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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| U.S population | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Scans | Device | Scanning for musculoskeletal examination views on shoulder, elbow, wrist/hand, knee, and foot/ankle. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic Torrey Pines | La Jolla | California | 92037 | United States | ||
| AABP Integrative Pain Care and Wellness Clinic |
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| Brooklyn |
| New York |
| 11204 |
| United States |
| Memorial Hermann Houston Health & Sports Medicine | Woodland | Texas | 77380 | United States |