0750 Performance Testing of a Novel Oral Appliance Material; A New Standard for OAT

Abstract

Abstract Introduction Traditionally, oral appliances for treating obstructive sleep apnea have borrowed from the disciplines of removable prosthetics and orthodontics. The materials, design and manufacturing have evolved little. Today, precision milled devices using innovative materials and designs have leapt past artisanal legacy devices. The use of artificial intelligent design to accurately replicate tooth surface anatomy and robotic manufacturing to insure precision are requiring higher table stakes to ‘get in the game’. Mill-able polymethylmethacrylate, MG6™ Technology materials and printed nylons have replaced cold cured acrylics, Thermacryl, soft liners and suck down platforms. The testing and material standards should also evolve as well. Methods Typically, no specific ISO testing is performed on legacy device compositions. This new medical grade class VI (the highest category) material promised to be more robust, safer and to have the highest biocompatibility. ISO testing was performed in the following arenas: ISO tests 10993-4 Hemolysis, 10993-4 in vitro hemocompatibility, 10993-5 cytotoxicity, 10993-6 short-term intramuscular implantation, 10993-10 intracutaneous injection, 10993-11 system toxicity and USP 38 physiochemical testing.Similarly, no specific durability testing is done beyond the safety requirement designs set by the FDA. This material was exposed to all the tradition stress, bend and compression testing as well as the MIL-STD-810H Military Free Fall Drop Test. Finally, stain, biogunk and the ease of keeping a device clean are always a concern with legacy device materials. Milled PMMA has been shown previously to be nearly impervious to stain and bioburden uptake. This material was tested along with predicates and PAP mask materials for comparison. Results ISO TestingThe Material passed all the tests as indicated in reports nos. BIO-ATX 1856,1857,1858, and BIO-GNT 8321. 832, 833. Military Drop TestThis material passed the military drop test (40 cases, each dropped 6 times). Method Test 810H section 4.6.5 Procedure IV Table 516.8-X Unpackaged handling. Stain TestingMilled Iterative PMMA DE = 3.06Milled Iterative EVO material DE = 3.20CPAP Mask plastic DE = 7.54Milled PMMA w/ soft Liner/Fulcrum Strap DE = 8.27CPAP Mask silicone DE = 11.60PMMA + Liner Anterior Hook DE = 19.05PMMA with Liner Herbst DE = 32.05Nylon with Airway DE = 90.70Nylon with Straps DE = 96.99 Conclusion Medical grade class VI material sets new standard for oral appliance material performance Support (If Any) Data provided by ProSomnus, ISO.org and the DOD.