(71 days)
The Coronis Fusion 4MP DL (MDCC-4130) is intended to be used in displaying and viewing digital images, for review and analysis by trained medical practitioners. These devices must not be used in primary image diagnosis in mammography.
Not Found
This document is a 510(k) clearance letter for the Barco Coronis Fusion 4MP DL (MDCC-4130) display device. It is a regulatory approval, not a study report. Therefore, it does not contain the information requested about acceptance criteria and a study proving device performance in the context of an AI/algorithm-based medical device.
The requested information pertains to studies typically performed for AI/ML-driven medical devices to demonstrate their diagnostic performance. This document, however, is for a display device (a monitor) and its clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on its ability to display digital images for review.
Therefore, I cannot extract the requested information as it is not present in the provided text.
To provide an answer to your request, I would need a different type of document, such as a clinical study report or a 510(k) submission summary for an AI/algorithm device that analyzes medical images.
§ 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).