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Regulatory Science Tools Catalog

Digi Path
This regulatory science tool is a software program written in Python for analyzing whole slide images (WSIs) and assisting developers or pathologists in the assessment of machine learning algorithms used in digital pathology.
This regulatory science tool comprises a model for conducting a retrospective analysis of COVID-19 intervention strategies.
HDI
This regulatory science tool comprises a computer model of a human action potential, which includes the effects of heart failure (HF) and the anti-arrhythmic drugs amiodarone (AM) and d-sotalol (DS).
CM&S Program Image
This regulatory science tool presents Python-based software for evaluating computer models that predict the number of COVID-19 deaths or hospitalizations expected in a specific locality.
CM&S Program Image
This regulatory science tool presents a method for assessing credibility of patient-specific computational models implemented in medical device software. 
Cardiovascualar
This RST, a “threshold-based” validation method, provides a means to determine an acceptance criterion for computational models. A “credible” computational model has the potential to provide a meaningful evaluation of safety in medical-device submissions [1,2].
MID
The Virtual Imaging Clinical Trials for Regulatory Evaluation (VICTRE) computer modeling pipeline is a set of tools that allow for the replication of clinical trials of in silico breast radiographic images for the evaluation of digital mammography (DM) and digital breast tomosynthesis (DBT) devices.
CM&S Program Image
A series of benchmark problems with known exact solutions that can be used to verify if tissue-level (e.g., ventricular, atrial) computational models of cardiac electrophysiology have been implemented correctly
MID
The Virtual Family provides detailed three-dimensional computational models of the human anatomy including an adult male, an adult female, and two children
InterOp
A computational modeling tool that provides first-pass estimation of the thermal effect produced in the vaginal wall by vaginal therapy devices.
CM&S Program Image
This study demonstrates the application of gold-standard method of manufactured solutions (MMS) code verification to verify a commercial finite element code for elastostatic solid mechanics analyses relevant to medical devices. The Python/SymPy code used to generate source terms is available as supplemental material.
Cardiovascualar
Parsimonious (reduced complexity) model and software of the rabbit action potential amenable to large scale simulations of arrhythmias
MID
MC-GPU is a Monte Carlo simulation code that can generate synthetic radiographic images and computed tomography (CT) scans of realistic models of the human anatomy using fast Graphics Processing Unit (GPU) cards.
Cardiovascualar
An approach for optimal experimental design and estimability analysis for mechanistic models of cardiac electrophysiology to determine their ‘identifiability’
CM&S Program Image
A finite element model of the human shoulder for simulating humeral abduction and calculating outputs such as contact force, contact pressure, contact area, stress, and strain.
AI ML
Statistical tools (java GUI and R package) to analyze, size, and simulate multi-reader multi-case (MRMC) reader studies
Cardiovascualar
An implementation of a canine action potential model appropriate for comprehensive parameter sensitivity analysis and uncertainty quantification
CM&S Program Image
A "threshold-based" validation approach that provides a well-defined acceptance criterion, which is a function of how close the simulation and experimental results are to the safety threshold, for establishing the model validity.
MID
A software program written in Matlab for analyzing color performance testing data in endoscopy devices