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Avatar Medical Vision is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi-dimensional digital images on a standard (non-stereoscopic) screen in the operating room, and on an autostereoscopic screen or VR headset in a non-sterile room. Avatar Medical Vision is designed for use by healthcare professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Avatar Medical Vision is a software-only device that allows medical professionals to review CT and MR image data in three-dimensional (3D) format on a standard (non-stereoscopic) or autostereoscopic computer screen and/or in virtual reality (VR) interface. The 3D and VR images are accessible through the software desktop application, on a standard (non-stereoscopic) or autostereoscopic computer screen, and, if desired, through compatible VR headsets. Images are used by users for preoperative surgical planning and for display during intervention/surgery.

The Avatar Medical Vision product is to be used to assist in medical image review. Intended users are medical professionals, including imaging technicians, clinicians and surgeons.

Avatar Medical Vision includes three main software-based user interface components:

• the Splash Screen Interface (includes DICOM query),
• the Desktop Interface (includes 2D Interface, 3D Interface, and Autostereoscopic Interface),
• the VR Interface.

The Splash Screen Interface and Desktop Interface run on a compatible off-the-shelf (OTS) workstation provided by the hospital and only accessed by authorized personnel.

The Splash Screen Interface contains a graphical user interface where a user can retrieve DICOM-compatible medical images locally or from a Picture Archiving Communication System (PACS) or DICOM Server. Upon loading a DICOM series, the user is presented with the main Desktop Interface, which itself comprises a 2D and 3D Interface, with the option of switching to the VR and Autostereoscopic dedicated Interfaces. Users are able to make measurements, annotations, and apply fixed and manual image filters. Additionally, the Desktop Interface can be accessed through the Avatar Hub, a streaming service that allows users to securely access their remote computer where Avatar Medical Vision is installed.

The Autostereoscopic Interface is accessible via a compatible autostereoscopic display to allow users to review the medical images in a 3D autostereoscopic format. This interface is shown in the Desktop Interface. This 3D autostereoscopic format can be viewed only when the user connects a compatible autostereoscopic screen directly to the workstation being used to view the Desktop Interface. Avatar Medical Vision's autostereoscopic mode is compatible solely with the following autostereoscopic monitor:

• Barco Eonis 3D MDRC-8127

The VR Interface is accessible via a compatible OTS headset to allow users to review the medical images in a VR format. VR formats can be viewed only when the user connects a compatible VR headset directly to the workstation being used to view the Desktop Interface. Avatar Medical Vision's virtual reality (VR) mode is compatible solely with the following VR headsets:

• HTC Vive XR Elite
• Meta Quest 3

The 3D images generated using Avatar Medical Vision are intended to be used in relation to surgical procedures in which CT or MR images are used for preoperative planning and/or during intervention/surgery.

The intraoperative use of Avatar Medical Vision solely corresponds to the two following cases:

• Display of the Avatar Medical Vision Desktop Interface on existing standard (non-stereoscopic) monitors/screens in the operating room. The autostereoscopic screen is not intended for installation in the operating room to display Avatar Medical Vision.
• Use in a non-sterile image review room accessible from the operating room during the procedure (Avatar Medical Vision operates on VR headsets and on autostereoscopic screen, which are not approved to be used in the sterile environment of the operating room).

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