(90 days)
PatXfer provides capabilities for the acceptance, transfer, display, storage and digital processing of medical images including functions for performing operations related to image manipulation, enhancement, compression and quantification.
PatXfer intends to interface between medical devices and provide the patient data for treatment plan. The application provides capabilities for the transfer, display, storage and digital images. PatXfer supports scanner specific and standard data formats from digital storage media, such as network archive, optical disk, tape, CD-ROM or hardcopy. To facilitate the imaging and communication with other medical systems the DICOM format and protocol is supported.
To keep the application as user-friendly as possible only the necessary information for the intended procedures are displayed. The patient, image series and images will be displayed and can be selected and processed. PatXfer creates a history log-file including all the software actions to import the data and can be controlled with the mouse or by touch screen monitor.
This document does not contain information regarding acceptance criteria, device performance, or specific studies with sample sizes, expert involvement, or adjudication methods.
The provided text is a 510(k) summary and an FDA clearance letter for a device called "PatXfer." It describes the device's intended use (Picture Archiving and Communication System functions like acceptance, transfer, display, storage, and processing of medical images) and states that its substantial equivalence was proven through "validation according to BrainLAB's procedures for product design and development."
Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence to a predicate device rather than detailed performance study results against predefined acceptance criteria.
§ 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).