(43 days)
JUSHA-M550G/JUSHA-M550/M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA-M550G has ambient brightness adapt inside. In particular, JUSHA-M550G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization 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: - 21.3" Mono-TFT LCD Panel - DMX0704AR0/main board/REV1.1 - JUSHA-M550G LCD Monitor software - Power Adapter - Data Cable
The document describes the JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor, intended for displaying and viewing digital images, including standard and multi-frame digital mammography and breast tomosynthesis applications.
Here's an analysis of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state numerical acceptance criteria in a table format but outlines the performance tests conducted, implying that the device met acceptable standards for these tests. The comparison to the predicate device (BARCO MDMG-5221; K161229) is a key aspect of demonstrating substantial equivalence.
| Acceptance Criteria (Implied from Bench Testing) | Reported Device Performance (JUSHA-M550G/M550) |
|---|---|
| Angular dependency of luminance response | Met, as bench testing was conducted |
| Luminance non-uniformity characteristics (TG18 guideline) | Met, as bench testing was conducted |
| Chromaticity non-uniformity characteristics (TG18 guideline) | Met, as bench testing was conducted |
| Small-spot contrast ratio | Met, as bench testing was conducted |
| Temporal response | Met, as bench testing was conducted |
| Luminance stability | Met, as performance data was provided |
| Electrical safety (IEC 60601-1) | Complies with IEC 60601-1 standard |
| Electromagnetic compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2 standard |
Comparison to Predicate Device (BARCO MDMG-5221):
| Attribute | Predicate Device Performance | Proposed Device Performance | Discussion of Differences (from document) |
|---|---|---|---|
| Screen technology | 21.3 inches, Mono-TFT LCD Panel | 21.3 inches, Mono-TFT LCD Panel | Same |
| Resolution | 2560 x 2048 / 2048 x 2560 | 2560 x 2048 / 2048 x 2560 | Same |
| DICOM calibrated luminance | 1000 cd/m2 | 1000 cd/m2 | Same |
| Pixel Pitch | 0.165 x 0.165 mm | 0.165 x 0.165 mm | Same |
| Backlight | LED | LED | Same |
| DICOM LUT | 10-bit: 1024 | 16-bit: 65536 | The JUSHA-M550G LCD Monitor uses a color bit expansion technology to improve image display quality, the image clarity is better than the image displayed on the predicate device. |
| Luminance calibration | Built-in calibration sensor provided | Built-in calibration sensor provided | Same |
| Input signals | DVI standard 1.0, DisplayPort 1.2a | DVI standard 1.0, DisplayPort 1.2a | Same |
| Input terminational | DVI-D x 1, DisplayPort x 1 | DVI-D x 1, DisplayPort x 1 | Same |
| Display controller | Off the shelf | Off the shelf | Same |
| Power Requirement | AC 100 | AC 100 | Same |
| Power Consumption/Save Mode | 57W / less than 0.7W | 55W / less than 0.5W | The differences caused by components used in the LCD Monitor. This only shows the power consumption is different, nothing to do with the display function. |
| Power Management | DVI DMPM, DisplayPort 1.2a | DVI DMPM, DisplayPort 1.2a | Same |
| USB Ports/standard | 1 upstream (endpoint), 2 downstream / Rev. 2.0 | 1 upstream (endpoint), 2 downstream / Rev. 2.0 | Same |
| Indication for use | Same as proposed device | Same as predicate device | Same |
2. Sample size used for the test set and the data provenance
The document states that bench testing was conducted. For device performance testing of this nature (LCD monitor characteristics), the "sample size" typically refers to the number of units tested. However, this specific number is not explicitly mentioned in the provided text.
The data provenance is implied to be from the manufacturer's internal testing facilities (Nanjing Jusha Display Technology Co., Ltd) and is retrospective in the sense that the results were submitted for regulatory review after the tests were completed. There is no information about the country of origin of the data itself in terms of medical images or patient information, as this device is a display monitor and not an AI algorithm processing medical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device. The JUSHA-M550G/M550 is an LCD monitor for displaying images, not a diagnostic or interpretive AI algorithm. Therefore, there is no "ground truth" to be established by medical experts for its performance, beyond ensuring it accurately and consistently displays existing medical images. The performance is assessed against technical specifications and conformity to standards like TG18.
4. Adjudication method for the test set
Not applicable. As explained above, for an LCD monitor's performance testing, there is no "ground truth" to be adjudicated in the sense of a medical diagnosis. The performance is evaluated based on objective technical 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
Not applicable. This device is an LCD display monitor, not an AI-powered diagnostic tool. Therefore, MRMC studies evaluating human reader performance with or without AI assistance are not relevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an LCD display monitor, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. As explained in point 3, the concept of "ground truth" for medical diagnosis does not apply to the technical performance evaluation of an LCD display monitor. The "ground truth" for the device's technical specifications is established by predefined industry standards and measurements (e.g., DICOM standard, TG18 guideline).
8. The sample size for the training set
Not applicable. This device is an LCD display monitor and does not involve machine learning or AI algorithms that require a "training set."
9. How the ground truth for the training set was established
Not applicable. As explained in point 8, there is no training set for this device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Nanjing Jusha Display Technology Co., Ltd % Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, Jiangsu 210036 CHINA
Re: K190848
Trade/Device Name: JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: Class II Product Code: PGY Dated: April 10, 2019 Received: April 10, 2019
Dear Zilong Liang:
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.
May 14, 2019
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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K190848
Device Name
JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor
Indications for Use (Describe)
JUSHA-M550G/JUSHA-M550/M550 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
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: | February 26, 2019 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Add: 301, 8F Block A, No.1, Nanjing International ServiceOutsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 China | |
| Contact Person: | Zilong LiangCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783273 |
| Device Trade Name: | JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor |
| Common/Usual Name: | 5MP Color LCD Monitor |
| Classification Name: | System, image processing, Radiological 21CFR 892.2050PGY |
| Product Code: | |
| Predicate Device(s): | BARCO MDMG-5221; K161229 |
| Device Description: | JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor is thedisplay system with the high resolution (2560*2048), high luminance(1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOMstandard LUT. In particular, JUSHA-M550G has ambient brightnessadapt inside. In particular, JUSHA-M550G has ambient brightnessadapting, real-time DICOM automatic calibration, full-screenbrightness equalization and presence induction system, with these thisdisplay can automatic adjustment according to different requirementsin order to achieve the best results.The product is consisted of the following components:- 21.3" Mono-TFT LCD Panel- DMX0704AR0/main board/REV1.1- JUSHA-M550G 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,CFR 47 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-M550G/JUSHA-M550/M550G/M550 LCD Monitor isintended to be used in displaying and viewing digital images,including standard and multi-frame digital mammography, for review,analysis, and diagnosis by trained medical practitioners. It is speciallyde displaying and viewing digital images, including standard andmulti-frame digital mammography, for review, analysis, and diagnosisby trained medical practitioners. It is specially designed for breasttomosynthesis applications. |
| Technology: | JUSHA-M550G/JUSHA-M550/M550G/M550 LCD Monitor is thedisplay system with the high resolution (2560*2048), high luminance(1000 cd/m2), and 16-bit grayscale (65536 level), built-in DICOMstandard LUT. In particular, JUSHA-M550G has ambient brightnessadapt inside. In particular, JUSHA-M550G has ambient brightnessadapting, real-time DICOM automatic calibration, full-screenbrightness equalization and presence induction system, with these thisdisplay can automatic adjustment according to different requirementsin order 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/AAMIES60601-1:2005+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 47FCC Part15 subpart B: 2017, Medical electrical equipment - Part1-2: General requirements for basic safety and essential | |
| Requirements and tests | |
| JUSHA-M550G is substantially equivalent to BARCO MDMG-5221.JUSHA-M550G employs the maximum resolution values same as thatof BARCO MDMG-5221. Comparison table of the principalcharacteristics of 2 devices is shown in the Attachment 1. | |
| Attachment 1 | |
| The following quality assurance measures were applied to thedevelopment 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 notrequire clinical studies to support substantial equivalence.The proposed device is Substantially Equivalent (SE) to the predicatedevice which is US legally market device. Therefore, the subjectdevice is determined as safe and effectiveness. | |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers theJUSHA-M550G LCD Monitor to be as safe, as effective, andperformance is substantially equivalent to the predicate device(s) |
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This comparison identifies the similarities and differences of the proposed JUSHA-M550G LCD Monitor device to the legally marketed predicate BARCO MDMG-5221 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | BARCO MDMG-5221 | JUSHA-M550G LCDMonitor | |
| 510(k) Number | K161229 | / | |
| Display Performance/Specifications | |||
| Screentechnology | 21.3inches, Mono-TFT LCDPanel | 21.3inches, Mono-TFT LCDPanel | Same |
| Viewing angle(H, V) | Horizontal 176°,Vertical176° | Horizontal 170°, Vertical170° | - |
| Resolution | 2560 x 2048/2048x 2560 | 2560 x2048/2048x 2560 | Same |
| Display area | 422.4(H) x 377.9 (V) mm | 422.4(H) x377.92(V) mm | - |
| Contrast Ratio | 950:1 | 1700:1 | - |
| DICOMcalibratedluminance | 1000cd/m2 | 1000cd/m2 | Same |
| Pixel Pitch | 0.165x0.165 mm | 0.165x0.165 mm | Same |
| Backlight | LED | LED | Same. |
| DICOM LUT | 10-bit:1024 | 16-bit:65536 | TheJUSHA-M550GLCD Monitoruses a color bitexpansiontechnology toimprove imagedisplay quality,the image clarityis better than theimage displayedon the predicatedevice. |
| Luminancecalibration | Built in calibration sensorprovided | Built in calibration sensorprovided | Same |
| Video Signal Input | |||
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | BARCO MDMG-5221 | JUSHA-M550G LCDMonitor | |
| 510(k) Number | K161229 | / | |
| Input signals | DVI standard 1.0,DisplayPort 1.2a | DVI standard 1.0,DisplayPort 1.2a | Same |
| Inputterminational | DVI-D x 1,DisplayPort x 1 | DVI-D x 1,DisplayPort x 1 | Same |
| Output signals | - | DisplayPort 1.2a | - |
| Output | - | DisplayPort x 1 | - |
| Terminational | |||
| Displaycontroller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| PowerRequirement | AC 100 | AC 100 | Same |
| PowerConsumption/Save Mode | 57W/less than 0.7W | 55W/less than 0.5W | The differencescaused bycomponents usedin the LCDMonitor. Thisonly shows thepowerconsumption isdifferent,nothing to dowith the displayfunction |
| PowerManagement | DVI DMPMDisplayPort 1.2a | DVI DMPMDisplayPort 1.2a | Same |
| Miscellaneous Features/Specifications | |||
| USBPorts/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | Same |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | BARCO MDMG-5221 | JUSHA-M550G LCD Monitor | |
| 510(k) Number | K161229 | / | |
| Dimensions w/ostand(W x H x D) | Without stand:392mm x484mm x122mmWith stand:780mm x550mm x261mm | Without stand:363mm x475mm x66mmWith stand:363mm x635mm x238mm | Differenthousing designdue to thedifferent panelsize. |
| Indication foruse | BARCO MDMG-5221device intended to be used indisplaying and viewingdigital images, includingstandard and multi-framedigital mammography, forreview, analysis, anddiagnosis by trained medicalpractitioners. It is speciallyde displaying and viewingdigital images, includingstandard and multi-framedigital mammography, forreview, analysis, anddiagnosis by trained medicalpractitioners. It is speciallydesigned for breasttomosynthesis applications. | JUSHA-M550G/JUSHA-M550/M550G/M550 LCDMonitor is intended to beused in displaying andviewing digital images,including standard andmulti-frame digitalmammography, for review,analysis, and diagnosis bytrained medical practitioners.It is specially de displayingand viewing digital images,including standard andmulti-frame digitalmammography, for review,analysis, and diagnosis bytrained medical practitioners.It is specially designed forbreast tomosynthesisapplications. | Same |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | BARCO MDMG-5221 | JUSHA-M550G LCDMonitor | |
| 510(k) Number | K161229 | / | |
| Applicablestandard | Electrical Safety test (IEC60601-1)EMC test (IEC 60601-1-2) | 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:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticdisturbances - 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-M550G 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. .
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- 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-M550G 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-M550G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-M550G 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. The device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-M550G 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).