Abstract
Objective
We aimed to perform an external validation of an existing commercial AI software program (BoneView™) for the detection of acute appendicular fractures in pediatric patients.
Materials and methods
In our retrospective study, anonymized radiographic exams of extremities, with or without fractures, from pediatric patients (aged 2–21) were included. Three hundred exams (150 with fractures and 150 without fractures) were included, comprising 60 exams per body part (hand/wrist, elbow/upper arm, shoulder/clavicle, foot/ankle, leg/knee). The Ground Truth was defined by experienced radiologists. A deep learning algorithm interpreted the radiographs for fracture detection, and its diagnostic performance was compared against the Ground Truth, and receiver operating characteristic analysis was done. Statistical analyses included sensitivity per patient (the proportion of patients for whom all fractures were identified) and sensitivity per fracture (the proportion of fractures identified by the AI among all fractures), specificity per patient, and false-positive rate per patient.
Results
There were 167 boys and 133 girls with a mean age of 10.8 years. For all fractures, sensitivity per patient (average [95% confidence interval]) was 91.3% [85.6, 95.3], specificity per patient was 90.0% [84.0,94.3], sensitivity per fracture was 92.5% [87.0, 96.2], and false-positive rate per patient in patients who had no fracture was 0.11. The patient-wise area under the curve was 0.93 for all fractures. AI diagnostic performance was consistently high across all anatomical locations and different types of fractures except for avulsion fractures (sensitivity per fracture 72.7% [39.0, 94.0]).
Conclusion
The BoneView™ deep learning algorithm provides high overall diagnostic performance for appendicular fracture detection in pediatric patients.
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Data availability
The trained AI presented in this paper and clinical dataset with its corresponding ground truth, AI readings’ results are available upon request from the corresponding author. The development dataset and the AI models, parts of commercial software, are not available to public.
Code availability
The code underlying this work can be found online at https://github.com/facebookresearch/detectron2.
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Funding
Our research was sponsored by Gleamer, the developer of AI and software (BoneView™). The sponsor was involved with the study design. Manuscript writing was performed by independent authors who were not employees of Gleamer (Daichi Hayashi, Ali Guermazi).
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Our study was approved by the WellCare Group (WCG) institutional review board (approval number 20202256). The need for informed consent was waived because our study was retrospective and all images were totally anonymized and stripped of any clinical information. HIPAA requirements were strictly followed.
Conflict of interest
Ali Guermazi is a shareholder of BICL, LLC, and Consultant to Pfizer, Novartis, Regeneron, AstraZeneca, Merck Serono, and TissueGene.
JV, ZZ, AD, TN, AT, EL, AP, Albane Grandjean are employees of Gleamer.
AD is the Chief Technical Officer and co-founder of Gleamer.
NER is the Chief Medical Officer and co-founder of the Gleamer.
All other authors have no other conflict of interest to report.
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Hayashi, D., Kompel, A.J., Ventre, J. et al. Automated detection of acute appendicular skeletal fractures in pediatric patients using deep learning. Skeletal Radiol 51, 2129–2139 (2022). https://doi.org/10.1007/s00256-022-04070-0
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DOI: https://doi.org/10.1007/s00256-022-04070-0