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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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