DESCRIPTION
These instructions are intended for the Operating Surgeon and supporting Healthcare Professionals. The US instructions are intended for users in the United States and its territories. Rx only ADS Diagnostic Models are virtual and additive manufactured anatomic models intended to make a diagnosis during maxillofacial surgery planning. The models are created from a CT scan of the patient’s anatomy, which is segmented through CommercialOff-The-Shelf (COTS) software and converted into virtual 3D models. The surgeon uses these 3D models to make the initial plan/diagnosis based on examination or physical measurement of the patient´s anatomy, this includes planning anatomic structures movements (for example, maxilla and mandible movements for occlusion), the resections, measurement of anatomic distances (e.g., the facial symmetry), and determining fixation points and the size and shape of the implants if requested. These functions are those that the surgeon can perform, not functions that the subject device provides by itself. Acumed creates a design proposal for the case based on the information given by the medical professional and the process continues until the final design proposal is approved. Finally, the digital file can be used as an input to produce physical anatomic models through additive manufacturing.

INDICATIONS FOR USE
The ADS Diagnostic Models are patient-specific devices intended to be used as a pre-operative planning tool for treatment in the field of maxillofacial surgery. The input data file (DICOM imaging information from a medical scanner file) is processed by commercial offthe-shelf software, and the result is an output data file that may then be provided as digital models or used as input to produce physical anatomic models using additive manufacturing. The physical replica can be used for diagnostic purposes in the field of maxillofacial applications. ADS Diagnostic Models should be used in conjunction with other diagnostic tools and expert clinical judgment. ADS Diagnostic Models are not intended to enter the operating room. ADS Diagnostic Models are indicated for adults (People over the age of 21).