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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.

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