(9 days)
The Coronis Fusion 4MP LED (MDCC-4230) Medical Flat Panel Display System is intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The Coronis Fusion 4MP LED (MDCC-4230) is a high-resolution flat panel LCD display system for reviewing medical images. It consists of an LCD display (MDCC-4230), an optional high-resolution display controller board and QA software. The display controller board is installed in a PACS workstation computer, connected to the display. The QA software helps to make and keep the displays DICOM compliant. The display uses LED backlight technology.
The provided document is a 510(k) summary for the Barco Coronis Fusion 4MP LED (MDCC-4230) Medical Flat Panel Display System, which is a display device, not an AI/ML medical device. Therefore, the information typically requested for AI/ML device studies (such as sample size for test/training sets, ground truth methodology, expert qualifications, adjudication methods, MRMC studies, or standalone performance) is not applicable or provided within this document.
The document focuses on demonstrating substantial equivalence to a predicate device (Coronis Fusion 4MP DL, MDCC-4130) by comparing technological characteristics and presenting bench test results related to safety and performance.
Here's a breakdown of the available information relevant to acceptance criteria and device performance:
1. Table of Acceptance Criteria (implicitly, comparison to predicate) and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical performance but rather demonstrates equivalence to a predicate device based on similar or superior characteristics as shown in a table comparing specifications and the results of bench testing.
| Characteristic | Predicate Device (MDCC-4130) Value | Subject Device (MDCC-4230) Value | Performance Description / Test Result |
|---|---|---|---|
| General | |||
| Screen technology | TFT AM LCD Dual Domain IPS Pro | TFT AM LCD Dual Domain IPS Pro | Same |
| Active screen size (diagonal) | 756 mm (29.8") | 756 mm (29.8") | Same |
| Active screen size (H x V) | 641.28 x 400.8 mm (25.2 x 15.8") | 641.28 x 400.8 mm (25.2 x 15.8") | Same |
| Aspect ratio (H:V) | 16:10 | 16:10 | Same |
| Resolution | 4MP (2560 x 1600) | 4MP (2560 x 1600) | Same |
| Pixel pitch | 0.2505 mm | 0.2505 mm | Same |
| Color imaging | Yes | Yes | Same |
| Gray imaging | No | No | Same |
| Viewing angle (H, V) | 178° | 178° | Same |
| Uniform Luminance Technology (ULT) | Yes | Yes | Same |
| Ambient Light Compensation (ALC) | Yes | Yes | Same |
| Backlight Output Stabilization (BLOS) | Yes | Yes | Same |
| I-Guard | Yes | Yes | Same |
| DICOM calibrated luminance (ULT off) | 500 cd/m² | 500 cd/m² | Same |
| Response time (Tr + Tf) | 20 ms | 20 ms | Same |
| Scanning frequency (H; V) | 30-150 kHz; 15-80 Hz | 30-150 kHz; 15-80 Hz | Same |
| Video input signals | DVI-D Dual Link | DVI-D Dual Link / DisplayPort 1.1 | Improvement: Added DisplayPort 1.1 |
| USB ports | 1 upstream (endpoint), 3 downstream (USB 1.0) | 1 upstream (endpoint), 3 downstream (USB 2.0) | Improvement: Upgraded to USB 2.0 |
| Power requirements (nominal) | 100-240V | 100-240V | Same |
| Power save mode | Yes | Yes | Same |
| Differences/Improvements | |||
| Backlight technology | CCFL | LED | Improvement: LED backlight instead of CCFL. Tested via DICOM calibration and Luminance Uniformity tests. |
| Per Pixel Uniformity (PPU) | No (per zone uniformity) | Yes | Improvement: Per Pixel Uniformity. Tested via Luminance Uniformity tests. |
| Maximum luminance | 950 cd/m² | 720 cd/m² | Different, but considered acceptable within the context of medical imaging display standards and DICOM calibration targets. |
| Contrast ratio (typical) | 1100:1 | 1000:1 | Different, but considered acceptable. |
| Power consumption (nominal) | 135W | 105W | Improvement: Lower power consumption. |
| Net weight with stand | 28.1 kg | 21.5 kg | Improvement: Lighter. |
| Net weight w/o stand | 21.6 kg | 15 kg | Improvement: Lighter. |
| Firmware | Specific to MDCC-4130 | New (different platform) | Firmware tests performed. |
| Front filter material | Unspecified | Different material | Impact test in IEC 60601-1 tests. |
| Sheet metal parts material | Unspecified | Other material | Shock and Vibration tests in Environmental test report. |
| Electrical Safety | Conformed to standards | Conforms to IEC 60601-1 | Additional test performed: Electrical Safety test (IEC 60601-1). |
| EMC | Conformed to standards | Conforms to IEC 60601-1-2 | Additional test performed: EMC test (IEC 60601-1-2). |
The conclusion states: "The tests showed that the device has similar or superior characteristics compared to the predicate device and did not reveal new issues of safety and performance."
The questions about sample size, ground truth, experts, adjudication, and MRMC studies are not applicable to this type of device (a medical display monitor) and therefore are not found in the provided document. The device is evaluated based on its physical and technical specifications, and its ability to meet relevant performance and safety standards, rather than its interpretive output on medical images. No animal or clinical testing was performed.
§ 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).