(39 days)
JUSHA-M33C LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
JUSHA-M33C LCD Monitor is the display system with the high resolution (2048*1536), high luminance (1000 cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 10 DICOM look up table and 3 GAMMA look up table inside. JUSHA-M33C 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, Mono-TFT LCD Panel
- JUSHA- 45T motherboard/FR-4/REV:0.9
- JUSHA-M33C 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.
The provided document is a 510(k) Premarket Notification for the JUSHA-M33C LCD Monitor. This document is for a medical display device, not an AI/ML powered device, therefore, many of the requested criteria related to AI/ML studies are not applicable.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, 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" in the way one might expect for a diagnostic AI model (e.g., sensitivity, specificity, AUC thresholds). Instead, the acceptance criteria for a medical display monitor are implicitly tied to demonstrating substantial equivalence to a legally marketed predicate device (EIZO GX340) by meeting relevant performance and safety standards.
The table below summarizes the key performance characteristics provided for the proposed device and its predicate. The "acceptance criteria" here are essentially the predicate device's specifications, which the proposed device aims to match or exceed to demonstrate substantial equivalence.
| Attribute | Acceptance Criteria (Predicate: EIZO GX340) | Reported Device Performance (JUSHA-M33C LCD Monitor) |
|---|---|---|
| Screen Technology | 21.3" Monochrome TFT LCD Panel | 21.3 inches, Mono-TFT LCD Panel |
| Viewing Angle (H, V) | Horizontal 176°, Vertical 176° | Horizontal 176°, Vertical 176° |
| Resolution | 2048 x 1536 / 1536 x 2048 | 2048 x 1536 / 1536 x 2048 |
| Display Area | 324.8 (H) x 433.1 (V) mm | 325.00 (H) x 433.00 (V) mm |
| Contrast Ratio | 1400:1 | 1400:1 |
| Scanning Freq (H; V) | 31 | 96.7 kHz; 60 Hz |
| Recommended Luminance | 500 cd/m² | 500 cd/m² |
| Pixel Pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm |
| Backlight | LED | LED |
| DICOM LUT | 10-bit (Display Port): 1024; 8-bit: 256 | 4096 |
| Luminance Calibration | Built in calibration sensor provided | Built in calibration sensor provided |
| Input Signals | DVI standard 1.0, DisplayPort 1.1a | DVI standard 1.0, DisplayPort 1.1a |
| Input Terminational | DVI-D (dual link) x 1, DisplayPort x 1 | DVI-D (dual link) x 1, DisplayPort x 1 |
| Display Controller | Off the shelf | Off the shelf |
| Power Requirement | AC 100 | AC 100 |
| Power Consumption/Save Mode | 36W / less than 1.6W | 45W / less than 3W |
| Power Management | DVI DMPM, DisplayPort 1.1a | DVI DMPM, DisplayPort 1.1a |
| USB Ports/Standard | 1 upstream (endpoint), 2 downstream / Rev. 2.0 | 1 upstream (endpoint), 2 downstream / Rev. 2.0 |
| Applicable Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 |
Study to Prove Acceptance Criteria:
The study proving the device meets the acceptance criteria is implicit within the "Determination of Substantial Equivalence" section. The document states:
- "The LCD Monitor complies with voluntary standards as following: IEC 60601-1... IEC 60601-1-2..." These indicate testing was performed to demonstrate compliance with these safety and essential performance standards.
- "JUSHA-M33C is substantially equivalent to EIZO GX340. JUSHA-M33C employs the maximum resolution values same as that of EIZO GX340. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1." The comparison table (reproduced above) is the primary "study" or evidence to support the claim of substantial equivalence based on technical specifications.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a hardware device (LCD monitor), not a software algorithm that processes medical images. The "test set" here refers to the device itself being tested against standards and compared to a predicate, not a dataset of patient images.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. Ground truth, in the context of image interpretation, is not established for a medical display device during its 510(k) submission. The performance of the monitor is assessed by technical specifications and compliance with standards, not by expert consensus on medical images displayed on it for the purpose of regulatory submission.
4. Adjudication Method for the Test Set
This is not applicable. As explained above, the "test set" and ground truth for image interpretation are not relevant for this hardware device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms in conjunction with human readers, which is not the subject of this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This device is an LCD monitor, not an algorithm. Its function is to display images for human interpretation, not to make diagnostic decisions independently.
7. The Type of Ground Truth Used
The "ground truth" for this medical device submission is the adherence to established technical specifications, industry standards (IEC 60601-1, IEC 60601-1-2), and the demonstrated equivalence to a predicate device's performance. It is not based on expert consensus on image interpretation, pathology, or outcomes data, as these relate to the content displayed, not the display hardware itself.
8. The Sample Size for the Training Set
This is not applicable, as this is a hardware device and does not involve AI/ML training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this hardware device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1, 2014
Nanjing Jusha Display Technology Co., Ltd. % Ms. Li Le Certification Manager 8A, Block 1, Nanjing International Service Outsourcing Mansion, No. 301 Hanzhongmen Street, Nanjing 210036 CHINA
Re: K141690
Trade/Device Name: Jusha-M33C LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 24, 2014 Received: June 30, 2014
Dear Ms. Le:
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,
Smh.7)
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K141690
Device Name
JUSHA-M33C LCD Monitor
Indications for Use (Describe)
JUSHA-M33C LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not specified for digital mammography system.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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., LtdAdd: 8A, Block 1. Nanjing International Service OutsourcingMansion, No. 301, Hanzhongmen street, Nanjing, China. |
| Contact Person: | Li leCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783271 |
| Device Trade Name: | JUSHA-M33C LCD Monitor |
| Common/Usual Name: | 3MP Monochrome LCD Monitor |
| Classification Name: ProductCode: | Display, Diagnostic Radiology 21CFR 892.2050PGY |
| Predicate Device(s): | EIZO GX340;K113784 |
| Device Description: | JUSHA-M33C LCD Monitor is the display system with the highresolution (2048*1536), high luminance (1000 cd/m²), and 1024simultaneous shades of gray out of a palette of 4096, 10 DICOM lookup table and 3 GAMMA look up table inside. JUSHA-M33C hasambient 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, Mono-TFT LCD Panel- JUSHA- 45T motherboard/FR-4/REV:0.9- JUSHA-M33C 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. |
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| Intended Use: | JUSHA-M33C 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 is not specified for digitalmammography system. | ||
|---|---|---|---|
| Technology: | JUSHA-M33C LCD Monitor is the display system with the highresolution monitor (3 megapixels) with electronic capabilities forevaluation of high resolution medical images, high luminance (1000cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096,10 DICOM look up table and 3 GAMMA look up table inside. Inparticular, JUSHA-M33C 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-M33C 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-M33C is substantially equivalent to EIZO GX340. JUSHA-M33C employs the maximum resolution values same as that of EIZOGX340. Comparison table of the principal characteristics of 2 devicesis shown in the 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 the JUSHA-M33C LCD Monitor to be as safe, as effective, and performance issubstantially equivalent to the predicate device(s). |
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510(k) Premarket Notification Submission
Attachment 1
| Attributes | Predicate Device | Proposed Device |
|---|---|---|
| Product | EIZO GX340 | JUSHA-M33C LCD Monitor |
| 510(k) Number | K113784 | K141690 |
| Screen technology | 21.3" Monochrome TFT LCDPanel | 21.3inches, Mono-TFT LCD Panel |
| Viewing angle (H, V) | Horizontal 176°,Vertical 176° | Horizontal 176°,Vertical 176° |
| Resolution | 2048 x 1536/1536x 2048 | 2048 x1536/1536x 2048 |
| Display area | 324.8 (H) x 433.1 (V) mm | 325.00 (H) x 433.00 (V) mm |
| Contrast Ratio | 1400:1 | 1400:1 |
| Scanning frequency (H; V) | 31 | 96.7kHz;60Hz |
| RecommendedLuminance | 500cd/m² | 500cd/m² |
| Pixel Pitch | 0.2115x0.2115 mm | 0.2115x0.2115 mm |
| Backlight | LED | LED |
| DICOM LUT | 10-bit (Display Port) : 10248-bit: 256 | 4096 |
| Luminance calibration | Built in calibration sensor provided | Built in calibration sensor provided |
| Input signals | DVI standard 1.0,DisplayPort 1.1a | DVI standard 1.0,DisplayPort 1.1a |
| Input terminational | DVI-D (dual link) x 1, DisplayPort x 1 | DVI-D (dual link) x 1, DisplayPort x 1 |
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| 510(k) Premarket Notification Submission | |||||
|---|---|---|---|---|---|
| Display controller | Off the shelf | Off the shelf |
|---|---|---|
| Power Requirement | AC 100 | AC 100 |
| PowerConsumption/SaveMode | 36W/less than1.6W | 45W/less than 3W |
| Power Management | DVI DMPMDisplayPort 1.1a | DVI DMPMDisplayPort 1.1a |
| USB Ports/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 |
| Dimensions w/o stand(W x H x D) | Without stand:376mmx505mmx98mmWith stand:376mmx599mmx245.5 mm | Without stand:382mm x490mm x75mm With stand:382mm x533mm x238mm |
| Applicable standard | 1 IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 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 essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | 1 IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 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 essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. |
§ 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).