(123 days)
JUSHA-CP610 LCD Monitor, CP610 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-CP610/CP610 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD Monitor is portable and light, the 850g weight make it is easy to carry. 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:
- 13.5" Color TFT LCD Panel
- DMS0600A board/4 layer/233*127mm/1.0mm/REV:1.1
- JUSHA-CP610 LCD Monitor software
- Power Adapter
- Data Cable.
The software that supports the functions of the CP610 is the same as the software used with the predicate JUSHA C61. The level of concern was determined to be Moderate for the JUSHA-CP610 LCD Monitor.
The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
- 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.
- 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.
The provided document is a 510(k) summary for the JUSHA-CP610 LCD Monitor. It describes the device, its intended use, and a comparison to a predicate device (JUSHA-C61 LCD Monitor) to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" in a clearly defined pass/fail format for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and adherence to relevant standards. The "performance" described is in terms of meeting these standards and having comparable or improved technical characteristics.
Here's an attempt to structure the information as requested, drawing from the "Product Comparison" table and "Performance Data" section. Note that "acceptance criteria" for a display device are often encapsulated by adherence to industry standards for medical displays.
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (JUSHA-CP610) |
|---|---|
| Adherence to IEC 60601-1 (Electrical Safety) | Complies 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 |
| Adherence to IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017 |
| Maximum Resolution (>= 6 megapixels of predicate) | 3000x2000 (stated as meeting 6megapixels requirement) |
| Screen Technology | Color TFT LCD Panel |
| Viewing Angle | Horizontal 170°, Vertical 170° |
| Backlight Type | LED |
| Intended Use | Displaying and viewing digital images for diagnosis of X-ray or MRI, etc. (does not support mammography) |
| Luminance Response Angular Dependency | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Luminance Non-uniformity (TG18 guideline) | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Chromaticity Non-uniformity (TG18 guideline) | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Small-spot Contrast Ratio | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Temporal Response | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Luminance Stability | Performance data compiled. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Power Consumption (for demonstration of difference) | 15W (Predicate: 100W) - This is a difference noted, not an "acceptance criterion" per se, but shows characterization. |
| Display Colors (for demonstrating improvement) | 14-bit, 4398 billion colors (Predicate: 12-bit, 68.7 billion colors) - This is an improvement, not an "acceptance criterion," but demonstrates a characteristic. |
| Pixel Pitch (for demonstrating improvement) | 0.0951x0.0951mm (Predicate: 0.197x0.197mm) - This is an improvement, not an "acceptance criterion," but demonstrates a characteristic which improves pixel density. |
Here's the additional information requested:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of clinical data for software performance. The device is a display monitor, and its performance was evaluated through bench testing and adherence to international standards. There is no information about data provenance or sample size for a "test set" of medical images as it primarily relies on the physical and electrical characteristics of the display. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The ground truth concept for clinical performance data is not relevant here as the device is a display monitor, not an AI algorithm performing diagnosis. The "truth" for this device lies in its ability to accurately and consistently display images according to technical specifications and standards (e.g., DICOM standard LUT). -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" or clinical adjudication process described for this display device. -
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. This is a display monitor, not an AI-powered diagnostic system. No MRMC study was conducted or is relevant for this type of device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display monitor, not a standalone algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a display monitor, the "ground truth" used for evaluation is based on technical specifications, industry standards (e.g., DICOM, TG18), and physical measurements. The performance data section describes measurements against these standards (e.g., luminance, chromaticity, contrast ratio). -
The sample size for the training set
Not applicable. The device is a display monitor, not an AI algorithm that requires a training set. -
How the ground truth for the training set was established
Not applicable, as there is no training set for this 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).