Table of Contents

Using the System

Intended Use

Brainlab Elements SmartBrush provides an easy interface with tools and views to outline structures in patient image data. The output is saved as 3D DICOM segmentation object and can be used for further processing.

Indications for Use

Brainlab Elements SmartBrush can be used in all clinical workflows that require to outline anatomical structures in patient image data. The device itself does not have specific clinical indications.

Intended Use Environment

Elements SmartBrush shall be used in:

  • Office environments within hospitals or at any other location offering a computer
  • Rooms appropriate for surgical interventions

A more specific intended use environment (e.g., a specific planning station or navigation platform) may be present when the device is used in combination with other devices.

Intended User Profile

The application is intended to be used by medical professionals and their assistants with a need to outline structures in patient image data.

In addition, typical users are:

  • Neurosurgeons and ear-nose-throat (ENT) surgeons
  • Healthcare professionals educated for the planning and execution of neurosurgery procedures. Segmentation is an optional step in these use cases.
  • Neuro/Ortho/Spine/Trauma surgeons
  • Medical professionals trained for radiation therapy treatment. More specifically, radiation oncologists or dosimetrists for organ at risk outlining

Intended Patient Population

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

In addition, typical patient populations are:

  • All patients/all ages where a reference to a rigid anatomical structure can be established
  • Patients with specified indications and relevant modality scan data available

Intended Part of the Body or Type of Tissue Applied to or Interacted With

As the device is software only it does not interact with any body parts or tissue.

The outlining, review and refinement of anatomical structures is not limited to any body part, i.e. that image sets of any body part can be imported and used in the aforementioned way.

For Spine SRS treatment, additional functionality is provided to further facilitate the treatment planning workflow.

Plausibility Review

Art-No. 60919-79EN

Date of issue: 2019-12-05