Data Collection for the Validation of an Artificial Intelligence Software to Support Musculoskeletal Ultrasound Examination

Data Collection for the Validation of an AI Software to Support MSK Ultrasound Examination

This study conducted at three locations, aiming to collect ultrasound images from volunteers and assess the performance of an AI software, MSK Go, using these images.

The software to be assessed is designed to assist physicians and healthcare professionals in performing ultrasound exams by classifying scan views and identifying key anatomical structures during a musculoskeletal ultrasound examination.

The main question the study aims to answer is whether the AI software performs safely and effectively for future clinical use.

Study Overview

• Status: Completed
• Conditions: Ultrasound Imaging of Anatomical Structures
• Intervention / Treatment: Device: Ultrasound Scans

Detailed Description

This study is designed to validate the performance of the MSK Go software in classifying musculoskeletal ultrasound examination views and segmenting relevant anatomical structures in a U.S. population.

Data collection method and analysis:

A total of 79 subjects were enrolled and undergone shoulder, elbow, wrist/hand, knee, and foot/ankle scans at three clinical sites. Ultrasound examinations were performed by MSK ultrasound experts without using MSK Go.

Each participant spent approximately 30 minutes in the ultrasound scanning session. Demographic data were collected for all subjects. An FDA-cleared, commercially available ultrasound device was used at each location.

The collected ultrasound scans are then annotated by healthcare professionals with expertise in musculoskeletal sonography.

In a post hoc analysis, the ultrasound clips were processed using the AI software, and the software-generated classifications of views and segmentations of anatomical structures were compared with the reference annotations .

Convenience sampling was applied during data collection to ensure that participants represented a balanced distribution across age, gender, BMI, and ethnicity.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Scripps Clinic Torrey Pines
  • New York
    • Brooklyn, New York, United States, 11204
      • AABP Integrative Pain Care and Wellness Clinic
  • Texas
    • Woodland, Texas, United States, 77380
      • Memorial Hermann Houston Health & Sports Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Provision of a signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

• Pregnancy
• Inability to lie flat
• Open skin lesions or active infection at the scan site
• Anatomical deformity in the joints to be scanned

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: U.S population	Device: Ultrasound Scans; Scanning for musculoskeletal examination views on shoulder, elbow, wrist/hand, knee, and foot/ankle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of spatial (area) overlap of anatomical structure areas on the ultrasound image	The performance based on the rate of the spatial (area) overlapping of supported structures	Up to 30 days from enrollment
Rae of correctly classifying the views of the joint	The performance based on the rate of correctly detecting views of the selected joint	Up to 30 days from enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of correctly assigning anatomical structure completeness level for any scan view of the joint	The performance based on the completeness rate of detection level of the set of supported anatomical structures by the software	Up to 30 days from enrollment

Collaborators and Investigators

• Sponsor: Smart Alfa Teknoloji San. ve Tic. A.S.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): November 30, 2025

Study Registration Dates

• First Submitted: January 11, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): January 13, 2026
• Last Update Submitted That Met QC Criteria: January 12, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: ultrasound; Artificial Intelligence; Musculoskeletal
• Other Study ID Numbers: MSK-001-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No