(184 days)
The MediCal Administrator device is intended to be used as a tool for trained medical practitioners to manage total image softcopy quality from a central location.
The MediCal Administrator device is a digital image quality management system
The provided text is a 510(k) summary for the Barco MediCal Administrator, a digital image quality management system. It contains information about the device's intended use and classification, but it does not include any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document merely states that the device is substantially equivalent to a legally marketed predicate device (K982690) and clears it for marketing.
§ 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).