(52 days)
Philips Inturis Suite is intended to be used for the display and reading of cardiac angiographic images stored on a compact disk (CD) or an image server. Inturis Suite also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.
Philips Inturis Suite is software comprised of modular software programs designed to perform the necessary functions required for the import, storage, archive, review, analysis, reporting and database management of digital cardiovascular angiographic images in DICOM 3.0 formats within and beyond the Cath Lab domain. Inturis Suite allows multiple users to quickly access and transfer multiple angiographic exams. Inturis Suite software can be installed and run on Windows NT based personnel computers for small applications and on UNIX based servers for high performance applications. The modular software design of Inturis Suite, allows users to tailor their image archive, transfer and communication requirements based on their particular performance needs and the number of cath labs importing images to an Inturis Suite via DICOM. Inturis Suite software will be provided on a CD-Rom which contains the installation program, the applicable executable files, DLL files and a readme file.
The provided document does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) summary for the Philips Inturis Suite, an image review software for angiographic X-ray systems. It primarily focuses on demonstrating substantial equivalence to a predicate device (ImageView Coronary Angiography Display and Review System by HeartWare, Inc.) by comparing technological characteristics and stating the intended use.
Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details. This information is typically found in performance studies, which are not present in this regulatory submission.
§ 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).