# Residual Risks

# Data Privacy and Integrity

• The input data expected by the Relu® Engine is categorized as personal/private data and must be treated in accordance with local market legislation (e.g., GDPR in the European Economic Area, HIPAA in the US).

# Anatomical Limitations

• The Medical Device must be limited to the anatomies supported by the Relu® Engine.
• Requirements must be specified to reduce the risk of using unsupported anatomies as far as possible.

# Cloud Version and Webhook

• If the Medical Device uses the cloud version of the Relu® Engine with the webhook interface, risk control requirements must be implemented. Specifically, the Medical Device should set a webhook callback timeout of 60 minutes, after which the job is assumed to have failed, to prevent indefinite waiting periods.

# User Training and Information

• End users of the Medical Device must receive adequate training on the limitations of the proposals generated by the Relu® Engine.
• The accompanying Instructions for Use (IFU) must provide clear communication regarding these limitations.

The warnings could be but are not limited to:

	The proposals provided by Relu® Engine are informational and must be assessed by clinical staff using the Medical Device.
	The Medical Device must be verified and validated using input data that is representative of the expected intended use of the Medical Device.