U.S. Food and Drug Administration

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.

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 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.

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 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).

This tool provides a benchmark validation data set for laminar flow in an anatomical vascular model of the inferior vena cava (IVC).

Chemicals List for Analytical Performance (CLAP)

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.

This regulatory science tool presents a method for assessing credibility of patient-specific computational models implemented in medical device software. 

This regulatory science tool presents a set of tissue-mimicking phantoms suitable for benchtop performance assessment of photoacoustic imaging (PAI) devices.