(43 days)
IVUS Plus is a digital image processing accessory to Boston Scientific's intravascular ultrasound imaging systems, ClearView (K891386) and Insight (K921750). It adds fulllength longitudinal digital display capability, full image rotation capability, and mensuration functions. It is indicated for use in patients who are candidates for transluminal interventional procedures such as angioplasty and atherectomy
The provided document is a 510(k) summary and FDA clearance letter for a device called "IVUS Plus." This device is described as a digital image processing accessory for intravascular ultrasound imaging systems, adding features like full-length longitudinal digital display, image rotation, and mensuration functions.
However, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or performance metrics. The FDA clearance is based on substantial equivalence to predicate devices, meaning it has a similar intended use, design, and operational characteristics to previously approved devices, not necessarily a new clinical study demonstrating specific performance metrics against pre-defined acceptance criteria.
Therefore, I cannot provide the requested information from the given text. The provided document is a regulatory approval, not a scientific study report.
§ 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).