Impact of Implant Manufacturing Variability & Number of Measurements on Assessing RF-Induced Lead Heating & Injection Voltage

Motivation: Establishing a validated predictive ISO/TS 10974:2018 Tier 3 model for RF-induced lead heating and injection voltage of an implantable medical device can be extensive and time-consuming. Goal(s): Investigate the impact of lead manufacturing variability and number of in-vitro measurements on the resulting model's Transfer Function scalar, A. Approach: Lead heating or injection voltage was assessed for SCS and DBS systems for a varying number of samples and measurements and the resulting A values were compared. Results: The impact on A was minimal and as few as six measurements of one lead sample can develop a reliable model. Impact: Optimization of the needed number of in-vitro radiated measurements and active implantable medical device (AIMD) lead samples for ISO/TS 10974:2018 Tier 3 based Clause 8 (RF-induced lead heating) and Clause 15 (RF-induced injection voltage) MR Conditional safety assessments.