C23C LCD Monitor | ||
| 510(k) Number | K113844 | / | ||
| Indication foruse | RADIFORCE RX240 isintended to be used indisplaying and viewingdigital images for diagnosisof X-ray or MRI, etc. bytrained medical practitioners.The device does notsupport the display ofmammography images fordiagnosis. | JUSHA-C23C LCD Monitoris intended to be used indisplaying and viewingdigital images for diagnosisof X-ray or MRI, etc. bytrained medical practitioners.The device does notsupport the display ofmammography images fordiagnosis. | Same | |
| Applicablestandard | 1 IEC 60601-1Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007)2 IEC 60601-1-2 Edition3:2007, Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests. | 1 IEC 60601-1Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007)2 IEC 60601-1-2 Edition3:2007, Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests. | 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-C23C 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-C23C 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-C23C, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C23C 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-C23C 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).