(78 days)
The Access Radiology "Framewave Web" Image and Information System is indicated for the display and management of radiologic images and associated information stored and transmitted in both compressed and uncompressed form.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Framewave™ Web" dated December 15, 1998. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, device performance, details of a study (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or how ground truth was established for training or testing sets. The letter is a regulatory approval, not a scientific study report.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document only confirms the device's regulatory classification and permissibility to market.
§ 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).