Using the System

Intended Use

Brainlab Elements Fibertracking is an application for the processing and visualization of cranial white matter tracts based on Diffusion Tensor Imaging (DTI) data for use in treatment planning procedures. Brainlab Elements Fibertracking can be used in all clinical workflows that require the visualization of cranial white matter tracts in the brain. The device itself does not have specific clinical indications.

Specifically, Brainlab Elements Fibertracking can be used to visualize white matter tracts in the brain for Cranial Resection, SRS Treatment Planning or Cranial Contouring Cases.

Place of Use

Elements Fibertracking shall be used in:

  • Office environments within hospitals (e.g., clinical planning office) or any other location offering a computer
  • On a Brainlab platform in an operating room/suite or in rooms appropriate for surgical interventions

User Profiles

In general, the application is intended to be used by medical professionals and their assistants working in the field of neurosurgery and radiotherapy planning.

Specifically, typical users as defined in the applicable use case descriptions are:

  • Neurosurgeons, surgeon’s assistants and OR nurses
  • Medical physicist, radiation oncologists, dosimetrists, radiation technologists

Patient Population

There are no demographic, region or cultural limitations for patients.

Plausibility Review

Art-No. 60919-74EN

Date of issue: 2020-02-26