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InVivoDental is intended for use as a front-end software interface for the transfer of imaging information from a medical scanner such as a Dental CT scanner. It is also intended for use as a planning and simulation software in the placement of dental implants, orthodontics and surgical treatment

InVivoDental is a volumetric imaging software designed specifically for dental clinicians. The software reads DICOM data from dental CT machines including I-CAT, NewTom, MecuRay and Accuitomo. The software runs in Windows XP operating system and visualizes the DICOM data on the computer screen. The software is downloaded over the internet and installed on the customer's computer.

The provided text does not contain details about specific acceptance criteria or a study proving device performance against those criteria. It is a 510(k) summary indicating that the device is substantially equivalent to predicate devices based on its intended use, product, performance, and software information. The only mention of testing is a general statement: "Results of in-vitro testing demonstrate that the InVivoDental is safe and effective for its intended use."

Therefore, I cannot provide the requested information in the structured format you provided. The document lacks the detailed performance study data, sample sizes, ground truth establishment, or expert involvement that your questions inquire about.

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