Regulatory Science Tools Catalog
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.
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.
This regulatory science tool is a model for establishing analyte recovery in chemical characterization studies following liquid-liquid extraction.
This regulatory science tool is a lab method that computes bone microstructure metrics to characterize bone morphology and skeletal geometry.
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).
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.
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.
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.
This regulatory science tool presents an open-access dataset tool for the assessment of wearable technology deriving gait parameters.
This regulatory science tool presents a set of tissue-mimicking phantoms suitable for benchtop performance assessment of photoacoustic imaging (PAI) devices.
This regulatory science tool presents a method for assessing credibility of patient-specific computational models implemented in medical device software.
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.
Chemicals List for Analytical Performance (CLAP)
This tool provides a benchmark validation data set for laminar flow in an anatomical vascular model of the inferior vena cava (IVC).
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).
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.
This RST is a database tool consisting of nine mock circulation loop (MCL)-generated datasets for characterizing three dynamic attributes of pressure-based cardiac output monitoring systems that apply an algorithm to intra-radial arterial blood pressure waveforms for cardiac output and stroke volume variation measurements.
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].
This RST outlines a strategy for estimating the presence of cyclic phase transformation to aid in the determination of appropriate load levels for Fatigue to Fracture testing of nitinol components. Specifically, it includes a flowchart (Figure 1 in Appendix) to estimate the low to high cycle fatigue transition using either computational or experimental methods. Based on the output of the analysis, the user can create a test plan for fatigue testing per ASTM F3211 which includes both expected low cycle fatigue fractures and runouts.
The DAMSEL tool is a digital collection of published information related to the safety profile of materials commonly used in the manufacture of medical devices. This interactive application allows users to filter and access key response data for studies relating to material biocompatibility along with hyperlinks to the relevant original studies.