Validation of the Finite Element Model versus Biomechanical Assessments of Dental Implants and Total Knee Replacements

Author:

Kang Kwan-Su12ORCID,Park Kwang-Min1,Ahn Jin-Woo1,Jo Min-Young3,Oh Yu-Rim3,Youn Jin-Ho3ORCID,Lee Jeong-Woo3,Je Dong-Young3,Jung Tae-Gon1ORCID

Affiliation:

1. Medical Device Development Center, Osong Medical Innovation Foundation, Cheongju-si 28160, Republic of Korea

2. Department of Biomedical Engineering, School of Medicine, Chungbuk National University, Cheongju-si 28644, Republic of Korea

3. Department of Biomedical Engineering, College of Biomedical Science & Engineering, Inje University, Gimhae-si 50834, Republic of Korea

Abstract

Computer modeling and simulation (CM&S) technology is widely used in the medical device industry due to its advantages such as reducing testing time and costs. However, the developer’s parameter settings during the modeling and simulation process can have a significant impact on the results. This study developed a test model for the rotational shear strength of dental implants and the constraint force of total knee replacements based on CM&S technology and proposes ideal parameters to ensure reliability. For dental implants, the load area and sliding contact conditions were considered, and for total knee replacements, the friction coefficient, medial–lateral displacement, valgus–varus rotation, and elastic modulus were considered. By comparing the simulation results and mechanical tests, boundary conditions with an error rate of less than 1.5% were selected. When a jig (gripper and collector) was applied with the same boundary conditions, an error rate of 48~22% occurred; otherwise, it was confirmed that the error rate was within 10~0.2%. The FE model was verified with an error of 2.49 to 3% compared to the mechanical test. The friction coefficient variable had the greatest influence on the results, accounting for 10 to 13%, and it was confirmed that valgus–varus rotation had a greater influence on the results than medial–lateral displacement. Relatively, the elastic modulus of the insert had the least effect on the results. These research results are expected to make CM&S techniques useful as a medical device digital development tool (M3DT) in the development of total knee replacements and dental implants.

Funder

Ministry of Food and Drug Safety

Publisher

MDPI AG

Subject

Bioengineering

Reference34 articles.

1. Finite Element Analysis in Spine Research;Fagan;Proc. Inst. Mech. Eng. Part H,2002

2. Assessing the Use of Finite Element Analysis for Mechanical Performance Evaluation of Intervertebral Body Fusion Devices;Baumann;JOR Spine,2021

3. Ministry of Food and Drug Safety (2015). Performance and Safety Evaluation Test Manual for Dental Implants.

4. US Food and Drug Administration (2022). Successes and Opportunities in Modeling & Simulation for FDA.

5. (2018). Assessing Credibility of Computational Modeling through Verification and Validation: Application to Medical Devices (Standard No. ASME V&V 40).

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