(118 days)
Change Healthcare Enterprise Viewer is a software-based enterprise viewer intended to be used with off-the-shelf hardware for the 2D and 3D display of DICOM and non-DICOM medical images, reports, and multimedia content. Change Healthcare Enterprise Viewer is intended as well to facilitate collaboration and sharing of these materials within and outside the healthcare enterprise.
Change Healthcare Enterprise Viewer is intended to enable trained healthcare professionals to perform a diagnostic review on a workstation and non-diagnostic review on a mobile device, of a patient's medical images and to aid their clinical decision-making process.
Users access the application on a desktop computer or specific mobile devices through a standard web browser.
Change Healthcare Enterprise Viewer is not intended for diagnostic use on a mobile device. When used on a mobile device, Change Healthcare Enterprise Viewer is not intended to replace full workstations and should only be used when there is no access to a workstation.
Change Healthcare Enterprise Viewer is not intended for primary mammography diagnosis.
Change Healthcare Enterprise Viewer is an enterprise medical image viewer software application used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D & 3D display of DICOM and non-DICOM medical images, reports, and multimedia content.
Change Healthcare Enterprise Viewer is intended to connect to an existing Picture Archiving and Communication System (PACS) or Vendor Neutral Archive (VNA) and is used to display medical images of multiple for clinical review, sharing and collaboration purposes.
The provided document is a 510(k) summary for the Change Healthcare Enterprise Viewer. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, detailed study designs, or performance metrics in the way requested in the prompt.
Specifically, the document states: "No clinical studies were necessary to support substantial equivalence." This means that the information requested regarding test sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and detailed sample sizes for training/test sets is not present because such studies were not conducted or submitted for this particular 510(k) clearance. The clearance was based on demonstrating substantial equivalence through technological characteristics and intended use alignment with a predicate device, rather than a performance study meeting specific acceptance criteria.
Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, nor can I provide information about the study design elements such as sample sizes, expert qualifications, or adjudication methods, as this information is not included in the provided 510(k) summary.
§ 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).