(33 days)
The KODAK CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive/distribute/retrieve and display images and data from all hospital modalities and information systems.
Not Found
The provided document is a 510(k) clearance letter for the "Kodak Carestream PACS" device. This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.
However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The 510(k) clearance process primarily focuses on demonstrating substantial equivalence to a predicate device, which often relies on comparison of technical characteristics and intended use, rather than extensive new clinical performance studies. While some performance testing is implied for regulatory submission, the details of such testing are not included in this particular FDA letter.
Therefore, I cannot provide the requested information from the given text. A complete description of acceptance criteria, study details, and performance metrics would typically be found in the manufacturer's 510(k) submission itself, not in the FDA's clearance letter.
§ 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).