aprevo® Digital Planning

aprevo® Digital Planning is a surgical planning software that processes 3D spine models to generate surgical plans for spinal corrections and anatomical measurements. It is intended for use by trained, medically knowledgeable design personnel to assist in planning procedures for skeletally mature patients.

The subject device offers semi-automatic landmark placement and surgical plan generation algorithms, whereas the predicate device required manual placement and operations. Both devices use DICOM input files and produce surgical plan outputs for internal Carlsmed personnel use.

Not stated in this summary.

The devices are substantially equivalent because they share identical regulatory classification, product code, and intended clinical use despite a process difference: the subject device automates landmark determination and surgical plan generation through algorithms, while the predicate relies on manual operations. Performance testing demonstrated the subject device's plans were 90% equivalent to manually-created plans with 90% confidence, confirming functional equivalence. The software development, verification, and validation procedures comply with FDA guidance for software in medical devices.