Evidence map›Paper›PMID 42082881›Full record

ArticleCardiovascular engineering and technology2026

Uncertainty Quantification of Finite Element Strain Predictions for a Nitinol Medical Device: Influence of Input Parameter Probability Distribution on Output Uncertainty.

Ian A Carr, Kenneth I Aycock, Harshad Paranjape, Craig Bonsignore, Jason D Weaver, Brent A Craven

Abstract read
In one paragraph

Article in Cardiovascular engineering and technology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Ian A CarrOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA. ian.carr@fda.hhs.gov.ORCID http://orcid.org/0000-0001-7292-506X
Kenneth I AycockOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Harshad ParanjapeConfluent Medical Technologies, Carlsbad, CA, USA.
Craig BonsignoreMedRes International, Phoenix, AZ, USA.
Jason D WeaverOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Brent A CravenOffice of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.

Funding

Intramural FDA HHS FD999999
6 · The paper itself

Abstract

Establishing credibility of computational modeling of medical devices is critical when an incorrect decision could cause patient harm. Uncertainty quantification (UQ) can impart credibility by providing an estimate of the model uncertainty due to variability in the input parameters. To perform UQ, non-deterministic simulations are performed where model inputs are represented by probability density functions (PDFs). Computational modeling of medical devices, however, is typically constrained by limited sample sizes and sparse experimental data. As a result, it is generally not possible to definitively characterize the true input distributions for UQ. The sparse data must instead be fit with an assumed PDF. While the assumption of a Gaussian distribution is common, other PDFs may be more appropriate depending on the context. In this study, we investigate the influence of input PDF choice on output uncertainty from non-deterministic finite element simulations of a nitinol medical device. We first characterize the geometry, material properties, and the experimental test conditions. We then perform a screening study to determine the relative importance of each parameter on our primary quantity of interest (QOI), peak strain amplitude. Next we perform three UQ studies, each using one of three different PDF types: Gaussian, gamma, and uniform. By sampling the input parameter PDFs using a Latin hypercube approach, we perform non-deterministic simulations to predict the output distributions. Our results show that use of uniform distributions yields output predictions with the largest variance and is thus the most conservative choice unless infrequent events are of interest. In contrast, we show that for conservative predictions of extreme events, a better choice is to use Gaussian or gamma distributions with asymptotic tails of finite probability that are neglected when using uniform distributions.

Indexed as

AlloysFinite Element AnalysisComputer SimulationStress, MechanicalUncertaintyAlloysnitinolFinite element analysisInferior vena cava filterLatin hypercube samplingNitinolProbability density functionUncertainty quantification

Identifiers

PMID42082881
PMCPMC13215217

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.