(85 days)
The X-Sight device is indicated for reading, storing, and converting image data from fluoroscopic x-ray systems.
X-Sight Medical Digital Imaging System
The provided document is a 510(k) clearance letter from the FDA for the X-Sight Digital Imaging System. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or results of MRMC or standalone studies.
The content is limited to the regulatory clearance of the device for marketing. Therefore, I cannot extract the requested information about acceptance criteria and the study proving the device meets them from the provided text.
§ 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).