Question

Requirements and references

MDF4550 §3.5

As it pertains to lines 1, 16, and 21 from R-TF-028-011:

The maximum severity assigned is 4 (pre- and post- mitigation). It is unclear why these risks could not result in potential harms of severity 5 to the patient.
For lines 1 and 16, it is unclear if there are also relevant design mitigations (e.g. if image quality is poor, is this rejected, etc) or relevant instructions for the user. If so, it is unclear how these have been verified to be effective.
It is unclear occurrence rates are estimated based on available data (e.g. from PMS or literature).
It is unclear if residual risks remain for these risk lines, and if so, where these have been communicated to users in the IFU.

Please clarify and justify the above points. For occurrence, please provide any relevant data to support these estimates.