Data Collection for the Validation of an AI Software to Support MSK Ultrasound Examination
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 79
- 试验地点
- 3
- 主要终点
- Rate of spatial (area) overlap of anatomical structure areas on the ultrasound image
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Pregnancy
- •Inability to lie flat
- •Open skin lesions or active infection at the scan site
- •Anatomical deformity in the joints to be scanned
研究组 & 干预措施
U.S population
干预措施: Ultrasound Scans (Device)
结局指标
主要结局
Rate of spatial (area) overlap of anatomical structure areas on the ultrasound image
时间窗: Up to 30 days from enrollment
The performance based on the rate of the spatial (area) overlapping of supported structures
Rae of correctly classifying the views of the joint
时间窗: Up to 30 days from enrollment
The performance based on the rate of correctly detecting views of the selected joint
次要结局
- Rate of correctly assigning anatomical structure completeness level for any scan view of the joint(Up to 30 days from enrollment)