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
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
Phased-Array Antenna Tools
The Sim4Life Phased-array Antenna Toolkit provides the most efficient solution on the market for the design, analysis, and optimization of 5G mmWave antenna arrays. It empowers engineers to rapidly develop and study phased-array antennas to meet demanding performance requirements, including regulatory compliance. The power density algorithm is fully compliant with IEC/IEEE 63195 standards on both flat and curved surfaces.
Key Features
Maximum exposure evaluator for worst-case peak power density for a given surface/phased-array antenna
Compliance evaluation based on surface-averaged power density
Total exposure ratio (TER) evaluator for devices with multiple EM emission sources (considers all sources simultaneously)
Easy-to-use beam steering tool
Novel solver-enhanced phantom model technique for realistic and accurate simulations at mmWave frequencies
Power density algorithm for flat and curved surfaces, fully compliant with IEC/IEEE 63195
Template-based tools for modeling phased-array antennas
Dedicated tools for creating CAD-based phased array models and setting up FDTD simulations
Efficient array-factor far-field evaluators for fast prototyping
MaxGain algorithm for computing the best possible performance along each spatial axis
Two-dimensional maps of spherical patterns such as gain/directivity for quantitative determination of regions with insufficient coverage
Direct comparison with measurement results from the DASY8/6 Module mmWave
Compatibility with circuit design software tools for analysis of feeding network effects and their optimization
Power density algorithm accepting measurement data from cDASY8/6 Module mmWave/ICEy mmWave as input
Sim4Life import of measurement-based auxiliary source reconstructions from DASY8/6 Module mmWave for detailed simulations
Applications
Design and optimization of next-generation mobile phones, 5G base stations, etc.
5G mmWave antenna array compliance assessment
Phased-array antenna design
Maximum exposure evaluation
Dosimetric Evaluation Tools
Sim4Life simplifies the dosimetric analysis and cross-validation of measurements obtained using SPEAG’s DASY Modules with a set of tools dedicated to fast evaluation and information rich visualization of key dosimetric quantities. These tools include the following evaluators:
Peak-spatial SAR (psSAR) evaluator – computes psSAR averaged over a specific mass with moving constant-mass cubes as specified in IEEE/IEC62704-1
Incident power density (iPD) evaluator – computes iPD averaged over a given surface in compliance with IEC/IEEE 63195.2
Absorbed power density (APD) evaluator – computes APD averaged over a given surface in compliance with the latest draft of IEC/IEEE TR APD
ICNIRP surface-averaged evaluator (1998) – computes the surface-averaged quantity recommended in the 1998 ICNIRP guidelines
ICNIRP volume-averaged evaluator (2010) – computes the volume-averaged quantity recommended in the 2010 ICNIRP guidelines
Worst-case parallel transmit (pTx) dosimetry, virtual observation points for online control
MRI implant safety (FDA certified)
Blood flow with and without cardiovascular implants (wall shear stress)
Focused ultrasound – acoustic radiation force, power deposition
Quality Assurance in Sim4Life Development
Sim4Life is developed according to an agile scrum procedure, and its components are subject to extensive quality assurance procedures. In short, a version control system meticulously records and tracks codebase changes made by developers, while an issue tracking system documents, prioritizes, and monitors bugs, issues, and feature requests (including internal and customer-driven requests). For each merge request, a continuous integration (CI) engine conducts the following categories of tests and logs all outcomes:
Automated unit tests: assessment of the smallest modules with well-defined inputs to ensure consistent outputs.
Automated integration tests: validation of the application's functionality when modules are combined, confirming correct data exchange and integration.
Automated application tests: application-specific workflows are re-run and compared against reference (target) outcomes for performance/results.
Furthermore, each Sim4Life release undergoes extensive testing and validation. Comprehensive verification and validation (V&V) documentation is available for each of the Sim4Life solvers. These documents chronicle comparisons with analytical and numerical benchmarks (including those drawn from relevant standards, such as IEEE/IEC 62704-1), and have been carefully designed to test relevant solver features and behaviors with adequate sensitivity. Agreement with reference benchmarks within the expected numerical uncertainty and correct convergence behavior are required. Whenever possible, verification steps are configured to run automatically with each software update.
In addition to automated testing, manual tests and execution of validation benchmark cases are conducted before each new Sim4Life version release to address areas not covered by automated testing (e.g. GUI behavior), and to allow for deviation from standardized routines. The issue tracking system generates feature and bug lists included in the release notes for each new version.
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