(79 days)
cvi42 vascular analysis add-on is an image analysis software package add-on for evaluating CT and MR images of blood vessels. Combining digital image processing and visualization tools such as multiplaner reconstruction (MPR), thin/think maximum intensity projection (MIP) thin and think, inverted MIP thin and think, volume rendering technique (VRT), curved planner reformation, processing tools such as bone removal (based on both single energy and dual energy) table removal and evaluation tools (vessel centerline calculation, lumen calculation, stenosis calculation) and reporting tools (lesion location, lesion characteristics) and key images), the software package is designed to support the physician in conforming the presence or absence of physician identified lesion in blood vessels and evaluation, documentation and follow up of any such lesions.
It shall be used by qualified medical professionals, experienced in examining and evaluating cardiovascular CT or MR images, for the purpose of obtaining diagnostic information as part of a comprehensive diagnostic decision-making process. cvi42 is a software application that can be used as a stand-alone product or in a networked environment.
The target population for the cvi42 is not restricted, however the image acquisition by a cardiac CT or MR scanner may limit the use of the device for certain sectors of the general public.
cvi42 vascular add-on is software application for evaluating cardiovascular images in a DICOM Standard format. The software can be used as a stand-alone product that can be integrated into a hospital or private practice environment. cvi42 has a graphical user interface which allows users to qualitatively and quantitatively analyze cardiac CT & MR images.
The provided text describes the cvi42 device, an image analysis software for CT and MR images of blood vessels, but it does not contain the detailed acceptance criteria or the study results that specifically prove the device meets those criteria.
The document states that "cvi42 have been tested according to the specifications that are documented in a Master Software Test Plan," and that "The successful non-clinical testing demonstrates the safety and effectiveness of the cvi42 when used for the defined indications for use and demonstrates that the device for which the 510(k) is submitted performs as well as or better than the legally marketed predicate device." However, it does not provide the specifics of these tests, acceptance criteria, or performance metrics.
Therefore, I cannot fill out the requested table or answer the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement based on the provided text.
The information related to the predicate device "iNtuition (K121916)" is largely for functional comparison, showing both devices have similar capabilities, but it does not present performance data for either the predicate or the cvi42 device.
§ 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).