(64 days)
JUSHA-C23C LCD Monitor is intended to be used in displaying 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.
JUSHA-C23C LCD Monitor is the display system with the high resolution (1600*1200), high luminance 600cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table and 3 GAMMA look up table inside. JUSHA-C23C 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, Color-TFT LCD Panel
- JUSHA-SMS_19inch motherboard/FR-4/REV:0.1
- JUSHA-C23C 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.
This document is a 510(k) Premarket Notification from the FDA regarding the "JUSHA-C23C LCD Monitor". It largely focuses on demonstrating substantial equivalence to a predicate device ("RADIFORCE RX240").
Here's an analysis based on your request, highlighting the information available and what is not present (which is typical for a display monitor 510(k) submission, as they generally don't involve complex AI models or extensive clinical studies in the same way an AI-powered diagnostic device would):
Key takeaway for this specific document: This application is for an LCD monitor. The "acceptance criteria" and "study" are focused on demonstrating the monitor's display performance and adherence to safety/EMC standards, not on an AI algorithm's diagnostic performance. Therefore, many of your requested points related to AI/MRMC studies or expert ground truth for diagnostic accuracy are not applicable to this kind of device.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present an explicit "acceptance criteria" table in the way one might for a diagnostic AI. Instead, it demonstrates compliance through comparisons to a predicate device and adherence to recognized standards. The key performance aspects are listed as "Bench testing" results, aiming to show that the monitor performs adequately for medical image display.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Display Performance | ||
| Resolution | Equivalent to predicate (1600x1200/1200x1600) | 1600x1200/1200x1600 |
| Screen Technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel |
| Viewing Angle (H, V) | Horizontal 176°; Vertical 176° | Horizontal 176°; Vertical 176° |
| Display Area | 432.0 (H) x 324.0 (V) mm | 432.0 (H) x 324.0 (V) mm |
| Recommended Luminance | 400 cd/m² | 400 cd/m² |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm |
| Backlight | LED | LED |
| DICOM LUT | At least 10-bit (1024 shades) or better than predicate | 12-bit (4096 shades) |
| Luminance Calibration | Built-in calibration sensor provided | Built-in calibration sensor provided |
| Contrast Ratio | Comparable to predicate (1200:1) | 1400:1 (Better than predicate, justified by different panel) |
| Scanning Freq. (H; V) | Acceptable range (Predicate: 31-100 kHz; 59-61Hz) | 52-76 kHz; 59-61Hz (Difference noted but deemed not affecting display function) |
| Bench Test Measurements | Meet standards/guidelines (e.g., TG18 guideline) | Passed: Measurement of angular dependency, luminance non-uniformity, chromaticity non-uniformity, small-spot contrast ratio, temporal response, luminance stability |
| Electrical Safety | Compliance with IEC 60601-1 | Complies with IEC 60601-1 |
| EMC | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2 |
| Power Requirement | AC 100-240V 50-60Hz | AC 100-240V 50-60Hz |
| Power Consumption | Acceptable (Predicate: 52W/less than 1.6W) | 65W/less than 2.5W (Difference noted but deemed not affecting display function) |
Study Details (Focusing on Display Monitor Testing)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of diagnostic images/patient cases. The "test set" here refers to the physical monitor undergoing various bench tests. These tests are performed on the device itself.
- Data Provenance: Not applicable for a display monitor. The "data" are the measurements of the monitor's performance characteristics. This device is manufactured in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For a display monitor, "ground truth" is measured by calibrated instruments against physical and electrical performance standards (e.g., luminance, resolution, color accuracy). It's not about clinical interpretation by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies where human readers interpret medical images. For a monitor, test results are objective 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:
- No. An MRMC study is relevant for AI-powered diagnostic devices where the AI assists human readers in diagnosis. This document is for an LCD monitor, which is a display component and not a diagnostic AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is not an AI algorithm; it's a medical display monitor. Standalone performance testing would refer to the monitor's physical and electrical characteristics as listed in the bench testing section.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Physical/Electrical Standards and Measurements. The "ground truth" for a display monitor's performance is adherence to established technical specifications and internationally recognized standards for medical displays (e.g., DICOM Part 14, TG18 guidelines, IEC 60601 series). These are objective, measurable criteria.
8. The sample size for the training set:
- Not applicable. This device is an LCD monitor, not an AI algorithm. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI algorithm, there is no ground truth established in this context. The "ground truth" for the monitor's acceptable performance is defined by industry standards and regulatory requirements for medical displays.
In summary: This document clearly describes a 510(k) submission for a medical display monitor. The "acceptance criteria" and "study" described are focused on proving the monitor's technical specifications meet declared performance, are safe, and are electromagnetically compatible, aligned with relevant IEC standards and comparisons to a legally marketed predicate device. The nature of the device (a display hardware component) means that aspects related to complex AI algorithms, clinical diagnostic accuracy, human reader studies, or expert ground truth for interpretation are not within the scope of this submission.
§ 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).