PeekMed web
Peek Health, S.A.PeekMed web is a cloud-based software system designed to assist healthcare professionals in orthopedic pre-operative planning. It works with imported imaging studies to create 2D or 3D surgical plans, supporting multiple anatomical regions including hip, knee, upper limb, and foot. It features AI-powered automatic bone segmentation and landmarking to enhance planning accuracy and efficiency, providing a comprehensive surgical overview and reports to clinicians.
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.
Technology
PeekMed web is a cloud-based distributed software system that represents medical images in 2D or 3D, performs measurements, allows template overlays, and uses machine learning models for bone segmentation, landmarking, and classification to support surgical planning. It processes DICOM images from various sources and outputs a report with selected images, measurements, and textual information.
Performance
Nonclinical performance testing including verification, training, testing, and external validation of ML models showed that the updated models meet or exceed acceptance criteria for segmentation, landmarking, and classification, demonstrating substantial equivalence to the predicate device. External validation datasets were independently collected to ensure reliability and generalizability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/4/2024
8 months - 2
FDA Approval
12/6/2024
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