(252 days)
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
JUSHA-C1210G/JUSHA-C1210/C1210G/C1210 LCD Monitor is the display system with the high resolution (4200x2800), high luminance (800 cd/m²), and 16-bit grayscale (65536 level), built-in DICOM standard LUT. In particular, JUSHA- C1210G has ambient brightness adapt inside. In particular, JUSHA- C1210G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization 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:
- 31" Color-TFT LCD Panel
- DMF2604AR0/main board/REV1.0
- JUSHA-C1210G LCD Monitor software
- Power Adapter
- Data Cable.
Here's a breakdown of the acceptance criteria and the study information for the JUSHA-C1210G LCD Monitor, 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" with corresponding reported device performance values in a direct, comparative format. Instead, it describes various performance evaluations that were conducted and states that the device "meets all performance standards" and "complies with" certain industry standards.
The acceptance criteria are implicitly defined by the standards and performance measurements listed under "Bench testing" and "Electrical safety and electromagnetic compatibility (EMC)". The reported device performance is indicated by the general statement of compliance.
Therefore, the table below is constructed by inferring the acceptance criteria from the tests mentioned and noting the general statement of compliance as the "reported device performance."
| Acceptance Criteria (Implicit from Tests) | Reported Device Performance (General Statement) |
|---|---|
| Measurement of angular dependency of luminance response | Meets all performance standards |
| Measurement of luminance non-uniformity characteristics (TG18) | Meets all performance standards |
| Measurement of chromaticity non-uniformity characteristics (TG18) | Meets all performance standards |
| Measurement of small-spot contrast ratio | Meets all performance standards |
| Measurement of temporal response | Meets all performance standards |
| Performance data on luminance stability | Meets all performance standards |
| Electrical safety (IEC 60601-1) | Complies with IEC 60601-1 |
| Electromagnetic compatibility (EMC) (IEC 60601-1-2) | Complies with IEC 60601-1-2 |
2. Sample Size Used for the Test Set and the Data Provenance
The document describes "bench testing" of the LCD monitor. For a display device, the "test set" would typically refer to the specific unit(s) of the device being evaluated. However, the document does not specify the sample size (number of units) used for these bench tests.
The data provenance is also not explicitly stated. It's generally inferred that bench testing is conducted by the manufacturer (Nanjing Jusha Display Technology Co., Ltd. in China), but specific country of origin for the test data, or whether it's retrospective or prospective testing, is not detailed. Given it's a premarket submission, the testing would be prospective for the device seeking clearance.
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 and therefore not provided in the document. The device is an LCD monitor, a hardware display system, not an AI algorithm or diagnostic tool that requires expert-established ground truth for its performance evaluation (e.g., image interpretation). Its performance is assessed through objective physical and electrical measurements.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluations are objective technical measurements of a hardware device's performance against established standards, not subjective interpretations requiring adjudication.
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 comparative effectiveness study was not done. This type of study is relevant for AI algorithms in medical image analysis, not for a standalone hardware display monitor. The document explicitly states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence."
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a standalone performance evaluation was done, in the sense that the device's performance was assessed purely on its technical specifications and compliance with standards, without direct human interaction as part of the performance measurement itself. This is what "bench testing" and "electrical safety and EMC" evaluations represent for a display monitor. There is no "algorithm" in the context of an AI device, but rather the intrinsic performance of the display hardware.
7. The Type of Ground Truth Used
For a medical display monitor, the "ground truth" for its performance is typically defined by:
- Industry standards and specifications: Such as those from AAPM (American Association of Physicists in Medicine) or DICOM (Digital Imaging and Communications in Medicine) for display characteristics. The document mentions compliance with "TG18 guideline" (likely AAPM TG18 for display quality control) and "DICOM standard LUT."
- International safety and EMC standards: Specifically IEC 60601-1 and IEC 60601-1-2.
These standards and guidelines serve as the objective "ground truth" against which the monitor's physical, photometric, and electrical properties are measured and evaluated for compliance.
8. The Sample Size for the Training Set
This information is not applicable. The device is an LCD monitor, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is not an AI algorithm requiring a training set with ground truth.
§ 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).