(62 days)
XR-EXpress is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. XR-EXpress is for hospitals, imaging centers, nursing homes, radiologist reading practices, and any user who requires and is granted access to patient image, demographic, and report information.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
The XR-EXpress system is comprised of a capture component (XR-EXpress Capture), a central server component (XR-EXpress Server), and a viewer component (XR-EXpress Viewer) that is used on general purpose computing hardware. Patient information, procedure information, and image acquisition data is captured by XR-EXpress Capture and sent to the XR-EXpress server or alternatively, it is accepted directly from a DICOM compliant device. After receiving image objects and associated data, the XR-EXpress server registers the incoming data and images with the archive including any associations with prior cases. The cases are presented to users with the correct permissions from a work list as controlled by a managing user. The image data is transmitted and rendered on the users workstation using a standard web browser for management views or the XR-EXpress Viewer for diagnosis. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the dictation and transcribe it to text. Once the XR-EXpress Server registers a report, the report is available to the referring physician or client service where it available electronically or via fax.
The provided text is a 510(k) summary for the XR-EXpress system, which is a Picture Archiving Communications System (PACS) and teleradiology system. It describes the device's intended use and technical characteristics but does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical data, clinical trials, or validation studies with performance metrics like sensitivity, specificity, or reader agreement.
The document states: "New Mexico Software has conducted extensive validation testing of the XR-EX System, as a PACS system that is capable of providing reliable teleradiology services over the Internet. All of the different components of the XR-EX system have been stress tested to ensure that the system as a whole provides all the capabilities necessary to operate safely and effectively."
This general statement about "validation testing" and "stress testing" does not include the specific details required to answer your questions regarding acceptance criteria and performance data. The 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance study results.
Therefore, I cannot provide the requested information.
§ 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).