(78 days)
Triana is intended for use as a software package which obtains medical images from CT, Cephalometric / Panoramic X-ray system & etc., stores those and provides 3D visualization, 2D analysis, various MPR(Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
Triana is a computer based dental imaging software which obtains medical images taken from CT, Cephalometric / Panoramic X-ray system & etc. and provides 3D visualization and 2D analysis, various MPR (Multi-Planar Reconstruction) functions for further rapid and precise diagnosis.
Triana is designed to provide users easy and familiar user-interface. Also Triana makes it possible to manage medical images more easily and provides advanced tools for 2D and 3D analysis with rendering functions.
The provided text describes a 510(k) submission for a Picture Archiving and Communications System (PACS) called Triana. However, it does not contain any information regarding specific acceptance criteria, a study proving device performance against those criteria, or details about sample sizes, expert qualifications, or ground truth establishment.
The submission focuses on establishing substantial equivalence to a predicate device (CyberMed, Inc.'s OnDemand3D K070464). The text explicitly states:
"The result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate devices."
This statement implies that some form of evaluation was performed, but no details of such evaluation (e.g., acceptance criteria, detailed study results, methodologies) are provided in the given document excerpts.
Therefore, I cannot populate the requested table and answer the questions based on the input.
Key takeaway: The provided document is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device based on similar functions and characteristics, rather than a detailed report of a study with specific acceptance criteria and performance metrics.
§ 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).