# Autocontouring The autocontouring component of {{device_name}} covers the following intended uses: - Clinical decision support within radiotherapy via automated contouring of both target and avoidance structures within the treatment planning workflow. ## Intended Medical Indication ### Used in cases where there is already a clinically implemented contouring protocol For each contour provided by the software to the user, the user needs to be able to validate the contour against the clinically implemented contouring protocol, and if needed, either refine the provided contour to come into alignment with the protocol, or potentially completely redraw the contour. (case-validation)= ### Limited by case validation of the deployed model It is intended that the usage of the model be limited to use within the radiotherapy treatment workflow in cases where the model has been validated for the combination of: - Contours based on the clinically utilised protocol - Patient population demographics such as age group, sex, race and disease state - Imaging region - Patient orientation - Imaging device - Imaging modality - Imaging parameters such as energy, resolution, reconstruction kernels, MRI sequences - Scenario induced imaging artifacts such as metal spinal implants, dental work, metal hips The recommended way to validate that the model appropriately handles the above cases is to collect a representative clinical dataset of the above for model validation, and if necessary a further independent dataset for model refinement. For new models this representative sample can be utilised in unison with the provided tools to readily undergo bulk validation and investigation. For more information on commissioning and ongoing quality assurance of AI models in radiotherapy see the following article: > Liesbeth, V., Michaël, C., Anna, M. D., Charlotte, L. B., Wouter, C., & Dirk, > V. (2020). > [Overview of artificial intelligence-based applications in radiotherapy: Recommendations for implementation and quality assurance.](https://doi.org/10.1016/j.radonc.2020.09.008) > Radiotherapy and Oncology. ## Contraindications Utilisation is to be limited to where the model itself has undergone in-centre validation. See section [](case-validation) for further details. ## Patient Population The patient population is to be limited to where the model itself has undergone in-centre validation. See section [](case-validation) for further details. ## User Profile ### Used by those with appropriate training and knowledge The contours provided by the {{device_name}} software are a recommendation only. When being used to support clinical radiotherapy treatment within Australia these contours are to be provided to a RANZCR certified Radiation Oncologist or an ASMIRT certified Radiation Therapist for subsequent refinement according to that clinic's approved contouring protocols. ### Refined by a relevant health professional and subsequently checked by an independent relevant health professional It is intended that the software results be refined by a relevant health professional and then be subsequently checked by a separate and independent relevant health professional before the patient contours are utilised to create the radiotherapy treatment plan. ### Provides a recommendation only and is not intended to replace clinical judgement The software provides unapproved DICOM-RT Structure set files. These are then sent through to a contour drawing, refining and approval system, either a TPS or a dedicated contouring software system. The health practitioner, either a Radiation Oncologist or a Radiation Therapist, is to use their clinical judgement to decide whether or not refinement is appropriate before approval and whether or not approval is appropriate at all. This clinical judgement is to be informed by the department's published contouring protocols to which the software's recommended contours can be directly compared. The software is not to be used in situations where the software provides recommendations that cannot be corroborated with current published clinical protocols. ## Use Environment Including Software/Hardware For the purpose of autocontouring the {{device_name}} software is to be installed on a local server with one of the following OS types and versions: - Windows >= 10 - Ubuntu LTS >= 22.04 ## Operating Principle When undergoing autocontouring the {{device_name}} software is designed to fulfil the `Contourer` role within the [IHE RO BRTO-II profile](http://ihe-ro.org/doku.php?id=doc:profiles:brto-ii). This is defined as: > A system that consumes [an image series] and creates an RT Structure Set. ... ### To be utilised within the framework of standard DICOM input and output The software is intended to receive DICOM files that conform to the DICOM standard. The software that it provides results to is intended to receive and appropriately handle standards compliant DICOM structure files. It is not intended to directly interface with another medical device except via this standard DICOM input and/or output (either file based or DICOM network protocol based). ### Prompt access to notifications, warnings and alerts Through the dashboard interface users can designate warning and alert thresholds for a range of relevant scenarios. The software itself may also present warnings and alerts. The email address of the user account used to access the software needs to be able to be readily accessed so that these configurable alerts and warnings can provide the appropriate notification.