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Regulatory Science Tools Catalog

This regulatory science tool comprises a model for conducting a retrospective analysis of COVID-19 intervention strategies.
Therapeutic Ultrasound
This regulatory science tool is a lab method that may be helpful while evaluating high intensity therapeutic ultrasound (HITU) devices.
MXR
This regulatory science tool (RST) describes a method to characterize digital image quality on optical see-through augmented reality head-mounted displays (AR HMDs) in ambient lighting conditions. The method can be implemented to measure AR display performance, such as Michelson contrast and contrast uniformity.
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).
Cardiovascualar
This regulatory science tool is a lab method tool used for simulating target clinical use patient conditions on the bench using a mock circulatory loop in conjunction with the ISO 14708-5 standard specifications for circulatory support devices.
Cardiovascualar
This regulatory science tool is a lab method in the form of a physical mock circulation loop (MCL) used for simulating peripheral radial pressure waveforms.
Materials Program Image
This regulatory science tool is a model for establishing analyte recovery in chemical characterization studies following liquid-liquid extraction.
MID
This regulatory science tool is a lab method that computes bone microstructure metrics to characterize bone morphology and skeletal geometry.
MXR
This regulatory science tool is a method for measuring the line spread function (LSF) and calculating the modulation transfer function (MTF) for head mounted displays (HMDs).
MXR
This regulatory science tool presents a method to measure the radially variant contrast on virtual reality head-mounted displays (VR HMDs) using circular concentric ring patterns, which can be implemented to characterize image quality, including Michelson contrast and effective resolution, on VR HMDs equipped with optical lenses.
AI ML
This regulatory science tool presents a method (web-based decision tree) that may help developers select appropriate metric and endpoint for Artificial Intelligence (AI) / Machine learning (ML) classification algorithms in medical imaging.
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.
HDI
This regulatory science tool presents an open-access dataset tool for the assessment of wearable technology deriving gait parameters.
MID
This regulatory science tool presents a set of tissue-mimicking phantoms suitable for benchtop performance assessment of photoacoustic imaging (PAI) devices.
CM&S Program Image
This regulatory science tool presents a method for assessing credibility of patient-specific computational models implemented in medical device software. 
Biocompatibility and Toxicology
This regulatory science tool is a method that applies the ISO 10993-17 toxicological risk assessment approach to medical device extractables screening data to assess systemic toxicity, genotoxicity, carcinogenicity, or reproductive/developmental toxicity in the biocompatibility evaluation of a medical device.
Cardiovascualar
This tool provides a benchmark validation data set for laminar flow in an anatomical vascular model of the inferior vena cava (IVC).
Neurology
This RST contains a set of machine or deep learning algorithms which can be utilized in the development of relevant medical devices to assist in the prediction of traumatic brain injury (TBI) and stroke according to resting electroencephalography (EEG).
Cardiovascualar
The 3D human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) Cardiac Contractility Modulation (CCM) Tool, 3D hiPSC-CM CCM Tool, is a laboratory method that includes detailed characterization and protocols for evaluating contractile response in healthy 3D hiPSC-CM models. The core elements of this tool include the ability to perform in vitro CCM contractility assays, including contraction force and kinetics, in 3D hiPSC models for various known and unknown electrophysiology pulse waveform parameters and combinations.