(109 days)
Will3D is a software application used for the display and 3D visualization of medical image files from scanning devices, such as Dental CT scanner. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, store, print, assist in diagnosis, and distribute images utilizing standard PC hardware. Additionally, Will3D is a preoperative software application used for the simulation and evaluation of dental implants, orthodontic planning and surgical treatments.
The Will3D is one of the components of a PACS (Picture Archiving and Communications System). The Will3D is the software application that provides image viewing and manipulation in the diagnostic imaging setting.
The provided document is a 510(k) premarket notification for the medical device "Will3D," a software application for dental imaging. It outlines the device's intended use, technological characteristics, and comparison to predicate devices to establish substantial equivalence.
However, the document states: "No clinical studies were considered necessary and performed."
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be provided from this document because no clinical studies were conducted to prove the device meets acceptance criteria derived from such studies. The equivalence is established purely on technological characteristics and intended use compared to predicate devices.
§ 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).