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Regulatory Science Tools Catalog

MID
This regulatory science tool is a method and phantom design for the evaluation of iodine-specific quantitative measurements, specifically the accurate estimation of iodine concentration within contrast-enhanced spectral CT.
MID
This regulatory science tool is a lab method that computes bone microstructure metrics to characterize bone morphology and skeletal geometry.
MID
This regulatory science tool presents a set of tissue-mimicking phantoms suitable for benchtop performance assessment of photoacoustic imaging (PAI) devices.
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.
MID
The Virtual Family provides detailed three-dimensional computational models of the human anatomy including an adult male, an adult female, and two children
MID
Test methods that provide a practical approach for objective, quantitative evaluation/comparison of fundamental performance in near-infrared fluorescence imagers.
MID
Method to fabricate realistic microcalcification simulants with adjustable density and sizes, for insertion into phantoms used to evaluate x-ray breast imaging systems
MID
A method to assess texture reproduction of camera-phone-based medical devices with a dead leaves target
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.
MID
Tool for assessing image quality of advanced nonlinear CT image reconstruction and denoising products, including but not limited to statistical iterative, model-based iterative, and deep learning-based methods
MID
Best practices for standardized performance testing of infrared thermographs intended for fever screening
AI ML
Statistical tools (java GUI and R package) to analyze, size, and simulate multi-reader multi-case (MRMC) reader studies
MID
A mathematically easy to understand and experimentally simple method to quantitatively and objectively evaluate endoscope geometric distortion
MID
Digital model available on NIH's 3D Print Exchange site that can be used to fabricate tissue simulating phantoms with biomimetic vascular structures derived from a clinical image
MID
A software program written in Matlab for analyzing color performance testing data in endoscopy devices