Table 1.
Critical patient tasks were performed in various scenarios with the test participants, which allowed usability validation and risk assessment of the critical use tasks associated with the ID-Cap System.
| Task ID | Task description |
| PTa01 | Understand key device labeling for patient users |
| PT02 | Power on reader before use |
| PT03 | Set up charging pad and charge reader |
| PT08 | Download and set up app on smartphone |
| PT09 | Pair reader with smartphone |
| PT04 | View, understand and respond to reader indicator light |
| PT05 | Wear reader appropriately to record ingestion event |
| PT06 | Ingest ID-Capsule (alone or co-ingested with medication) |
| PT07 | Wear reader for sufficient time to record ingestion event |
| PT10 | Understand and respond to ingestion confirmations from reader and app |
| PT11 | Understand and respond to reminder notifications from app appropriately; for example, by manually recording an ingestion event that the reader did not record |
| PT12 | View and understand ingestion history in app:
|
aPT: patient task.