(39 days)
JUSHA-C61 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-C61 LCD Monitor is the display system with the high resolution (3280*2048), high luminance ( 700cd/m² ), 10 bit display colors expanded to 12 bit color expansion technology, 7 DICOM look up table and one GAMMA2.2 look up table inside. In particular, JUSHA-C61 LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. JUSHA-C61 LCD Monitor 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:
- 30.0 inch, a-Si TFT Liquid Crystal Display
- JUSHA-C61 motherboard/FR-4/REV:2.0
- JUSHA-C61 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 describes a medical display monitor (JUSHA-C61 LCD Monitor) and its substantial equivalence to a predicate device (EIZO RX650) based on non-clinical testing. It does not perform or describe a study related to acceptance criteria for an AI/algorithm's performance.
The document is a 510(k) premarket notification for a hardware device (LCD monitor), not an AI algorithm. Therefore, many of the requested categories (expert ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this submission.
Here's an analysis based on the information available:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of an algorithm's performance. Instead, it demonstrates substantial equivalence to a predicate device based on technical specifications and adherence to voluntary and mandatory standards. The "performance" here refers to the technical specifications of the monitor itself.
| Attribute | Predicate Device (EIZO RX650) | Proposed Device (JUSHA-C61 LCD Monitor) |
|---|---|---|
| Screen technology | 30.0" Color TFT LCD Panel | 30.0" Color TFT LCD Panel |
| Viewing angle (H, V) | Horizontal 176°, Vertical 176° | Horizontal 170°, Vertical 170° |
| Resolution | 2048 x 3280 / 3280 x 2048 | 2048 x 3280 / 3280 x 2048 |
| Display area | 645.5(H) x 403.0 (V) mm | 645.5 (H) x 403.0 (V) mm |
| Contrast Ratio | 1000:1 | 1000:1 |
| Recommended Luminance | 400cd/m² | 400cd/m² |
| Pixel Pitch | 0.197x0.197 mm | 0.197x0.197 mm |
| Backlight | LED | LED |
| Display Colors | 10-bit, 1.07 billion colors | 12-bit, 68.7 billion colors (This is actually better, not just equivalent) |
| 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 x2, DisplayPort x2 | DVI-D Dual Link x2, DisplayPort x2 |
| Display controller | Off the shelf | Off the shelf |
| Power Requirement | AC 100 | AC 100 |
| Power Consumption/Save Mode | 108W / less than 6W | 100W / less than 1.5W (Improved power efficiency) |
| Power Management | DVI DMPM | 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 standard | IEC 60601-1, IEC 60601-1-2 Ed 3 | IEC 60601-1, IEC 60601-1-2 Ed 3 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the submission is for a hardware device (monitor), not an AI algorithm evaluated on a test set of medical images. The "testing" referred to in the document pertains to hardware compliance with electrical and safety standards (e.g., IEC 60601-1, IEC 60601-1-2).
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)
This is not applicable. No ground truth for medical images was established or used for the evaluation of this display monitor.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the reasons stated above.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI algorithms on human performance, 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
This is not applicable. There is no "algorithm only" product being evaluated in this submission; it's a display monitor.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable. The device is a display monitor, not a diagnostic algorithm.
8. The sample size for the training set
This is not applicable. The device is a display monitor and does not involve AI training.
9. How the ground truth for the training set was established
This is not applicable.
§ 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).