Data Collection for the Validation of an AI Software to Support Ultrasound-Guided Regional Anesthesia Procedures

This study aims to validate the performance of AI technology in regional anesthesia through a clinical evaluation conducted on the U.S. population.

Data collection method and Analysis:

A total of 40 healthy subjects were enrolled and scanned by three different expert anesthesiologists. Twelve different peripheral nerve and plane block regions supported by the Nerveblox software were scanned bilaterally. Each participant spent approximately 30 minutes in the ultrasound scanning session, with each ultrasound clip lasting 10 seconds.

Age, gender, weight, and height data were collected and reported for each subject. Subjects were selected to balance the BMI distribution between those with BMI < 30 kg/m² and those with BMI ≥ 30 kg/m². An FDA-cleared, commercially available ultrasound device was used during the scanning process, and the Nerveblox software was not utilized in the data collection sessions.

Collected ultrasound clips included both ideal and non-ideal block views. The collected ultrasound scans were processed post hoc by the Nerveblox software, and the resulting outputs, alongside the raw ultrasound images, will be assessed by a panel of expert anesthesiologists. These clips were reviewed by two separate groups of reviewers, each consisting of three members.