(206 days)
The DICOM Theater device is Intended to be used as a tool in displaying and viewing digital images (excluding digital mammography) for review and analysis by trained medical practitioners.
The DICOM Theater device is a digital image display system. The DICOM Theater consists of components to provide high resolution visualization of digital images.
The provided text is a 510(k) summary for the Barco NV DICOM Theater device, a digital image display system. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device (Coronis 1MP Medical Flat Panel Display System, K023340).
The document does not contain information regarding specific acceptance criteria, a study that proves the device meets those criteria, or details regarding ground truth establishment, sample sizes, or expert qualifications for a performance study. It merely states the device's intended use and technological characteristics.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using the information provided. The document outlines the regulatory process and approval of the device, but not the technical performance study details that would be required to answer your questions.
§ 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).