TraumaCad Neo (1.1)
Brainlab Ltd.TraumaCad Neo (1.1) is software that helps surgeons plan and evaluate orthopedic procedures by using X-ray images. It overlays measurements and prosthesis templates to assist in surgical planning and postoperative assessment, including automated analysis of hip arthroplasty outcomes using AI. This streamlines workflow and supports clinical decisions prior to and after surgery.
Intended Use
TraumaCad Neo is indicated for assisting healthcare professionals to analyze orthopedic conditions and to plan orthopedic procedures by overlaying on relevant radiological images visual information such as measurements and prosthesis templates.
Technology
Software application enabling surgeons to evaluate digital X-ray images for pre-operative surgical planning and post-operative assessment. Features include automatic AI-based landmark detection and implant presence identification on total hip arthroplasty images, interactive prosthetic template overlay, compatibility with DICOM and healthcare data platforms, and operation on PCs, Macs, iPads, and Android tablets.
Performance
Performance testing used a dataset of 349 pelvic X-ray images augmented to over 1000 images, including diverse patient demographics and implant types. The AI models achieved 99% accuracy in implant presence detection and 92% accuracy in landmark identification within 4mm of ground truth, demonstrating acceptable performance for intended use.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/11/2024
5 months - 2
FDA Approval
6/4/2025
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