HipStudio Analysis
Replasia BVHipStudio Analysis is a cloud-based image analysis service that processes hip CT scans to create detailed 3D models and simulate joint motion. It provides clinicians with reports to aid in diagnosing and planning treatments for various hip conditions, like developmental dysplasia and femoroacetabular impingement.
Intended Use
HipStudio Simulation Service is an online image analysis service indicated for skeletally mature individuals suspected of suffering from symptomatic or asymptomatic hip conditions including but not limited to developmental dysplasia of the hip (DDH) and femoroacetabular impingement (FAI). It enables clinicians to obtain 3D motion simulation reports based on CT image data.
Technology
HipStudio uses a cloud-based workflow consisting of secure image upload, segmentation and 3D model creation (using Mimics software), and proprietary analysis that simulates treatment scenarios and provides automated clinical reports. The service is operated by trained personnel, and outputs are delivered as structured reports to clinicians.
Performance
Non-clinical performance testing included software verification and validation, accuracy and reproducibility of segmentation and simulation modules, usability validation, clinical association mapping, and predicate output equivalence. All acceptance criteria were met, demonstrating the device performs as intended and is comparable to the predicate. No human clinical data were provided.
Predicate Devices
No predicate devices specified
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