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The Medical Modeling VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as CT based system. The is processed by the VSP® System and the result is an output data file that may then be provided as digital models or used as ingut to a rapid prototyping portion of the system that produces physical outputs including and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating surgical reatment options.

The Medical Modeling VSP® System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support orthognathic or reconstructive surgery. The system uses electronic medical images of the patient's anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The system manipulate enginal patient specific outputs including, anatomical models (physical and digital), surgical templates / guides, splints, and patient specific case reports. Following the Medical Modeling Quality System and specific Work Instructions, trained employees utilize a combination of Commercial Off-The-Shelf (COTS) and trantom software to manipulate 3D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), 3D scan images from patient physical models (stone models of the patient's teeth), and / or standard (non-bent) or priyered model implant files to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and process telivery of the final outputs. While the process and data-flow can vary and phor to activery of the particular requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, following doben pour can be the defined system outputs. It should be noted that the system is operated only by trained Medical Modeling employees, and the the oyotan to open area the information. The physician only provides input for priysioian doos not anothy mactive feedback through viewing of digital models of model mempulation are modified by the engineer during the planning session. The VSP® System is made up of 14 individual pieces of software and additional manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical templates / guides and patient-specific case reports for (priyalour and digital), bargham, burgical region. Surgical guides for graft bone harvesting from patient bone such as, but not limited to, the fibula and hip, are also produced by the system. The VSP® System requires an input 3D image file from medical imaging systems (i.e. CT) and / or a standard or patient contoured implant file. This input is then used, (i.e. ST) and from the prescribing physician to provide the following categories of with ourport reconstructive surgery. Each system output is designed with outpute to oupper roosiewed by the physician prior to finalization and distribution. priysician input, and foviotity direct physician involvement to reduce the criticality of the outputs.

The Medical Modeling VSP® System is intended for use as a software system and image segmentation system for the transfer of imaging information from a medical scanner such as a CT based system. The input data file is processed by the VSP® System and the result is an output data file that may then be provided as digital models or used as input to a rapid prototyping portion of the system that produces physical outputs including anatomical models, templates, and surgical guides for use in maxillofacial surgery. The VSP® System is also intended as a pre-operative software tool for simulating / evaluating surgical treatment options.

The Medical Modeling VSP® System is a collection of software and associated additive manufacturing (rapid prototyping) equipment intended to provide a variety of outputs to support reconstructive surgery. The system uses electronic medical images of the patients' anatomy with input from the physician, to manipulate original patient images for planning and executing surgery. The system produces a variety of patient specific outputs including; anatomical models (physical and digital), surgical templates / guides, splints, and patient specific case reports. Following the Medical Modeling Quality System and specific Work Instructions, trained employees utilize a combination of Commercial Off-The-Shelf (COTS) and custom software to manipulate 3-D medical scan images which can include Computed Tomography (CT), Cone Beam CT (CBCT), and/or 3-D scan images from patient physical models (stone models of the patient's teeth) to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and prior to delivery of the final outputs. While the process and dataflow vary somewhat based on the particular requirements of a given patient and physician, the following description outlines the functions of key sub-components of the system, and how they interact to produce the defined system outputs. It should be noted that the system is operated only by trained Medical Modeling employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session. The VSP® System is made up of 13 individual pieces of software and 9 pieces of manufacturing equipment integrated to provide a range of anatomical models (physical and digital), surgical guides, and patient specific planning reports for reconstructive surgery in the maxillofacial region. Surgical guides for graft bone harvesting which can include the fibula and hip are also produced by the system. The VSP® System requires an input 3-D image file from medical imaging systems (i.e. CT). This input is then used, with support from the prescribing physician to provide the following potential outputs to support reconstructive surgery. Each system output is designed with physician input, and reviewed by the physician prior to finalization. All outputs are used only with direct physician involvement reducing the criticality of the outputs. System Outputs: Anatomical Models Surgical Positioning Templates / Guides Osteotomy Templates / Guides Plate Bending Templates/Guides Patient Specific Case Reports The VSP® System also contains a set of Stainless Steel Cutting and Drill Inserts (VSP® System Accessories) which are intended to be used by the physician to guide cutting and drilling activities during the surgical procedure. The inserts fit into a standard slot/hole in the cutting/drill guides, and can be used across all the VSP® System guides and templates.