(252 days)
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is intended 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 specially designed for displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is the display system with the high resolution (4200x2800), high luminance (800 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA- C1210G has ambient brightness adapt inside. In particular, JUSHA- C1210G 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:
- 31" Color-TFT LCD Panel
- DMF2604AR0/main board/REV1.0
- JUSHA-C1210G LCD Monitor software
- Power Adapter
- Data Cable.
Here's a breakdown of the acceptance criteria and the study information for the JUSHA-C1210G LCD Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" with corresponding reported device performance values in a direct, comparative format. Instead, it describes various performance evaluations that were conducted and states that the device "meets all performance standards" and "complies with" certain industry standards.
The acceptance criteria are implicitly defined by the standards and performance measurements listed under "Bench testing" and "Electrical safety and electromagnetic compatibility (EMC)". The reported device performance is indicated by the general statement of compliance.
Therefore, the table below is constructed by inferring the acceptance criteria from the tests mentioned and noting the general statement of compliance as the "reported device performance."
| Acceptance Criteria (Implicit from Tests) | Reported Device Performance (General Statement) |
|---|---|
| Measurement of angular dependency of luminance response | Meets all performance standards |
| Measurement of luminance non-uniformity characteristics (TG18) | Meets all performance standards |
| Measurement of chromaticity non-uniformity characteristics (TG18) | Meets all performance standards |
| Measurement of small-spot contrast ratio | Meets all performance standards |
| Measurement of temporal response | Meets all performance standards |
| Performance data on luminance stability | Meets all performance standards |
| Electrical safety (IEC 60601-1) | Complies with IEC 60601-1 |
| Electromagnetic compatibility (EMC) (IEC 60601-1-2) | Complies with IEC 60601-1-2 |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes "bench testing" of the LCD monitor. For a display device, the "test set" would typically refer to the specific unit(s) of the device being evaluated. However, the document does not specify the sample size (number of units) used for these bench tests.
The data provenance is also not explicitly stated. It's generally inferred that bench testing is conducted by the manufacturer (Nanjing Jusha Display Technology Co., Ltd. in China), but specific country of origin for the test data, or whether it's retrospective or prospective testing, is not detailed. Given it's a premarket submission, the testing would be prospective for the device seeking clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and therefore not provided in the document. The device is an LCD monitor, a hardware display system, not an AI algorithm or diagnostic tool that requires expert-established ground truth for its performance evaluation (e.g., image interpretation). Its performance is assessed through objective physical and electrical measurements.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations are objective technical measurements of a hardware device's performance against established standards, not subjective interpretations requiring adjudication.
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 comparative effectiveness study was not done. This type of study is relevant for AI algorithms in medical image analysis, not for a standalone hardware display monitor. The document explicitly states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was done, in the sense that the device's performance was assessed purely on its technical specifications and compliance with standards, without direct human interaction as part of the performance measurement itself. This is what "bench testing" and "electrical safety and EMC" evaluations represent for a display monitor. There is no "algorithm" in the context of an AI device, but rather the intrinsic performance of the display hardware.
7. The Type of Ground Truth Used
For a medical display monitor, the "ground truth" for its performance is typically defined by:
- Industry standards and specifications: Such as those from AAPM (American Association of Physicists in Medicine) or DICOM (Digital Imaging and Communications in Medicine) for display characteristics. The document mentions compliance with "TG18 guideline" (likely AAPM TG18 for display quality control) and "DICOM standard LUT."
- International safety and EMC standards: Specifically IEC 60601-1 and IEC 60601-1-2.
These standards and guidelines serve as the objective "ground truth" against which the monitor's physical, photometric, and electrical properties are measured and evaluated for compliance.
8. The Sample Size for the Training Set
This information is not applicable. The device is an LCD monitor, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI algorithm requiring a training set with ground truth.
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Nanjing Jusha Display Technology Co., Ltd. % Donny Lee Certification Engineer 8A, Block 1. No. 301, Hanzhongmen Street Nanjing, Jiangsu 210036 CHINA
March 25, 2022
Re: K212231
Trade/Device Name: C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: January 24, 2022 Received: January 24, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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 (QS) 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 medical devices and radiation-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 Mammography Ultrasound and Imaging Software Branch 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) K212231
Device Name C1210G/JUSHA-C1210G/C1210/JUSHA-C1210 LCD Monitor
Indications for Use (Describe)
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is intended 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 specially designed for displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, 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 CER 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CER 801 Subpart C) |
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K212231
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 26, 2021 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Contact Person: | Add: 301, 8F Block A, No.1, Nanjing International ServiceOutsourcing Mansion, Hanzhongmen Street,Nanjing, 210036 ChinaDongdong LiCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783273 |
| Device Trade Name: | JUSHA-C1210G LCD Monitor, JUSHA-C1210 LCD Monitor,C1210G LCD Monitor, C1210 LCD Monitor |
| Common/Usual Name: | 12MP Color LCD Monitor |
| Classification Name: | System, image processing, Radiological 21CFR 892.2050PGY |
| Product Code: | |
| Predicate Device(s): | JUSHA JUSHA-M550G; K190848 |
| Device Description: | JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is thedisplay system with the high resolution (4200×2800), highluminance (800 cd/m²), and 16-bit grayscale (65536 level), built-inDICOM standard LUT. In particular, JUSHA- C1210G has ambientbrightness adapt inside. In particular, JUSHA- C1210G has ambientbrightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization 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:- 31" Color-TFT LCD Panel- DMF2604AR0/main board/REV1.0- JUSHA-C1210G LCD Monitor software- Power Adapter |
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| - 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-C1210G/JUSHA-C1210/C1210G/C1210 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 speciallydesigned for displaying and viewing digital images, includingstandard and multi-frame digital mammography, for review, analysis,and diagnosis by trained medical practitioners. It is specially designedfor breast tomosynthesis applications. | ||
| Technology: | JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is thedisplay system with the high resolution ( $4200\times2800$ ), highluminance (800 cd/m²), and 16-bit grayscale (65536 level), built-inDICOM standard LUT. In particular, JUSHA- C1210G has ambientbrightness adapt inside. In particular, JUSHA- C1210G has ambientbrightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, withthese this display can automatic adjustment according to differentrequirements in 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/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. |
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| 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 essentialperformance - Collateral standard: Electromagnetic disturbances -Requirements and tests |
|---|---|
| JUSHA-C1210G is substantially equivalent to JUSHA JUSHA-M550G. JUSHA-C1210G employs the maximum resolution valueslarger than that of JUSHA-M550G. Comparison table of the principalcharacteristics of 2 devices is shown in the Product Comparison. | |
| 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 the JUSHA-C1210G LCD Monitor to be as safe, as effective, and performance is |
12.1 Product Comparison
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This comparison identifies the similarities and differences of the proposed JUSHA-C1210G LCD Monitor device to the legally marketed predicate JUSHA JUSHA-M550G LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCDMonitor | |
| 510(k) Number | K190848 | / | |
| Display Performance/Specifications | |||
| Screentechnology | 21.3inches, Mono-TFT LCDPanel | 31inches, Color-TFT LCDPanel | C1210G is largerthan M550G |
| Viewing angle(H, V) | Horizontal 170°,Vertical170° | Horizontal 178°,Vertical178° | C1210G is betterthan M550G |
| Resolution | $2560 \times 2048/2048 \times 2560$ | $4200\times2800$ | C1210G is largerthan M550G |
| Display area | $422.4(H)\times377.92(V)$ mm | $676.9(H)\times459.7(V)$ mm | C1210G is largerthan M550G |
| Contrast Ratio | 1700:1 | 1500:1 | C1210G issmaller thanM550G, but thedifference doesnot makedifference to thediagnosis. |
| SuppliedCURVE | DICOM\CIE\GAMMA2.2\GAMMA2.4 | DICOM\CIE\GAMMA2.2\GAMMA2.4 | Same |
| DICOMcalibratedluminance | 1000cd/m² | 800cd/m² | C1210G issmaller thanM550G, andboth of themmeet therequirements ofAAPMregarding breastdiagnosis. |
| Pixel Pitch | $0.165\times0.165$ mm | $0.1554\times0.1554$ mm | C1210G is betterthan M550G |
| Backlight | LED | LED | Same. |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | Same. |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCDMonitor | |
| 510(k) Number | K190848 | / | |
| Luminancecalibration | Built in calibration sensorprovided | Built in calibration sensorprovided | Same |
| Video Signal Input | |||
| Input signals | DVI standard 1.0,DisplayPort 1.2a | DisplayPort 1.2a | The differenceonly shows thatthey havedifferentinput,has nothingto do with thedisplay function. |
| Inputterminational | DVI-D×1,DisplayPort×1 | DisplayPort×2 | The differenceonly shows thatthey havedifferentinput,has nothingto do with thedisplay function. |
| Output signals | DisplayPort 1.2a | HDMI 2.0 | The differenceonly shows thatthey havedifferent output,has nothing to dowith the displayfunction. |
| OutputTerminational | DisplayPort×1 | HDMI×1 | The differenceonly shows thatthey havedifferent output,has nothing to dowith the displayfunction. |
| Displaycontroller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| PowerRequirement | AC 100 | AC 100 | Same |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCDMonitor | |
| 510(k) Number | K190848 | / | |
| PowerConsumption/Save Mode | 55W/less than 0.5W | 150W/less than 0.5W | The differencescaused bycomponents usedin the LCDMonitor. Thisonly shows thepowerconsumption isdifferent,nothing to dowith the displayfunction |
| PowerManagement | DVI DMPMDisplayPort 1.2a | DisplayPort 1.2a | The differenceonly shows thatthey havedifferent powerManagement,has nothing to dowith the displayfunction. |
| Miscellaneous Features/Specifications | |||
| USBPorts/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 3.0 | C1210G is betterthan M550G. |
| Dimensions w/ostand(W×H×D) | Without stand:$363mm×475mm×66mm$With stand:$363mm×635mm×238mm$ | Without stand:$701.3 mm× 500 mm×$86.8mmWith stand:$701.3 mm× 589 mm×$245mm | Differenthousing designdue to thedifferent panelsize. |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCDMonitor | |
| 510(k) Number | K190848 | / | |
| Indication foruse | 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. | JUSHA-C1210G/JUSHA-C1210/ C1210G/ C1210LCD Monitor is intended tobe used 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 |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | JUSHA JUSHA-M550G | JUSHA-C1210G LCDMonitor | |
| 510(k) Number | K190848 | / | |
| 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:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticdisturbances - Requirementsand tests | 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 |
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-C1210G 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. ●
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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-C1210G 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-C1210G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-C1210G Medical Display is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The nonclinical 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-C1210G 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).