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The VAULT® System is intended for use as a software interface and image manipulation system for the transfer of imaging information from a medical scanner such as Computerized Axial Tomography (CT) or Magnetic Resonance Imaging (MRI). It is also intended as pre-operative software for simulating/evaluating implant placement and surgical treatment options. The physician chooses the out-put data file for printing and/or subsequent use in CAD modeling or CNC/Rapid-prototyping.

The VAULT® System software described here was developed in conformance with reference to the FDA Guidance Document for Industry "Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, July 27, 2000". Based on the information contained in Section G of that document, a final determination of submission content was developed. A secondary reference entitled "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. May 11, 2005 was also used and resulted in a determination of a "MODERATE" level of concern for the software. The UAULT® System software is made available to the user via a web-accessed software interface. The program is a surgeon directed surgical planning package primarily but not exclusively directed at trauma and orthopedic indications. After secure log-in the user requests, creates, reviews and finally authorizes their desired surgical plan. When authorizing, the surgeon/user may choose additional options such as implant sizing and/or various file output options.