(63 days)
C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1150 cd/m2), and 16-bit (65536 level), built-in DICOM standard LUT. In particular, C510G 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:
- 21.3" Color-TFT LCD Panel
- DMX0704AR1/Main Board/REV: 1.2
- C510G LCD Monitor software
- Power Adapter
- Data Cable.
The provided text describes the regulatory clearance for the Nanjing Jusha Display Technology Co., Ltd's C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor. This device is a medical display intended for viewing and diagnosing digital images, including mammography and breast tomosynthesis applications.
Crucially, the document states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." and "The subject of this premarket submission, C510G, does not require animal or clinical studies to support substantial equivalence."
Therefore, the following points regarding acceptance criteria and study proving performance are not applicable as they relate to clinical studies or studies using ground truth established by experts/pathology/outcomes data. The device's clearance was based on demonstrating substantial equivalence to a predicate device (JUSHA-M550G; K190848) through non-clinical bench testing and adherence to relevant standards.
Based on the provided document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document describes performance measurements that were conducted as part of bench testing, but it does not specify explicit "acceptance criteria" values against which these measurements were compared. Instead, it states that the device "meets all performance standards" and "complies with" certain IEC standards. The comparison table shows the specifications of the proposed device against the predicate.
| Performance Measurement Conducted (Bench Testing) | Proposed Device (C510G) Performance (as reported) | Implicit Acceptance Criteria / Standard Met |
|---|---|---|
| Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions | Data not explicitly detailed, assumed to meet standards | TGI18 guideline (implied, not explicitly stated as a pass/fail value) |
| Measurement of the luminance non-uniformity characteristics of the display screen | Data not explicitly detailed, assumed to meet standards | TGI18 guideline (implied, not explicitly stated as a pass/fail value) |
| Measurement of the chromaticity non-uniformity characteristics of the display screen | Data not explicitly detailed, assumed to meet standards | TGI18 guideline (implied, not explicitly stated as a pass/fail value) |
| Measurement of small-spot contrast ratio | Data not explicitly detailed, assumed to meet standards | Not specified |
| Measurement of temporal response | Data not explicitly detailed, assumed to meet standards | Not specified |
| Performance data on luminance stability | Data not explicitly detailed, assumed to meet standards | Not specified |
| Electrical safety and electromagnetic compatibility (EMC) | Complies with IEC 60601-1 and IEC 60601-1-2 | IEC 60601-1 and IEC 60601-1-2 standards |
| Key Display Specifications (from Product Comparison Table): | Proposed Device (C510G) Specification | Predicate Device (JUSHA-M550G) Specification (for comparison, not acceptance criteria) |
| Resolution | 2560 x 2048 / 2048 x 2560 | 2560 x 2048 / 2048 x 2560 (Same) |
| Contrast Ratio | 2000:1 | 1700:1 (Better) |
| DICOM calibrated luminance | 500 cd/m2 | 1000 cd/m2 (Different panels with different brightness, but same 5MP resolution for Mammo diagnosis) |
| Pixel Pitch | 0.165 x 0.165 mm | 0.165 x 0.165 mm (Same) |
| DICOM LUT | 16-bit: 65536 | 16-bit: 65536 (Same) |
The following information cannot be provided from the given document because the device did not require clinical studies for its substantial equivalence determination:
2. Sample size used for the test set and the data provenance: Not applicable (no clinical test set).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (no clinical test set requiring ground truth).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (no clinical test set 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: Not applicable (no AI component, no MRMC study).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (this is a display monitor, not an algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (no clinical study or ground truth required).
8. The sample size for the training set: Not applicable (no training set for a display monitor).
9. How the ground truth for the training set was established: Not applicable (no training set).
§ 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).