(28 days)
The MDMC-12133 is intended to be used in displaying digital images, including standard and multi-frame digital mammography, for review, analysis and diagnosis by trained medical practitioners. It is especially designed for breast tomosynthesis applications.
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The provided text is a 510(k) premarket notification letter from the FDA to BARCO N.V. concerning their device MDMC-12133, a Picture Archiving and Communications System (PACS). The letter indicates that the device is intended for displaying digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis, with a special design for breast tomosynthesis applications.
However, the document is an FDA approval letter and does not contain the detailed study information necessary to answer your specific questions regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study methodologies. The letter confirms substantial equivalence to a predicate device and states the intended uses but does not include the underlying technical or clinical validation studies.
Therefore, I cannot provide the requested information based solely on this document. To answer your questions, additional documentation such as the 510(k) submission summary, a clinical study report, or a detailed technical specification document would be required.
§ 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).