(90 days)
MACOM ™ performs real-time digital image enhancement of screen/film mammograms.
MACOM™ Image Processing System
The provided text is a 510(k) clearance letter from the FDA for the MACOM™ Image Processing System and its Indications for Use statement. It does not contain any information about acceptance criteria, study design, or performance metrics.
Therefore, I cannot answer your request based on the provided input. To describe the acceptance criteria and the study that proves the device meets them, you would need documentation such as a clinical study report, a validation report, or the 510(k) summary which often includes performance data.
§ 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).