Abstract
INTRODUCTION
Statistical shape models (SSM) have become a common tool to create reference models for design input and verification of total joint implants. In a recent discussion paper around Artificial Intelligence and Machine Learning, the FDA emphasizes the importance of independent test data [1]. A leave-one-out test is a standard way to evaluate the generalization ability of an SSM [2]; however, this test does not fulfill the independence requirement of the FDA. In this study, we constructed an SSM of the knee (femur and tibia). Next to the standard leave-one-out validation, we used an independent test set of patients from a different geographical region than the patients used to build the SSM. We assessed the ability of the SSM to predict the shapes of knees in this independent test set.
METHODS
A dataset of 82 computed tomography (CT) scans of Caucasian patients (42 male, 40 female) from 11 different geographic locations in France, Germany, Austria, Italy and Australia were used as training set to make an SSM of the femur and tibia. A leave-one-out test was performed to assess the ability of the SSM to predict shapes within the training set. A test dataset of 4 CT scans of Caucasian patients from Russia were used for the validation. The SSM was fitted onto each of the femur and tibia shapes and the root mean square error (RMSE) was measured.
RESULTS
The leave-one-out tests showed that the femur and tibia SSMs were able to predict patients in the input population with an RMSE of 0.59 ± 0.1 mm (average ± standard deviation) for the femur and 0.70 ± 0.1 mm for the tibia. The validation test showed that the femur and tibia SSMs were able to predict the shapes of the Russian patients with an RMSE 0.62 ± 0.1 mm for the femur and 0.71 ± 0.1 mm for the tibia.
DISCUSSION
There were no significant differences in the ability of the SSM to predict femur and tibia shapes of patients in a new geographic region compared to the ability of the SSM to predict shapes within the training set.
CONCLUSIONS
Based on this study, 11 different geographic locations in France, Germany, Austria, Italy and Australia provide a complete sample of the Caucasian population. Using an independent set of CT scans is a valuable tool to further validate the generalization ability of an SSM
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