OTOPLAN
Cascination AGOTOPLAN is software that helps otologists and neurotologists visualize, segment, and analyze medical images such as CT and MRI scans to assist in planning and assessing ear-related surgical procedures like cochlear implantation. It provides tools for 3D reconstruction, electrode visualization, and image fusion, enhancing surgical planning accuracy and patient outcomes.
Intended Use
OTOPLAN is intended to be used by otologists and neurotologists as a software interface allowing the display, segmentation, and transfer of medical image data from medical CT, MR, and XA imaging systems to investigate anatomy relevant for the preoperative planning and postoperative assessment of otological and neurotological procedures (e.g., cochlear implantation).
Technology
OTOPLAN is a standalone software platform (Software as a Medical Device) for medical image display, manual and automatic segmentation, measurement, 3D reconstruction, and image fusion. It supports CT, MR, and X-ray imaging modalities to enable analysis and planning of otological and neurotological surgeries. It includes new functions such as fluoroscopy and plain X-ray viewing, electrode contact identification, implant visualization, and advanced automatic 3D reconstructions using statistical shape modeling and geometry-based algorithms.
Performance
OTOPLAN underwent extensive software verification and validation, human factors and usability testing, and formal internal test standards. Performance validation included quantitative evaluation of image segmentation, thickness mapping, cochlear parameter estimation, and image fusion accuracy using clinical CT and MR datasets annotated by expert surgeons. The device met predefined acceptance criteria for accuracy and usability, demonstrating safety and effectiveness without requiring clinical studies.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/19/2024
8 months - 2
FDA Approval
4/11/2025
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