(63 days)
JUSHA-C630G/JUSHA-C630G/C630/C630 LCD Monitor is intended to be used in displaying digital images for diagnosis of X-ray or MRL, et. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
JUSHA-C630G/JUSHA-C630/C630G/C630 LCD Monitor is the display system with the high resolution (3280×2048), high luminance (1050 cd/m2), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, C630G contains GAMMA2.2/GAMMA2.4 LUT. In addition, C630G has ambient brightness adaptation inside, real-time DICOM automatic calibration, full-screen brightness equalization and presence induction system, therefore this display automatically adjust according to different requirements to achieve the best results. The product is consisted of the following components: - 30" Color TFT LCD Panel - DMX0704AR0/main board/REV:1.1 - JUSHA-C630G 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: 1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance. 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
Based on the provided FDA 510(k) summary for the Nanjing Jusha Display Technology Co., Ltd. JUSHA-C630G LCD Monitor, here's an analysis of the acceptance criteria and study proving they are met:
This document is for a medical display device (LCD monitor), not an AI algorithm for image analysis. Therefore, many of the typical questions for an AI device's performance study (such as sample size for test/training sets, experts for ground truth, MRMC studies, etc.) are not applicable to this type of device. The "study" here primarily refers to bench testing to ensure the monitor meets display performance standards.
The primary method for demonstrating substantial equivalence for this device is bench testing against established industry standards and comparison to a predicate device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from "Bench testing" section) | Reported Device Performance (from "Bench testing" section) |
|---|---|
| Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions | The device "meets all performance standards" and "complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC." (Specific numerical performance values are not provided in this summary, but the report states it meets the standards.) |
| Measurement of the luminance non-uniformity characteristics of the display screen as specified in TG18 guideline. | Same as above. |
| Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in TG18 guideline. | Same as above. |
| Measurement of small-spot contrast ratio. | Same as above. |
| Measurement of temporal response | Same as above. |
| Performance data on luminance stability | Same as above. |
| Electrical safety (compliance with IEC 60601-1) | Complies with IEC 60601-1 standard for safety. |
| Electromagnetic compatibility (EMC) (compliance with IEC 60601-1-2) | Complies with IEC 60601-1-2 standard for EMC. |
Note: The 510(k) summary asserts that the device meets the performance standards, but does not explicitly provide the numerical results of each test. This is common in 510(k) summaries, where the detailed test reports are submitted to the FDA for review, and the summary highlights the conclusion of compliance.
2. Sample sized used for the test set and the data provenance
- Sample Size: Not applicable in the context of image data for an AI algorithm. This is a hardware device (LCD monitor). The "sample" would be the manufactured unit(s) themselves undergoing physical and electrical bench testing. The document does not specify the number of units tested.
- Data Provenance: Not applicable in the context of patient data. The "data" are measurements taken from the display device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. Ground truth in this context is established by objective measurements based on standards (like AAPM TG18, IEC 60601-1, IEC 60601-1-2) performed by qualified technicians/engineers using calibrated equipment. It does not involve human interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This refers to the resolution of discrepancies in expert labeling of medical images, which is not relevant for a display performance study.
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
- MRMC Study: Not applicable. MRMC studies are used to evaluate diagnostic accuracy and reader performance with AI assistance, which is not the purpose of evaluating a diagnostic display.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a display monitor, not an AI algorithm. Its performance is inherent to its physical and electronic characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth for this device's performance is based on established industry and international standards for medical displays (e.g., AAPM TG18 guidelines for display quality; IEC 60601-1 for electrical safety; IEC 60601-1-2 for EMC). Compliance with these objective, measurable benchmarks constitutes the "ground truth" for a display device.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This device does not use machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
- Training Set Ground Truth: Not applicable for the reasons stated above.
Summary for this specific device:
The FDA 510(k) for the JUSHA-C630G LCD Monitor relies on bench testing to confirm compliance with recognized performance and safety standards for medical display devices (e.g., AAPM TG18, IEC 60601-1, IEC 60601-1-2). This assessment ensures the monitor can accurately and safely display medical images for diagnostic purposes. It is explicitly stated that no animal or clinical studies were required to support substantial equivalence for this type of device, as its equivalence is based on technical specifications and adherence to established standards, demonstrating it does not raise new questions of safety or effectiveness compared to its predicate 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).