(30 days)
Stentors' iSite Radiology is a medical image softcopy reading software package to be used for display of digital radiology images.
iSite Radiology is designed as a Diagnostic reading workstation. iSite Radiology is capable of receiving and displaying DICOM images. Images sent to ISite Radiology are converted into formats suitable for viewing in its framework, and stored in a local cache. ISite Radiology is used by ISite Radiology to view JPEG and wavelet images follow known and accepted protocols. Images sent to ISite Radiology can be viewed using an executable that is installed on a Personal Computer equipped with the appropriate hardware. ISite Radiology uses standard "off-the-shelf" PC hardware and communicates using the standard TCP/IP stack.
The provided text is a 510(k) summary for the Stentor iSite Radiology software, specifically focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.
The document primarily states that the iSite Radiology software is "designed, developed, tested and validated according to written procedures" and that "Extensive testing of the software package has been performed by programmers, by non-programmers, quality control staff, and by potential customers." However, it does not detail the nature, outcome, or specific metrics of these tests.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided text. The document is a regulatory submission focused on demonstrating substantial equivalence, not a detailed technical report of performance testing.
§ 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).