(64 days)
The Barco MediCal Display Conformity and Consistency Software device is intended to be used as a tool in displaying and viewing digital images for review and analysis by trained medical practitioners.
The MediCal device is image consistency and calibration software package.
I am sorry, but the provided text does not contain information about acceptance criteria, device performance, test study details (sample size, data provenance, expert qualifications, adjudication methods), multi-reader multi-case studies, standalone algorithm performance, ground truth types, or training set specifics. The document is a 510(k) summary for a medical device called "Barco MediCal Display Conformity and Consistency Software," which is image consistency and calibration software. It describes the manufacturer, contact information, classification, intended use, and technological characteristics, as well as the FDA's clearance letter. However, it lacks the detailed performance study information you've requested.
§ 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).