IMAnalytics
IMAnalytics is a novel software platform solution for the comprehensive safety evaluation of implantable devices. The module uses the Tier 3 approach as defined in ISO 10974 to characterize RF-induced power deposition and heating at the distal electrodes of implantable devices, and the voltage at the lead terminals of the pulse generator. Furthermore, it extracts the RF-induced electric field in a region of interest for use in ISO 10974’s Tier 2 approach, or for calibrating ASTM F2182 phantom measurements. IMAnalytics and the IT'IS MRIxViP1.5T/3.0T field libraries are the first computational modeling-based Medical Device Development Tools (MDDT) approved by the FDA.
Key Features
- Full compatibility with the MRIxViP exposure libraries (IT’IS Foundation, Switzerland)
- Full compatibility with the MRIxLAB library (IT’IS Foundation, Switzerland) of pre-computed, induced fields in the Test Field Diversity phantoms of MITS 1.5/3.0T and MITS-TT
- Streamlined GUI for fast access to all built-in tools, along with easy-to-launch Jupyter notebooks for advanced analysis
- Zip file-based export of all results (incl. plots, raw data, and study parameters) for full traceability and archiving
- Preprocessing of EM field data (up to terabytes) from numerous combinations of birdcage types, anatomies, landmark positions, postures, and implant routing paths
- Import of implant transfer functions measured with the piX system
- Assessment of different polarization schemes and exposure conditions through automated evaluation of I and Q channel excitation settings
- Efficient evaluation of up to millions of exposure scenarios with extraction of deposited power statistics
- Evaluation of deposited power/induced voltage across operating modes (normal, first level controlled)
- Computation of Tier 3 induced voltage
- Exposure limit enforcement in terms of whole-body specific absorption rate (SAR), partial-body SAR, head SAR or B1 field values
- Enhanced B1 field analysis with flexible slicing and visualization capabilities, including maximum intensity projections (MIPs) and customizable B1+ and B1– field views across arbitrary planes
- Homogeneity metrics like the coefficient of variation based on masked regions and assess average B1+ or B1– within defined slabs around the isocenter
Applications
- MR safety with respect to RF-induced heating of: cardiac pacing/sensing leads, implantable cardioverter defibrillators (ICD), spinal cord stimulators (SCS), and deep-brain stimulation (DBS) systems
- Prediction of ISO 10974 Tier 3 in vitro deposited power/induced voltage for different test routings, incident field polarizations, and tissue-simulating media; fast and accurate experimental transfer function validation
Verification
Each released version 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.