Fully automated Tier 3 analysis of radio frequency (RF)-induced local power deposition at the electrodes of implantable devices for millions of excitations. IMAnalytics and MRIxViP are qualified by the FDA for MRI safety evaluations.
IMAnalytics is a novel software platform solution for the comprehensive safety evaluation of implantable devices. The module is designed to characterize the RF-induced heating at the distal electrodes of implantable devices, using a variant of the Tier 3 approach as defined in ISO/TS 10974. It is tailored for elongated lead structures by making use of the transfer function method described in Annex K of the same technical specification.
IMAnalytics evaluation tool and the IT'IS field libraries MRIxViP1.5T/3.0T are the first FDA-approved computational modeling Medical Device Development Tool (MDDT). Report
Version 2.0 of IMAnalytics has been extensively tested and validated.
The verification benchmarks use as reference either analytic results from simple setups or results produced by different implementations of similar algorithms. When possible, all the verification steps are automated in such a way that they can be run for every update of the software.
Our approach combines some simplified test fixtures with realistic scenarios. In the first case, the reference results are derived analytically while in the second case they are obtained using an alternative algorithm or implementation.
Full verification and validation (v&v) documentation, including the descriptions of our test fixtures and validation criteria, is provided to all customers.
The verification report defines six tests, their results and acceptance criteria to verify the software Module IMAnalytics. They are considered to be sufficient to determine the correctness and completeness of thesoftware module for applications in their context of use, i.e., evaluations according to Tier 3 of ISO/TS 10974.
The verifications have been performed for the Implant Safety Analysis Module IMAnalytics V2.0.
||Description||Version||Test Date||Test Results|
|1||Q-matrix||V2.0||March 19, 2019||passed|
|2||Etan evaluation||V2.0||March 19, 2019||passed|
|3||Mass evaluation||V2.0||March 19, 2019||passed|
|4||End-to-end workflow||V2.0||March 19, 2019||passed|
|5||SAR limits||V2.0||March 19, 2019||passed|
|6||B1 limits||V2.0||March 19, 2019||passed|
|7||Deposited Power and Induced Voltage||V2.0||March 19, 2019||passed|
|8||Manual comparison||V2.0||March 19, 2019||passed|
The Implant Safety Analysis Module IMAnalytics V2.0 passed all tests and is considered error free in its contexts of use.
Histogram of Tier 3 deposited power for a given position of the anatomical models.
Selection of anatomical model and routings.
Tier 3 deposited power for different imaging positions.