(50 days)
Visio+ CD Viewer is a software component that is used for viewing medical images stored on a CD-ROM. This software is not meant for primary image interpretation in mammography.
Visio+ CD Viewer is located on the CD-ROM with the medical images. Visio+ CD Viewer provides tools for image review and manipulation which can only be used with the medical images present on the CD-ROM.
Typical users of Visio+ CD Viewer are trained professionals, including physicians and radiologists.
Visio+ CD Viewer is a component software which must be burned on a CD-ROM with medical images by another Medical Device.
Visio+ CD Viewer operates only on a computer that meets the following requirements: Windows 2000/XP, Pentium III 1 GHz or better, 512 Mo RAM, minimum display resolution 1024x768, a CD or DVD drive. Visio+ CD Viewer provides tools for image review and manipulation.
This submission describes the Visio+ CD Viewer, a software component designed for viewing medical images stored on a CD-ROM. The document mentions "Testing: Visio+ CD Viewer is tested according to the specifications that are documented in a Software Test Plan. Performance and functional testing are an integral part of Keosys's software development process." However, it does not provide details of specific acceptance criteria, studies, or performance results. Therefore, I cannot generate the requested table or answer most of the questions as the information is not present in the provided text.
Based on the provided text, the following information can be extracted:
7. The type of ground truth used:
Not specified, but functional and performance testing are mentioned.
8. The sample size for the training set:
Not specified, as this device is a viewer and not an AI/ML algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable, as this device is a viewer and not an AI/ML algorithm requiring a training set in the conventional sense.
§ 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).