(14 days)
The Coronis 5MP Mammo SL (MDMG 6121) Display is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners.
Not Found
This FDA 510(k) clearance letter for the Barco Coronis 5MP Mammo SL states that the device is intended for displaying and viewing digital images, including digital mammography, for review and analysis by trained medical practitioners. However, the provided document does not contain information about the acceptance criteria or a study proving the device meets those criteria.
The letter is a regulatory filing indicating substantial equivalence to a predicate device, which means it met the administrative requirements for marketing. It does not include performance data, study design, or any of the detailed information requested in the prompt regarding acceptance criteria and performance studies.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment based on the provided text.
§ 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).