(83 days)
UniPACS Workstation software is intended to be used as a fully-functional, PCbased PACS software application, to review, interpret, manipulate, network, print and visualize medical multi-modality image data in DICOM format. When interpreted by a trained physician, reviewed images can be used as an element for diagnosis.
The UniPACS Workstation is a Windows-based software application acting as stand alone Picture Archiving and Communications System (PACS). It may be marketed as software only, as well as packaged with standard "off-the-shelf" PC hardware.
The comprehensive set of tools provided in this software allows the physician to review, interpret, manipulate, print and visualize medical image data stored in DICOM format. The networking component of the product allows the physician to exchange image data with any other DICOM-compatible or FTP-compatible server over a standard TCP/IP network. The web component of the product displays workstation images in the web-browser interface, for remote review and reporting.
The device does not contain the patient, nor does it control any life sustaining devices.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics. This K023476 submission for the UniPACS Workstation is primarily focused on demonstrating substantial equivalence to a predicate device (eFilm Workstation K012211) through a comparison of features and intended use, rather than presenting a performance study with defined acceptance criteria.
The information given highlights that both UniPACS and eFilm are software programs for DICOM image manipulation on PCs, offering similar image processing, storage, and networking functionalities. The conclusion is that UniPACS offers equivalent functionality to the predicate device.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details from the provided document.
§ 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).