(50 days)
JUSHA-C270G/JUSHA-C270/C270G/C270 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 does not support the display of mammography images for diagnosis.
JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor is the display system with the high resolution (1600*1200), high luminance (600 cd/m²), and 281.47 trillion colors, built-in DICOM standard LUT. In particular, JUSHA-C270G has ambient brightness adapting, real-time DICOM automatic calibration 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 - DMX0302CR0/main board/V1.2 - JUSHA-C270G LCD Monitor software - Power Adapter - Data Cable.
The provided document is a 510(k) summary for the JUSHA-C270G/JUSHA-C270/C270G/C270 LCD Monitor. It describes the device, its intended use, and its substantial equivalence to a predicate device (JUSHA-C23C, K151861). The document focuses on demonstrating that the new device is as safe and effective as the predicate device through non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document defines "acceptance criteria" through compliance with recognized standards and a comparison to a predicate device. The reported performance is based on bench testing.
| Acceptance Criteria Category | Specific Acceptance Criteria (from recognized standards or comparison) | Reported Device Performance (JUSHA-C270G) |
|---|---|---|
| Electrical Safety | Compliance with 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 | Complies with IEC 60601-1 standard for safety. |
| EMC | Compliance with IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017 | Complies with IEC 60601-1-2 standard for EMC. |
| Display Performance | - Maximum resolution values same as JUSHA-C23C (1600x1200) |
- Luminance calibration built-in
- Contrast Ratio (1400:1)
- Pixel Pitch (0.27x0.27 mm)
- Ability to display general X-ray or MRI images for diagnosis.
- No support for mammography images for diagnosis. | - Resolution: 1600 x 1200 / 1200 x 1600 (Same as predicate)
- Luminance calibration: Built-in calibration sensor provided (Same as predicate)
- Contrast Ratio: 1400:1 (Same as predicate)
- Pixel Pitch: 0.27x0.27 mm (Same as predicate)
- Intended for displaying and viewing digital images for diagnosis of X-ray or MRI, etc. (Same as predicate)
- Does not support the display of mammography images for diagnosis. (Same as predicate) |
| Bench Test Metrics | Performance measurements according to TGI18 guideline: - Angular dependency of luminance response
- Luminance non-uniformity
- Chromaticity non-uniformity
- Small-spot contrast ratio
- Temporal response
- Luminance stability | Bench tests were conducted to demonstrate the JUSHA-C270G meets all performance standards defined by these specific measurements. (Specific numeric results are not provided in this summary). |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. The "test set" in this context refers to the physical device being tested against established (non-clinical) performance criteria and standards, rather than a dataset of medical images.
- Data Provenance: Not applicable for a device performance test. The tests were performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a medical display monitor, and its performance evaluation relates to technical specifications and compliance with standards, not diagnostic accuracy based on expert interpretation of images. No ground truth in the sense of medical diagnoses was established for this submission.
4. Adjudication method for the test set:
- Not applicable. As noted above, this submission is for a medical display monitor and does not involve adjudication of diagnostic interpretations.
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 MRMC comparative effectiveness study was done. This device is a display monitor, not an AI-powered diagnostic tool. Clinical studies were explicitly stated as not required to support substantial equivalence.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a display monitor, not an algorithm. Performance tests measured the monitor's technical specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's performance is established by compliance with international and national standards (e.g., IEC 60601-1, IEC 60601-1-2, TGI18 guideline) and comparison to the technical specifications of a predicate device.
8. The sample size for the training set:
- Not applicable. This device is a display monitor, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As this is not an algorithm requiring a training set, no ground truth for a training set was established.
§ 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).