Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)
Mighty Oak MedicalAcorn 3D Software is an advanced medical imaging software that processes CT and CTA scans to visualize, segment, and create detailed 3D digital models of musculoskeletal and craniomaxillofacial anatomy, including spine regions. It offers machine learning-based automatic segmentation for certain vertebrae and semi-automatic/manual tools for other bones. Clinicians can use these digital models for measurement, treatment planning, and can also produce physical 3D printed replicas for diagnostic purposes, enhancing surgical planning and patient care.
Intended Use
Acorn Segmentation is intended for use as a software interface and image segmentation system for the transfer of CT or CTA medical images to an output file, including measuring and treatment planning. The output can be used to fabricate physical replicas (3D printed models) for diagnostic purposes in musculoskeletal and craniomaxillofacial applications.
Technology
The software imports DICOM medical images, allows viewing and verifying images and segmentations, selects regions of interest using generic and anatomy-specific segmentation tools including machine learning-based automatic segmentation for thoracic and lumbar vertebrae, plus semi-automatic/manual tools for other musculoskeletal and craniomaxillofacial bones. It calculates and edits digital 3D models, includes measurement tools, and exports models for use or 3D printing. The 3DP Model is a physical replica fabricated by additive manufacturing from the digital model.
Performance
Software verification and validation were performed including end-user and bench testing. The geometric accuracy of digital models was evaluated with Dice-Sorenson coefficients exceeding 0.93 for automatic, semi-automatic, and manual segmentation methods compared to predicate devices. Physical 3D printed replicas were confirmed to have less than 1mm mean deviation compared to digital models, demonstrating substantial equivalence and accuracy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/19/2023
6 months - 2
FDA Approval
7/12/2024
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