Ortho AI
Ortho AI LLCOrtho AI is a medical software device that helps orthopedic surgeons by using AI to semi-automatically measure lengths, angles, and implant positions on radiographic images. It assists in preoperative and intraoperative planning for hip, knee, and lumbar spine surgeries through digital annotations and measurements, improving surgical planning accuracy and efficiency.
Intended Use
Assist in making measurements for total hip arthroplasty, total knee arthroplasty, and lumbar spine fusion surgery, by measuring lengths, angles, and position of implants relative to bone structures on x-ray images.
Technology
Software as a medical device (SaMD) using AI/ML models to perform semi-automated, interpretable landmark detection and measurement on preoperative radiographic images of the pelvis, knee, and spine. Provides digital annotations editable by the user, outputs measurements in an HTML format, and supports image input in JPEG, PNG, BMP, and DICOM formats. Can also receive intraoperative images from fluoroscopic c-arm devices via direct connection.
Performance
Performance was validated using a dataset of thousands of images from adult patients, with ground truth established by experienced orthopedic surgeons. The models achieved a Dice coefficient > 0.85 on all connected domains, and measurements showed no statistically significant difference compared to human measurements, with degree or millimeter differences within clinically acceptable limits. Testing included subgroup analyses across different x-ray machine types and anatomical regions, supporting accuracy and reliability of the AI system.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/12/2024
6 months - 2
FDA Approval
1/2/2025
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