(43 days)
Siemens syngo MBF is a software product intended for visualization, assessment and quantification of PET images.
The application performs quantitative measurements of tracer uptake over time to aid in the interpretation of myocardial perfusion PET images.
The product is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual comparison of the information.
syngo MBF is a software only product intended for visualization, assessment and quantification of medical images: specifically providing quantitative blood flow measurements of PET images. The application supports dynamic Rubidium – PET and dynamic Ammonia - PET images.
The application provides visualization and measurement tools, for qualitative and quantitative visualization and assessment of the input data. It provides automatic and manual tools to orient and segment the myocardium. The software calculates measurements of myocardial blood flow, and provides tools, for the Clinician to assess these results. The user may save the results.
The application is intended for use by trained professionals. The Clinician retains the ultimate responsibility for making the pertinent assessment based on their standard practices and visual assessment of the myocardial perfusion PET images. The quantitative assessment is to be used in conjunction with traditional visual assessment of myocardial perfusion PET images for the assessment of coronary artery disease, and quantitatively by comparing to a database.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them. The document is a 510(k) summary for syngo MBF, focusing on its substantial equivalence to a predicate device and its intended use. It describes the software's function (visualization, assessment, and quantification of PET images, specifically for myocardial blood flow), but it does not include performance metrics or a study designed to evaluate them against predefined acceptance criteria.
Therefore, I cannot populate the requested table or answer the specific questions about sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.
The closest information available is the general statement on "Safety and Effectiveness" which mentions risk management:
"Risk Management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product." This indicates a risk analysis was performed, but it doesn't quantify or specify acceptance criteria for the device's diagnostic performance.
§ 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).