OMB Individually Reported

Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial

High riskExact public inventory row

Description

Alignment System Cranial is intended to support the surgeon in planning and achieving a trajectory with surgical instruments during cranial stereotactic procedures. The indications for use are biopsy of intracranial lesions and placement of stereoelectroencephalography (SEEG) electrodes.

Detailed example

This Machine Learning (ML) based functionality is used as an aid in the registration step (in surface matching) by allowing a pre-registration based on guide points (which are delivered by this algorithm). This pre-registration step is not mandatory.

AI / analytics pattern

Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

Automation level / stage

c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

Expected benefit

Accelerate surgery planning workflows.

Controls / human review

ATO: Not reported; PIA: Not published