The primary objective of this study is to validate the reproducibility of the NSite device, which uses a mobile device camera to create 3D scan and a predict a probability of having clinically significant scoliosis. This will be assessed by having 3 separate users use the device to scan participants. Each participant will be measured by each user with each user receiving a predicted probability of major curve magnitude (i.e., Cobb angle) greater than or equal to 20 degrees for that participant including a confidence interval. The predicted probabilities generated by the device for each patient by the 3 users will be compared to determine if they are similar or different by evaluating if their confidence intervals are overlapping or not.~The NSite Scoliosis Assessment App is intended as a clinical decision support tool and requires interpretation by the healthcare professional. It is intended for use for children and adolescent patients 10 to 18 years old. It is intended for use by prescription only. It provides a calculated Asymmetry Index for patients with or at risk for scoliosis, which will yield an output of percentage risk of major curve magnitude (i.e., Cobb angle) greater than or equal to 20 degrees, with 95% confidence intervals.
This is a single center, prospective, non-randomized reproducibility study of the NSite device in patients undergoing evaluation for scoliosis. The NSite device is a pre-market, investigational device. The study will enroll 13 eligible patients, who will be scanned using the NSite device by 3 separate users in order to assess if the device generates similar results across users. This data will be used to support 510(k) submission.