(49 days)
JUSHA-M350G/JUSHA-M350/M350 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.
JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor is the display system with the high resolution (2048*1560), high luminance (1000 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA-M350G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization, presence induction and focusview function, 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:
- 21.3" Mono-TFT LCD Panel
- DMX0704AR0/main board/REV1.1
- JUSHA-M350G LCD Monitor software
- Power Adapter
- Data Cable.
The provided text describes the 510(k) premarket notification for the JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor. This device is a diagnostic display monitor, not an AI/ML-driven medical device. Therefore, the information requested in the prompt regarding acceptance criteria and study data for AI/ML performance (e.g., sample size for test/training sets, expert ground truth, MRMC studies) is not applicable to this submission.
The document focuses on demonstrating substantial equivalence to a predicate device (JUSHA-M33C) based on technical characteristics, performance specifications (luminance, resolution, contrast, etc.), applicable standards (electrical safety, EMC), and intended use.
Here's a breakdown of the relevant information provided:
1. Acceptance Criteria and Reported Device Performance:
The "acceptance criteria" for this type of device are primarily compliance with recognized standards and demonstration of comparable performance to a predicate device. The performance data is presented as a comparison table between the proposed device and the predicate.
| Attributes | Predicate Device (JUSHA-M33C) | Proposed Device (JUSHA-M350G/JUSHA-M350/M350G/M350) | Discussion of (non-significant) Differences |
|---|---|---|---|
| Display Performance/Specifications | |||
| Screen Technology | 21.3" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Same |
| Viewing Angle (H, V) | Horizontal 176°; Vertical 176° | Horizontal 178°; Vertical 178° | - |
| Resolution | 2048 x 1536/1536x 2048 | 2048 x 1536/1536x 2048 | Same |
| Display Area | 324.864(H) x 433.152 (V) mm | 323.942(H) x 431.923 (V) mm | - (Minor difference attributed to different manufacturing definitions) |
| Contrast Ratio | 1400:1 | 1400:1 | Same |
| Scanning Frequency (H; V) | 96.7kHz; 60Hz | 37.9~95.4kHz; 60Hz | Difference noted as due to different no-display area definition, not affecting display function. |
| Recommended Luminance | 400cd/m² | 450cd/m² | - |
| Pixel Pitch | 0.2115 x 0.2115 mm | 0.2109x0.2109 mm | - |
| Backlight | LED | LED | Same |
| Display Colors | 12-bit, 68.7 billion colors | 16-bit, 281.47 Trillion colors | Proposed device uses color bit expansion technology for improved image clarity. This is presented as an improvement, not a failure. |
| Luminance Calibration | Built-in calibration sensor provided | Built-in calibration sensor provided | Same |
| Video Signal Input | DVI-D (dual link) x 1, DisplayPort x 1 | DVI-D (dual link) x 1, DisplayPort x 1 | - |
| Output Signal | - | DisplayPort x 1 | - (Proposed device has an additional output signal) |
| Display Controller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| Power Requirement | AC 100 | DC 24V | - |
| Power Consumption/Save Mode | 65W/less than 3W | 80W/less than 0.5W | Differences attributed to different adapter and components, not affecting display function. Lower save mode power consumption is an improvement. |
| Power Management | DVI DMPM, DisplayPort 1.1a | DVI DMPM, 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 | Same |
| Dimensions w/o stand (W x H x D) | Without stand: 376mmx505mmx98 mm | ||
| With stand: 376mmx599mmx245.5mm | Without stand: 356mm x476mm x85mm | ||
| With stand: 356mm x525mm x238mm | Different housing design due to different panel size. | ||
| Indication for Use | Same as proposed device | Intended for displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. Does not support display of mammography images for diagnosis. | Same |
| Applicable Standard | IEC 60601-1:2005+CORR.1(2006)+CORR.2(2007), IEC 60601-1-2 Ed. 3:2007 | IEC 60601-1:2012, IEC 60601-1-2 Ed. 4:2014 | Newer versions of standards are met. |
Bench testing was conducted to demonstrate the proposed device meets certain performance standards, including:
- Measurement of the angular dependency of luminance response (horizontal, vertical, diagonal)
- Measurement of the luminance non-uniformity characteristics (per TG18 guideline)
- Measurement of the chromaticity non-uniformity characteristics (per TG18 guideline)
- Measurement of small-spot contrast ratio
- Measurement of temporal response
- Performance data on luminance stability
Electrical safety and electromagnetic compatibility (EMC) testing also showed compliance with IEC 60601-1 and IEC 60601-1-2.
2. Sample size used for the test set and the data provenance:
This is a hardware device (LCD monitor), not an AI/ML diagnostic algorithm. Therefore, there are no "test sets" of patient data in the context of diagnostic accuracy. The "testing" refers to bench testing of the monitor's technical specifications and compliance with electrical/EMC standards. The document does not specify a "sample size" for these bench tests, as it typically involves testing a representative number of units or prototypes to ensure compliance. Data provenance is not applicable in the context of patient data here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth and expert adjudication are relevant for diagnostic algorithms assessing medical images, not for a display monitor.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a display device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for a monitor is its adherence to specified optical and electrical performance parameters, as measured by calibrated equipment, and its compliance with relevant industry standards (e.g., DICOM, IEC).
8. The sample size for the training set:
Not applicable. There is no AI/ML model being trained.
9. How the ground truth for the training set was established:
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).