The Pre-Sure patient modeling system is a method for the creation of patient models. Importantly, and unlike other 3D modeling systems, in the Pre-Sure process the design and production of patient models is performed by Lazarus 3D or its affiliates (with physician input), and not by the End User.The Pre-Sure software process is FDA cleared for the analysis of patient radiological data to create a digital patient design, referred to as a “Digital Twin”. Digital Twins can be used by End Users, when viewed in an appropriately cleared viewing program, for a variety of uses including training, education, and surgical planning.Patient specific Digital Twins may be further used as an input to a 3D printing-based production process performed by Lazarus 3D. This process creates physical patient models, referred to as Pre-Sure models. Each individual patient’s model can be created rapidly from the patient’s radiological data. The resulting physical models of patient anatomy are primarily composed of silicone materials that can be cut, can be sutured, and in some cases can even bleed, and of hard plastic materials that can be sawed, drilled, and can accept screws.End Users of the Preoperative Surgical Rehearsal (Pre-Sure) device receive digital and/or physical patient anatomical models from Lazarus 3D. Digital models may be viewed by End Users using any program cleared for their intended use. The physical models are intended for adjunctive use along with other diagnostic tools and expert clinical judgment for diagnosis, patient management, and/or treatment selection for genitourinary, cardiovascular, craniofacial, gastrointestinal, neurological, musculoskeletal, respiratory, and pediatric applications.
An application software program, routines, and/or algorithms used as or in a radiology information system (RIS) to electronically receive, collect, store, manage, assist in analysis of, display, output, and distribute data, within/between facilites, to support the administrative and clinical activities associated with the provision and utilization of radiology services and facilities. It may be used for patient scheduling and work-list generation for specific radiological systems; it may be used in conjunction with PACS and include various technology imaging modalities. It is installed into a dedicated radiology information system or existing mainframe or decentralized computers/network.