OTOPLAN

OTOPLAN is a software-as-a-medical-device (SaMD) platform used by otologists and neurotologists for preoperative planning and postoperative assessment of ear and skull base procedures. It displays, segments, and transfers medical image data from CT, MR, and X-ray imaging systems, allowing users to measure anatomical structures, plan surgical trajectories, and assess cochlear implant electrode positioning.

The subject device (version 3.1) adds eleven new functions compared to the predicate (version 2.0): four with same technological characteristics (fluoroscopy/X-ray viewer, manual electrode contact identification on plain X-ray, implant placement visualization, and lead/housing identification) and seven with different characteristics (automatic temporal bone, skin, and inner ear segmentation with thickness mapping; automatic cochlear parameters; automatic Scala tympani/vestibuli segmentation; and image fusion). Both run on Windows operating systems and are standalone software that does not control other medical devices.

AAMI/ANSI/IEC 62366-1:2015 (usability engineering for medical devices); FDA guidance on device software functions (June 2023, basic documentation level); DICE similarity coefficient for algorithm validation; rigorous internal testing with known-dimension datasets and comparison to manually measured ground truth by three qualified surgeons.

The subject device has the same intended use, indications for use, and general technological approach (standalone DICOM viewer with segmentation and measurement tools) as the predicate device. Although eleven new functions are introduced, four employ the same technological principles already in the predicate. The seven different technological characteristics (automatic segmentation algorithms and image fusion) were each validated through formal testing using DICE coefficients, thickness measurements, and landmark distance comparisons against surgeon-established ground truth, with all results meeting predefined acceptance criteria. Human factors testing with 20–15 U.S.-based participants per user group confirmed the subject device is as safe and effective for its intended users and use environments as the predicate.