aprevo® Digital Planning
Carlsmed, Inc.The aprevo® Digital Planning software is a semi-automated surgical planning tool used by trained medical personnel. It processes 3D spine models in conjunction with clinician inputs to produce 3D models of spinal corrections and anatomical measurements, which assist surgeons in pre-operative planning for spine surgeries.
Intended Use
The aprevo® Digital Planning software is intended to be used by trained, medically knowledgeable design personnel to generate surgical plans for skeletally mature patients. The device processes a 3D spine model in conjunction with inputs from healthcare professionals to produce 3D models of spinal corrections and anatomical measurements.
Technology
The software offers semi-automatic landmark placement and applies surgical correction operations to generate surgical plans and 3D spinal correction assets based on surgeon inputs. User interaction involves initiating landmarking and surgical plan generation algorithms, differentiating it from predicate manual methods.
Performance
Software verification and validation demonstrate performance according to specifications. Surgical plans generated by aprevo® Digital Planning were found substantially equivalent to manual plans by medically knowledgeable operators with 90% confidence and reliability.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
8/30/2024
3 months - 2
FDA Approval
12/20/2024
Other devices from Carlsmed, Inc.
- aprevo� Digital Segmentation2023 • 510K
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