(39 days)
JUSHA-M33C 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 is not specified for digital mammography system.
JUSHA-M33C LCD Monitor is the display system with the high resolution (2048*1536), high luminance (1000 cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 10 DICOM look up table and 3 GAMMA look up table inside. JUSHA-M33C 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, Mono-TFT LCD Panel
- JUSHA- 45T motherboard/FR-4/REV:0.9
- JUSHA-M33C 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 is a 510(k) Premarket Notification for the JUSHA-M33C LCD Monitor. This document is for a medical display device, not an AI/ML powered device, therefore, many of the requested criteria related to AI/ML studies are not applicable.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the way one might expect for a diagnostic AI model (e.g., sensitivity, specificity, AUC thresholds). Instead, the acceptance criteria for a medical display monitor are implicitly tied to demonstrating substantial equivalence to a legally marketed predicate device (EIZO GX340) by meeting relevant performance and safety standards.
The table below summarizes the key performance characteristics provided for the proposed device and its predicate. The "acceptance criteria" here are essentially the predicate device's specifications, which the proposed device aims to match or exceed to demonstrate substantial equivalence.
| Attribute | Acceptance Criteria (Predicate: EIZO GX340) | Reported Device Performance (JUSHA-M33C LCD Monitor) |
|---|---|---|
| Screen Technology | 21.3" Monochrome TFT LCD Panel | 21.3 inches, Mono-TFT LCD Panel |
| Viewing Angle (H, V) | Horizontal 176°, Vertical 176° | Horizontal 176°, Vertical 176° |
| Resolution | 2048 x 1536 / 1536 x 2048 | 2048 x 1536 / 1536 x 2048 |
| Display Area | 324.8 (H) x 433.1 (V) mm | 325.00 (H) x 433.00 (V) mm |
| Contrast Ratio | 1400:1 | 1400:1 |
| Scanning Freq (H; V) | 31 | 96.7 kHz; 60 Hz |
| Recommended Luminance | 500 cd/m² | 500 cd/m² |
| Pixel Pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm |
| Backlight | LED | LED |
| DICOM LUT | 10-bit (Display Port): 1024; 8-bit: 256 | 4096 |
| 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) x 1, DisplayPort x 1 | DVI-D (dual link) x 1, DisplayPort x 1 |
| Display Controller | Off the shelf | Off the shelf |
| Power Requirement | AC 100 | AC 100 |
| Power Consumption/Save Mode | 36W / less than 1.6W | 45W / less than 3W |
| Power Management | DVI DMPM, DisplayPort 1.1a | 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 Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 |
Study to Prove Acceptance Criteria:
The study proving the device meets the acceptance criteria is implicit within the "Determination of Substantial Equivalence" section. The document states:
- "The LCD Monitor complies with voluntary standards as following: IEC 60601-1... IEC 60601-1-2..." These indicate testing was performed to demonstrate compliance with these safety and essential performance standards.
- "JUSHA-M33C is substantially equivalent to EIZO GX340. JUSHA-M33C employs the maximum resolution values same as that of EIZO GX340. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1." The comparison table (reproduced above) is the primary "study" or evidence to support the claim of substantial equivalence based on technical specifications.
2. Sample Size Used for the Test Set and Data Provenance
This is not applicable as this is a hardware device (LCD monitor), not a software algorithm that processes medical images. The "test set" here refers to the device itself being tested against standards and compared to a predicate, not a dataset of patient images.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This is not applicable. Ground truth, in the context of image interpretation, is not established for a medical display device during its 510(k) submission. The performance of the monitor is assessed by technical specifications and compliance with standards, not by expert consensus on medical images displayed on it for the purpose of regulatory submission.
4. Adjudication Method for the Test Set
This is not applicable. As explained above, the "test set" and ground truth for image interpretation are not relevant for this hardware device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms in conjunction with human readers, 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
No, a standalone performance study was not done. This device is an LCD monitor, not an algorithm. Its function is to display images for human interpretation, not to make diagnostic decisions independently.
7. The Type of Ground Truth Used
The "ground truth" for this medical device submission is the adherence to established technical specifications, industry standards (IEC 60601-1, IEC 60601-1-2), and the demonstrated equivalence to a predicate device's performance. It is not based on expert consensus on image interpretation, pathology, or outcomes data, as these relate to the content displayed, not the display hardware itself.
8. The Sample Size for the Training Set
This is not applicable, as this is a hardware device and does not involve AI/ML training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as there is no training set for this hardware device.
§ 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).