Abstract #2220

Statistical Equivalence Test Protocol for RF Performance of AIMD Systems

Li-Yin Lee¹, Shiloh Sison², Shi Feng³, Kishore Kondabatni⁴, and Richard Williamson⁵

¹BioStatistics, St. Jude Medical, Sylmar, CA, United States, ²Electrical Engineering, St. Jude Medical, Sunnyvale, CA, United States, ³Electrical Engineering, St. Jude Medical, Sylmar, CA, United States, ⁴St. Jude Medical, Sylmar, CA, United States, ⁵Program Management, St. Jude Medical, Sylmar, CA, United States

Test methods for MRI safety and RF safety of AIMD systems has been defined through ISO/TS 10974 are cumbersome to perform on every device and lead combination. A clear method for determination that two likely equivalent systems has not been described. The Concordance Correlation Coefficient has been described for this purpose in assay comparison. This paper evaluates the CCC method for RF equivalence in presence of measurement uncertainty, and confirms that the CCC method is simple and robust for this purpose.

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