PeekMed web
Peek Health, S.A.PeekMed web is an AI-powered software system that helps healthcare professionals perform pre-operative planning for various surgical procedures using patients' imaging studies. It operates in 2D and 3D environments with support for musculoskeletal regions and incorporates automated AI models for bone segmentation and landmarking, improving efficiency and accuracy in surgical planning.
Intended Use
PeekMed web is a system designed to help healthcare professionals carry out pre-operative planning for several surgical procedures, based on their imported patients’ imaging studies, with 2D or 3D planning capability.
Technology
Cloud-based software that processes medical images from various sources, performs digital overlap and dimensioning of prosthetic materials, includes AI-powered modules for automated bone segmentation, landmarking, classification and detection in musculoskeletal regions. The system outputs planning reports including images, measurements and textual descriptions.
Performance
Performance testing included verification of implemented features, thorough development, training, testing and external validation of multiple ML models on diverse datasets across CT and X-ray, with acceptance criteria such as DICE >90% for segmentation and accuracy >90% for classification. Independent external validation datasets demonstrated generalizability and performance stability across defined patient and equipment subgroups. Validation tests covered all anatomical areas and planning workflows, confirming safety and effectiveness.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/8/2025
2 months - 2
FDA Approval
3/19/2025
Other devices from Peek Health, S.A.
- PeekMed web2024 • 510K
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