NSITE Scoliosis Device Reproducibility Protocol

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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NSITE Scoliosis Device Reproducibility Protocol

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Diagnostic Test: NSite 3D Scanning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages 10 and 18 years old Referred for evaluation of or diagnosed of adolescent idiopathic scoliosis Exclusion Criteria: Scoliosis caused by another condition (e.g., secondary scoliosis) Parents/guardians unable to consent English is not the primary language (to avoid miscommunication)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adolescent Idiopathic Scoliosis<br>Inclusion criteria Ages 10 and 18 years old Referred for evaluation of or diagnosed with adolescent idiopathic scoliosis Exclusion criteria Scoliosis caused by another condition (e.g., secondary scoliosis) Parents/guardians unable to consent English is not the primary language (to avoid miscommunication) | Diagnostic Test: NSite 3D Scanning<br>* Three separate users will enter the exam room and use the NSite application to scan the patient in the bending position. These users may include research coordinators, physicians, or other authorized staff. The NSite application will have a user tutorial on how to scan patients that users are instructed to watch prior to conducting a scan. All participants are asked to remove clothing above the waist but may keep a bra or tight-fitting shirt on during the scanning procedures. The patient will be asked to assume a forward bending position. One user will capture a scan of the patient's back in this position. The user will calibrate the device and then walk around the patient while scanning per app directions. Once this user captures the scan, it will be processed by the application. New scans will then be obtained by the two other users. Once all users have captured a scan, the scanning process and patient participation will be completed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the reproducibility of NSite device | Percentage of scan outputs reproducible. The percentage of scan sets (3 scans for each participant) that have reproducible predicted probabilities for major curve magnitude ≥ 20 degrees. A reproducible output will be defined as a scan set in which all scans have overlapping 95% confidence intervals for the predicted probability of major curve magnitude ≥ 20 degrees. | Anticipated to take about one month in order to recruit, enroll, and scan 13 patients. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Feedback | User feedback will be collected throughout testing in the form of open-ended comments. These will be collated and reported. | Anticipated to take about one month in order to recruit, enroll, and scan 13 patients. |