DESCRIPTION
The ADS CMF Guides are indicated as a pre-operative tool to support the diagnostic and treatment planning process of maxillofacial procedures by providing surgical guides and splints. ADS CMF Guides are Patient-Specific single-use devices designed to assist surgeons in transferring the presurgical plan to the operation room. This system includes surgical guides intended for Orthognathic and Reconstructive surgeries in adults. The surgical guides have drilling holes and slots to make osteotomies and ensure the correct positioning of bones and implants. The ADS CMF Guides are divided into two categories: ADS Orthognathic Guides and ADS Reconstruction Guides. ADS Orthognathic Guides are classified into Titanium and Resin Surgical Guides. ADS Orthognathic Titanium Guides are manufactured from Commercially Pure (CP) Titanium grade 4; they include mandibular and maxillofacial surgical guides with or without dental support (e.g. Le Fort, Genioplasty, Bilateral Sagittal Split Osteotomy (BSSO) Surgical Guides, etc.). Palatal Splints are also part of ADS Orthognathic Titanium Guides, which are optional guides used in orthognathic surgery to guide and support the correct teeth positioning and validate the patient’s final occlusion. ADS Orthognathic Resin Guides are manufactured through rapid prototyping using the Form 3B and Form 4B printers and Biomed Clear Resin from Formlabs. The resin guides also include splints (intermediate, final, and palatal), which are optional guides used in orthognathic surgery to guide and support the correct teeth positioning and validate the patient’s final occlusion. The ADS Reconstruction Guides are intended for mandibular and maxillofacial surgical procedures in adults, using patient grafts/flaps for reconstruction. These guides are made from Commercially Pure (CP) grade 4 titanium, produced through machining and are finished with an anodizing process. They are intended for use in various anatomical sites, including the maxilla, mandible and fibula. The reconstruction guides ensure precise transfer of the pre-surgical plan to the operating room, facilitating the correct placement and fixation of the patient’s bone grafts/flaps at the surgical site.

INTENDED USE/ INDICATIONS FOR USE
ADS Digital Planning Software 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 Digital Planning Software 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 surgical guides and splints for use in maxillofacial surgery. The ADS Digital Planning Software System is also intended as a preoperative software tool for simulating / evaluating surgical treatment options. The Digital Planning Software system is compatible with the ADS Patient-Specific Maxillofacial System and the ADS Diagnostic Models and should be used in conjunction with expert clinical judgment.