Using the System

Intended Use

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

Indications for Use

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 Patient Population

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

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

As the device is software only and allows processing and visualizing data for medical procedures 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.

Intended User Profile

The application is intended to be used by medical professionals and their assistants working in the field of neurosurgery/-radiology, spine and trauma and radiotherapy planning.

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. The intended use environment is then stated in the technical file of the corresponding system.

Plausibility Review

Article No. 60917-66EN

Date of publication: 2018-07-17