(85 days)
C660G/C810G LCD Monitor is intended to be used in displaying digital images diagnosis of X-ray or MRI.etc.by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
JUSHA-C660G/JUSHA-C660/C660G/C660 LCD Monitor is the display system with high resolution (3280×2048), high luminance (800 cd/m2), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, C660G has ambient brightness adaptation inside, on top of which C660G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results.
The product is consisted of the following components:
- the display with stand
- a graphic card
- agraphic card driver CD
- an AC power cable
- an external power supply
- a Type-C cable
- Three DP cables
- a USB cable
JUSHA-C810G/ C810G LCD Monitor is the display system with high resolution (3840×2160), high luminance (800 cd/m2), and 14-bit grayscale (16384 grayscale), built-in DICOM standard LUT. In particular, C810G has ambient brightness adaptation inside, on top of which C810G has real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results.
The product is consisted of the following components:
- the display with stand
- a graphic card
- agraphic card driver CD
- an AC power cable
- an external power supply
- a DVI cable
- two Mini DP switch to DP cable
- a USB cable
The LCD Monitors are designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
- IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
The provided document describes the FDA 510(k) premarket notification for the JUSHA-C810G/C810G LCD Monitor and JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor. These are medical image display systems.
The acceptance criteria for this device are based on its performance specifications and compliance with recognized standards, demonstrating substantial equivalence to a legally marketed predicate device (C630G, K222121).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table against a predicate device, which indicates the performance criteria and how the proposed devices (C660G and C810G) compare. The acceptance criteria are implicitly those of the predicate device and relevant industry standards.
| Attribute | Acceptance Criteria (Predicate C630G) | Reported Device Performance (Proposed C660G LCD Monitor) | Reported Device Performance (Proposed C810G LCD Monitor) |
|---|---|---|---|
| Display Performance/Specifications | |||
| Screen technology | 30 inches, Color-TFT LCD Panel | 30 inches, Color-TFT LCD Panel | 31.5 inches, Color-TFT LCD Panel |
| Viewing angle (H, V) | Horizontal 178°, Vertical 178° | Horizontal 178°, Vertical 178° | Horizontal 178°, Vertical 178° |
| Resolution | 3280x2048 | 3280x2048 | 3840x2160 |
| Display area | 645.5 (H) mm × 403 (V)mm | 645.5 (H) mm × 409.3 (V)mm | 697.31 (H) mm × 392.23 (V)mm |
| Contrast Ratio | 1000:1 | 2000:1 | 1300:1 |
| DICOM calibrated luminance | 500cd/m² | 800 cd/m² | 1000cd/m² |
| Pixel Pitch | 0.197mm × 0.197mm | 0.197mm × 0.197mm | 0.1816mm × 0.1816mm |
| Backlight | LED | LED | LED |
| DICOM LUT | 16-bit:65536 | 16-bit:65536 | 14-bit:16384 (outputs 10-bit images) |
| Luminance calibration | Built in calibration sensor provided | Built in calibration sensor provided | Built in calibration sensor provided |
| Video Signal Input | |||
| Input signals | DisplayPort 1.2a, DVI | DisplayPort 1.2a, Type-C, DVI | DisplayPort 1.2a, DVI |
| Input terminational | DisplayPort × 2, DVI × 1 | DisplayPort × 2, Type-C, DVI × 1 | DisplayPort × 2, DVI × 1 |
| Output signals | DisplayPort 1.2a | DisplayPort 1.2a | NA |
| Output Terminational | DisplayPort × 1 | DisplayPort × 1 | NA |
| Display controller | Off the shelf | Off the shelf | Off the shelf |
| Power Related Specification | |||
| Power Requirement | 24VDC-9.2A | 24VDC-6.25A | 24V 5A |
| Power Consumption/Save Mode | 150W/less than 0.5W | 150W/less than 0.5W | 120W/less than 0.5W |
| Power Management | DisplayPort 1.2a | DisplayPort 1.2a | DisplayPort 1.2a |
| Miscellaneous Features/Specifications | |||
| USB Ports/standard | 1 upstream (endpoint), 2 downstream/ Rev. 2.0 | 1 upstream (endpoint), 2 downstream/ Rev. 2.0 | 1 upstream (endpoint), 2 downstream/ Rev. 2.0 |
| Indication for use | Same as proposed devices | C660G/C810G 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 does not support the display of mammography images for diagnosis. | Same as C660G |
| Applicable Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states that no clinical studies were required to support substantial equivalence for this device (medical image display monitors). The testing performed was "Bench testing" and "Electrical safety and electromagnetic compatibility (EMC) testing" on the physical devices themselves. Therefore, there is no "test set" in the context of clinical data, no sample size of patients/cases, and no data provenance from patients/cases.
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. As noted above, no clinical studies with expert-established ground truth were performed or required for this device type. The performance evaluation relied on engineering bench testing and compliance with recognized standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring expert adjudication was used.
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 a display monitor, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI-assistance comparison was conducted.
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)
Not applicable. The "ground truth" for evaluating this device's performance is objective technical specifications and compliance with international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2) and display performance (TG18 guideline).
8. The sample size for the training set
Not applicable. This device is a display monitor and does not involve machine learning algorithms requiring a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set.
§ 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).