(29 days)
JUSHA-M53 Medical Display is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners.
JUSHA-M53 Medical Display is a display system with the high resolution (2560 x 2048), high luminance (1000 cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 8 DICOM look up table with 12 bit inside. It is compliant with DICOM Part 14, and it has front sensor, presents induction system and ambient brightness adapting function. JUSHA-M53 employs energy efficient LED as backlight, it can achieve a high brightness and low power consumption at the same time. LED backlights deteriorate more slowly and thus the monitor offers a long service time.JUSHA-M53 with 10 bit (1024 tones) simultaneous grayscale display extends graysacle fidelity to the boundaries of human visual perception abilities and helps radiologists discern the finest nuances within an image.
The product is consisted of the following components:
- 21.3 inch, mono-TFT Liquid Crystal Display
- -JUSHA-45T Motherboard/FR-4/REV1.0
- JUSHA-M53 Medical Display software
- Power Adapter
- Data Cable.
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is present and what is not explicitly detailed:
Device: JUSHA-M53 Medical Display
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" for the JUSHA-M53 beyond general compliance with industry standards and substantial equivalence to the predicate device. However, a detailed comparison table of technological characteristics to the predicate device (Eizo Nanao Corporation's RadiForce GX540, K130336) is provided, implying these are the performance metrics against which "acceptance" for substantial equivalence is being measured.
| Feature / Metric | Predicate Device (RADIFORCE GX540) | Proposed Device (JUSHA-M53 Medical Display) | Performance (as reported for JUSHA-M53) | Acceptance Criteria (Implied from Predicate Comparison) | Met (Y/N) |
|---|---|---|---|---|---|
| Screen technology | 21.3" TFT Monochrome LCD Panel | 21.3" TFT Monochrome LCD Panel | 21.3" TFT Monochrome LCD Panel | Same as predicate | Y |
| Viewing angle (H,V) | Horizontal 176°, Vertical 176° | Horizontal 176°, Vertical 176° | Horizontal 176°, Vertical 176° | Same as predicate | Y |
| Resolution | 2048 x 2560 | 2048 x 2560 | 2048 x 2560 | Same as predicate | Y |
| Display area | 337.9 x 422.4 mm | 337.9 x 422.4 mm | 337.9 x 422.4 mm | Same as predicate | Y |
| Aspect ratio | 4:5 | 4:5 | 4:5 | Same as predicate | Y |
| Contrast Ratio (typ) | 1200:1 | 1200:1 | 1200:1 | Same as predicate | Y |
| Recommended brightness | 500cd/m² | 500cd/m² | 500cd/m² | Same as predicate | Y |
| Pixel Pitch | 0.165 x 0.165 mm | 0.165 x 0.165 mm | 0.165 x 0.165 mm | Same as predicate | Y |
| Backlighting | LED backlight | LED backlight | LED backlight | Same as predicate | Y |
| Grayscale | 1024 | 1024 | 1024 | Same as predicate | Y |
| Response time | 25ms | 25ms | 25ms | Same as predicate | Y |
| Sensors | Backlight, Integrated front, Presence, Ambient light | Backlight, Integrated front, Presence, Ambient light | Backlight, Integrated front, Presence, Ambient light | Same as predicate | Y |
| Input signals | DVI standard 1.0 | DVI standard 1.0 | DVI standard 1.0 | Same as predicate | Y |
| Input termination | 1 DVI-D Dual Link, 1 Display Port | 1 DVI-D Dual Link, 1 Display Port | 1 DVI-D Dual Link, 1 Display Port | Same as predicate | Y |
| Display controller | Off the shelf | Off the shelf | Off the shelf | Same as predicate | Y |
| Scanning Freq. (H,V) (Predicate) | 31-135 kHz / 24-61 Hz | 123 KHz / 60 Hz | 123 KHz / 60 Hz | To be demonstrated as acceptable for medical imaging | Y (Implied) |
| Power Requirement | 100-120 Vac, 50/60 Hz, 1.1-0.9A; 200-240 Vac, 50/60 Hz, 0.6-0.5A | 100-120 Vac, 50/60 Hz, 1.1-0.9A; 200-240 Vac, 50/60 Hz, 0.6-0.5A | 100-120 Vac, 50/60 Hz, 1.1-0.9A; 200-240 Vac, 50/60 Hz, 0.6-0.5A | Same as predicate | Y |
| Power Consumption/Save Mode (Predicate) | 108W / less than 0.7W | 48.9W / less than 1.5W | 48.9W / less than 1.5W | Lower/comparable consumption is generally favorable | Y (Improved efficiency) |
| Power Management | DVI DMPM | DVI DMPM | DVI DMPM | Same as predicate | Y |
| USB Ports/standard | 1 upstream (endpoint), 2 downstream | 1 upstream (endpoint), 2 downstream | 1 upstream (endpoint), 2 downstream | Same as predicate | Y |
| Indications for use | Displaying & viewing digital images, including digital mammography, for review & analysis by trained medical practitioners | Displaying & viewing digital images, including digital mammography, for review & analysis by trained medical practitioners | Same as predicate | Same as predicate | Y |
| Applicable Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Complies with both standards | Compliance with standards | Y |
The key acceptance criterion seems to be "substantial equivalence" to the predicate device, demonstrated by matching or comparable technological characteristics and compliance with relevant safety and EMC standards.
2. Sample size used for the test set and the data provenance
The document specifies "Bench testing" was conducted on the JUSHA-M53. However, it does not provide details on the sample size (e.g., number of displays tested) nor the data provenance. It describes performance data as being obtained from the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the testing described is bench testing of a medical display, not a clinical study involving human interpretation of images and ground truth established by experts.
4. Adjudication method for the test set
This information is not applicable for the same reason as point 3.
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
This information is not applicable. The device is a medical display, not an AI-powered diagnostic or assistive tool. No MRMC study was mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a medical display, not an algorithm.
7. The type of ground truth used
The document describes "Bench testing" for physical and electrical performance (luminance response, uniformity, contrast ratio, temporal response, stability, electrical safety, EMC). The "ground truth" for these tests would be the measurement standards and technical specifications (e.g., TG18 guideline for display characteristics, IEC 60601 series for safety/EMC). There is no "pathology" or "outcomes data" ground truth involved, as it is a display device, not an image interpretation algorithm or a treatment.
8. The sample size for the training set
This information is not applicable. The device is a medical display, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
§ 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).