(87 days)
The Molecular Breast Imaging Software is designed to acquire nuclear medicine image data from the Gamma Medica-Ideas LumaGEM™ gamma camera systems. The Molecular Breast Imaging Software allows images and data to be stored, communicated, processed, analyzed and displayed on a compatible workstation.
The Gamma Medica-Ideas Molecular Breast Imaging Software ("MBI Software") is a software tool intended to display and process breast images captured with the Gamma Medica-Ideas LumaGEM" gamma camera systems. The MBI Software contains functions of study display, Gray and Inverse Gray Images, Window/Level changes, Measuring Tool, image processing, and Save, Sum, and Reload (both raw and processed). Image processing is based on pixel-by-pixel analysis and algorithmic filters applications. The MBI Software application supports simultaneous display of multiple images, allowing the user to visualize several angles of the imaged breast tissue at once. The MBI Software is compatible with DICOM and other formats.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily describes a 510(k) premarket notification for the Molecular Breast Imaging Software, focusing on its intended use, product description, and substantial equivalence to predicate devices. The "Testing in Support of Substantial Equivalence Determination" section only broadly mentions "Software verification and validation" and "Direct comparison testing between the subject device and the original application" without providing any specific criteria, methods, or results of these tests.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.
Key takeaway from the provided text: The submission relies on demonstrating substantial equivalence to predicate devices, and the "testing" mentioned is not detailed enough to provide the requested information.
§ 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).