Accuracy, Repeatability, and Reproducibility of a Hand-Held Structured-Light 3D Scanner across Multi-Site Settings in...

Area of Science:

• Biomedical Engineering
• Medical Device Technology

Background:

• Accurate 3D scanning is crucial for prosthetic device fitting and fabrication.
• Evaluating the performance of handheld 3D scanners in multi-site settings is essential for clinical adoption.

Purpose of the Study:

• To assess the accuracy, repeatability, and reproducibility of the EINScan Pro 2X Plus structured-light 3D scanner.
• To determine the suitability of this 3D scanner for multi-site applications in lower limb prosthetics.

Main Methods:

• Four lower limb models were scanned using a metrological 3D scanner and the EINScan Pro 2X Plus by multiple operators across three sites.
• Accuracy was evaluated against a reference scanner, repeatability by repeated scans by one operator, and reproducibility across different operators and sites.

Main Results:

• Mean radial error was below 0.25 mm, mean angular error below 4°, and root mean square error of radial distance below 1 mm.
• Limits of agreement for perimeters and volumes were less than 3.5%.
• The scanner exhibited good performance metrics across all tested parameters.

Conclusions:

• The EINScan Pro 2X Plus 3D scanner with High Definition Prime Pack shows high accuracy, repeatability, and reproducibility.
• Its performance supports its use in multi-site settings for lower limb prosthetics evaluation and manufacturing.