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InVivo Web Viewer is a software application used for the display and 3D visualization of medical image files from scanning devices, such as CT and MRI. It is intended for use by radiologists, clinicians, referring physicians and other qualified individuals to retrieve, process, render, review, assist in diagnosis, utilizing web user interface. Additionally, InVivo Web Viewer is a preoperative software application used for the planning and evaluation of dental implants and surgical treatments. This device is not indicated for mammography use.

InVivo Web Viewer is an imaging software designed specifically for clinicians, doctors, physicians and other qualified medical professionals. It is used for the visualization of patient image files from scanning devices, such as CT and MRI, and for assisting in case diagnosis, dental implant placement and treatment planning. It displays 2D image and renders 3D volumetric image in web browser environment such as Google Chrome or Mozilla Firefox. Users are able to examine anatomy on a computer screen and manipulate the rendered image by turning, zooming, clipping, adjusting brightness and contrast and choosing different rendering color presets. User can also make distance measurements on the image and use the implant placement tool for assisting implant placement and surgical treatment planning.

The provided text describes a 510(k) submission for the "InVivo Web Viewer" and compares it to a predicate device, "InVivoDental." However, the document does not contain any information about acceptance criteria, device performance metrics, specific study results (like sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment details, or details about expert involvement for establishing ground truth or adjudicating cases.

The "Non-Clinical Test Results" section vaguely mentions "Performance testing" and "Bench testing of the software with predicate software," stating "This testing confirms that InVivo Web Viewer is as effective as its predicate in its ability to perform essential functions." This statement, however, lacks any quantitative performance data.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the provided information. The document focuses on regulatory equivalence based on intended use and technological characteristics rather than detailed performance study results against specific criteria.

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