(57 days)
The Barco MGD 521 5 MegaPixel Diagnostic Display is intended to be used in displaying and viewing digital images for review and analysis by trained medical practitioners.
The MGD 521 device is a diagnostic display. The Barco MGD 521 is a electronic resolution monitor with high resolution capabilities for evaluation of high medical images.
This is a medical device, a Monitor/Display, not an AI/ML device, so many of the requested fields are not applicable.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Displaying and viewing digital images for medical review and analysis. | The Barco MGD 521 is intended to be used in displaying and viewing digital images for medical review and analysis by trained practitioners. |
| High resolution for evaluation of medical images. | The Barco MGD 521 is an electronic resolution monitor with high resolution capabilities for evaluation of high medical images. |
2. Sample Size for Test Set and Data Provenance
Not applicable. This is a hardware display device, not an AI/ML diagnostic tool that processes a "test set" of medical images.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The device's performance is based on its technical specifications for displaying images, not on expert interpretations of data it processes.
4. Adjudication Method
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a display monitor, not an AI system designed to assist human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a display, not an algorithm.
7. Type of Ground Truth Used
Not applicable. The "ground truth" for a display device would primarily relate to its technical specifications (e.g., resolution, brightness, contrast, color accuracy) and its ability to accurately render images as intended by the source, rather than a clinical ground truth like pathology or outcomes data.
8. Sample Size for Training Set
Not applicable. This is a hardware device; it does not have a "training set" in the context of machine learning.
9. How Ground Truth for Training Set Was Established
Not applicable.
§ 892.2020 Medical image communications device.
(a)
Identification. A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.