Vent Creativity Knee v1.0 (Hermes)
Vent CreativityVent Creativity Knee v1.0 (Hermes) is a software tool that processes CT scan images of the knee to segment bones and generate surgical planning data. It uses AI models to accurately identify bone structures and landmarks, aiding clinicians in diagnosis and preoperative planning. The software also supports the creation of physical replicas based on imaging data, facilitating orthopedic applications.
Intended Use
Hermes is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as preoperative software for diagnostic and surgical planning. Output files can be used for fabrication of physical replicas for diagnostic purposes in orthopedic applications. The software is intended to be used with other diagnostic tools and expert clinical judgment.
Technology
The software takes DICOM CT scans as input and uses a convolutional neural network trained on arthritic knee CT scans to segment and landmark bones. It generates point clouds for accurate landmark identification and calculates surgical cut planes. The system operates on an encrypted cloud platform with automated processing workflows and validated software controls.
Performance
Performance was validated by comparing segmentation accuracy against manual segmentations and predicate software using Dice Similarity Coefficient scores. Tests confirmed safety and accuracy of bone segmentation without unintended segments, demonstrating substantial equivalence to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/3/2024
8 months - 2
FDA Approval
3/20/2025
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