(56 days)
JUSHA-C43 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
JUSHA-C43 LCD Monitoris the display system with the high resolution(2560 x 1600), high luminance(350cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096, 4 DICOM look up table inside, the product is consisted of the following components:
- 30inch, Color Active Matrix Liquid Crystal Display
- FR4-v0.4
- JUSHA-C43 LCD Monitor software
- Power Adapter
- Data Cable.
The LCD Monitoris 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.
The provided document describes the JUSHA-C43 LCD Monitor, a display system for medical imaging review and analysis. The submission focuses on demonstrating substantial equivalence to a predicate device (RADIFORCE RX440; K130070) through bench testing for display performance and adherence to electrical safety and electromagnetic compatibility (EMC) standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding pass/fail results or reported device performance against specific numerical targets. Instead, it lists the types of measurements performed in bench testing and states that the device "meets all performance standards" without providing the specific standards or numerical outcomes.
However, based on the Discussion of Differences in the comparison table, we can infer some implied performance expectations and how the JUSHA-C43 LCD Monitor performs relative to its predicate.
| Acceptance Criteria (Inferred from Predicate Comparison & Bench Testing) | Reported Device Performance (JUSHA-C43 LCD Monitor) |
|---|---|
| Display Performance | |
| Screen Technology Performance (Resolution, Luminance, Viewing Angle) | Resolution: 2560 x 1600 / 1280 x 1600 x 2 (Same as predicate) |
| Recommended Luminance: 300cd/m² (Same as predicate) | |
| Viewing Angle: Horizontal 178°, Vertical 178° (Wider than predicate) | |
| Contrast Ratio: 1200:1 (Higher than predicate, "can display image more clarity") | |
| Display Area: 641.28 (H) x 400.8 (V) mm (Same as predicate) | |
| Pixel Pitch: 0.2505 x 0.2505 mm (Same as predicate) | |
| Angular Dependency of Luminance Response | Measurement performed, device "meets all performance standards." (No specific results provided) |
| Luminance Non-uniformity characteristics (TG18 guideline) | Measurement performed, device "meets all performance standards." (No specific results provided) |
| Chromaticity Non-uniformity characteristics (TG18 guideline) | Measurement performed, device "meets all performance standards." (No specific results provided) |
| Small-spot Contrast Ratio | Measurement performed, device "meets all performance standards." (No specific results provided) |
| Temporal Response | Measurement performed, device "meets all performance standards." (No specific results provided) |
| Luminance Stability | Measurement performed, device "meets all performance standards." (No specific results provided) |
| Display Colors | 12-bit, 68.7 billion colors (Better than predicate, uses "color extension technology to improve image display quality") |
| Scanning Frequency (H; V) | 103.8kHz; 50Hz (Different from predicate, but display area and effect are stated to be "same") |
| Dot Clock | 148MHz (Different from predicate, but display area and effect are stated to be "same") |
| Electrical Safety and EMC | |
| IEC 60601-1 (Safety) | Complies with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) (Newer edition than predicate) |
| IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 Edition 3:2007 (Same edition as predicate) |
| Other | |
| Power Consumptions/Save Mode | 82W (less than predicate's 84W); less than 1.5W in save mode (different but not affecting display function) |
| Indications for Use | Same as predicate: displaying digital images for review and analysis by trained medical practitioners; does not support mammography. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes bench testing only. There is no mention of a test set involving medical images or patient data, nor is there any information about sample size for such a test set, country of origin, or whether it was retrospective or prospective. The testing was performed on the device itself.
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)
Not applicable. Since there was no test set involving medical images or human interpretation, there were no experts used to establish ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set involving human interpretation was performed.
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 an LCD monitor, not an AI-powered diagnostic tool. No MRMC study was conducted, and the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance relies on engineering specifications and established international standards. For example, luminance and chromaticity non-uniformity were measured against TG18 guidelines, and electrical safety and EMC were evaluated against IEC 60601-1 and IEC 60601-1-2 standards.
8. The sample size for the training set
Not applicable. This device is a hardware display monitor; it does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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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: K151972
Trade/Device Name: JUSHA-C43 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 16, 2015 Received: July 16, 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 Ochs
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) K151972
Device Name JUSHA-C43 LCD Monitor
Indications for Use (Describe)
JUSHA-C43 LCD Monitor is intended to be used in displaying digital images for review and analysis by trained medical practitioners. It does not support the display of mammography images for diagnosis.
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: | Jun,15,2015 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., LtdAdd: 301, Hanzhongmen Street, 8F Block A, No.1, NanjingInternational Service Outsourcing Mansion, Nanjing, 210036 China |
| Contact Person: | Ma JingCertification EngineerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783271 |
| Device Trade Name: | JUSHA-C43 LCD Monitor |
| Common/Usual Name: | 4MP Color LCD Monitor |
| Classification Name: | System, image processing ,Radiology |
| Product Code: | PGY |
| Predicate Device(s): | RADIFORCE RX440;K130070 |
| Device Description: | JUSHA-C43 LCD Monitoris the display system with the highresolution(2560 x 1600), high luminance(350cd/m²) and 1024simultaneous shades of gray out of a palette of 4096, 4 DICOMlook up table inside, the product is consisted of the followingcomponents:- 30inch, Color Active Matrix Liquid Crystal Display- FR4-v0.4 |
| - JUSHA-C43 LCD Monitor software- Power Adapter- Data Cable.The LCD Monitoris designed, tested, and will be manufacturedin accordance with both mandatory and voluntary standards:1. IEC 60601-1Medical equipment medical electricalequipment - Part 1: General requirements for basicsafety and essential performance 2005 + CORR. 1(2006) +CORR. 2 (2007)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-C43 LCD Monitoris intended to be used in displayingand viewing digital images for review and analysis by trainedmedical practitioners. It does not support the display ofmammography images for diagnosis. |
| Technology: | JUSHA-C43 LCD Monitor is the display system with the highresolution monitor (4 megapixels) with electronic capabilities forevaluation of high resolution medical images, highluminance(350cd/m²) and 1024 simultaneous shades of grayout of a palette of 4096, 4 DICOM look up table inside |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests:The LCD Monitor complies with voluntary standards asfollowing:1 IEC 60601-1Medical equipment medical electrical |
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| require clinical studies to support substantial equivalence.The proposed device is Substantially Equivalent (SE) to thepredicate 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 theJUSHA-C43 LCD Monitor to be as safe as effective, andperformance is substantially equivalent to the predicatedevice(s). |
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This comparison identifies the similarities and differences of the proposed JUSHA-C43 LCD Monitor device to the legally marketed predicate EIZO RADIFORCE RX440 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Display Performance/Specifications | |||
| Screentechnology | 29.8" Color TFT LCDPanel | 30", Color Active MatrixTFT LCD Panel | The panel ofJUSHA-C43 is largerthan the predicatedevice, it can displaymoreinformation |
| Viewing angle(H, V) | Horizontal 176°,Vertical176° | Horizontal 178°,Vertical178°(CR > 10) | The viewing angle ofJUSHA-C43 is widerthan the predicatedevice, it can getgreater field of view |
| Resolution | 2560 x1600/1280 x1600x2 | 2560 x 1600/1280 x 1600x2 | Same |
| Display area | 641.2(H) x 400.8 (V) mm | 641.28 (H) x 400.8 (V) mm | Same |
| RecommendedLuminance | 300cd/m² | 300cd/m² | Same |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Contrast Ratio | 1100:1 | 1200:1 | The contrast ratio ofJUSHA-C43 is higherthan the predicatedevice, it can displayimage more clarity |
| Scanningfrequency (H; V) | 31 - 159 kHz / 29 - 61 Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 59 - 61 Hz, 29.5 -30.5 Hz | 103.8kHz;50Hz | The two differencesbetween the twodevice is caused bythe different nodisplay area definedby differentmanufacturers, butthe display area issame(2048*2560),sothe same picturedisplayed on the twodevices has the sameeffect |
| Dot clock | 152MHz | 148MHz | by differentmanufacturers, butthe display area issame(2048*2560),sothe same picturedisplayed on the twodevices has the sameeffect |
| Pixel Pitch | 0.2505 x 0.2505 mm | 0.2505 x 0.2505 mm | Same |
| Backlighting | LED | LED | Same |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Display Colors | 10-bit, 1.07 billion colors | 12-bit , 68.7billion colors | The JUSHA-C43 LCDMonitor uses a colorextension technologyto improve imagedisplay quality |
| Luminancecalibration | Built in calibration sensorprovided | Built in calibration sensorprovided | Same |
| Video Signal Input | |||
| Input signals | DVI standard 1.0 | DVI standard 1.0 | Same |
| Inputterminational | DVI-D (dual link) x 1,DVI-D (single link) x 1,DisplayPort x 1 | DVI-D (dual link) x 1,DVI-D (single link) x 1,DisplayPort x 1 | Same |
| Displaycontroller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| PowerRequirement | AC 100 - 120 V, 200 - 240V: 50 / 60 Hz | AC 100-240V 50-60Hz | same |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| PowerConsumptions/Save Mode | 84W/less than 0.7W | 82W/less than1.5W | The differencescaused by differentadapter andcomponents used inthe LCD Monitor, theJUSHA-C43 hasfewer powerconsumptions, thisonly shows the powerconsumption isdifferent, nothing todo with the displayfunction |
| PowerManagement | DVI DMPM, DisplayPort1.1a | DVI DMPM, DisplayPort1.1a | Same |
| Miscellaneous Features/Specifications | |||
| USBPorts/standard | 1 upstream ,2 downstream/ Rev. 2.0 | 1 upstream (endpoint), 2downstream/ Rev. 2.0 | Same |
| Dimensions w/ostand(W x H x D) | Without stand:702x108x473 mm | With stand:692x252x523mmWithout stand:692x87x453mm | Different housingdesign due to thedifferent panel size. |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Indication for use | RADIFORCE RX440 isintended to be used indisplaying and viewingdigital images for reviewand analysis by trainedmedical practitioners. Itdoes not support thedisplay of mammographyimages for diagnosis. | JUSHA-C43 LCD Monitoris intended to be used indisplaying and viewingdigital images for reviewand analysis by trainedmedical practitioners. Itdoes not support thedisplay of mammographyimages for diagnosis. | Same |
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| Attributes | Predicate Device | Proposed Device | Discussion of Differences |
|---|---|---|---|
| Product | RADIFORCE RX440 | JUSHA-C43 LCD Monitor | |
| 510(k) Number | K130070 | / | |
| Applicablestandard | 1 IEC 60601-1Medicalequipment medicalelectrical equipment - Part1: General requirementsfor basic safety andessential performance1988+A1 : 1991 +A2:19952 IEC 60601-1-2 Edition3:2007, Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility -Requirements and tests. | 1 IEC 60601-1Medicalequipment medicalelectrical equipment - Part1: General requirementsfor basic safety andessential performanceIEC 60601-1:2005 +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 -Requirements and tests. | The JUSHA-C43safety standard isedition 3.0,RADIFORCE RX440safety standard isedition 2.0. nothing todo with the displayfunction |
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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-C43 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-C43. 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-C43, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C43 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-C43 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).