Clinical Evaluation Use Case
The Clinical Evaluation use case structures the clinical evaluation of your device: clinical benefits, outcome parameters and claims, the state of the art and similar or equivalent devices, and the literature search. All relations are directed: the source Knowledge Topic shows the column, the target is only referenced.
Knowledge Topics
The use case is active once your product contains these Knowledge Topics:
- Clinical Benefits
- Clinical Outcome Parameters
- Claims
- State of the Art
- Similar/Equivalent Device(s)
- Search Execution
- Search Objectives
These Knowledge Topics are optional. Add them to your product to enable the relations that use them:
- Harm
Relationships
The diagram shows how the Knowledge Topics of this use case are connected. An arrow points from the source to the target Knowledge Topic. An arrow with two arrowheads marks a bidirectional relationship.
Each row is one trace column on the source Knowledge Topic. Allow Multiple shows whether a record can be linked to more than one target record. Bidirectional relations are also shown on the target Knowledge Topic.
| Source Knowledge Topic | Relation Name | Target Knowledge Topic | Allow Multiple | Bidirectional | Description | Additional Fields |
|---|---|---|---|---|---|---|
| Clinical Benefits | Linked Claim | Claims | Yes | No | Select the Claims that this Clinical Benefit substantiates. | Claim Name |
| Linked Outcome Parameter | Clinical Outcome Parameters | Yes | No | Select the Clinical Outcome Parameters that measure this Clinical Benefit. | Parameter | |
| Clinical Outcome Parameters | Linked Claim | Claims | Yes | No | Select the Claims that this Clinical Outcome Parameter substantiates. | Claim Name |
| Linked Harm | Harm | Yes | No | Select the Harms that are the clinical consequence if this Clinical Outcome Parameter's acceptance criterion is not met. | Clinical Consequence if Acceptance Criterion not met, Severity | |
| State of the Art | Linked Device | Similar/Equivalent Device(s) | No | No | Select the Similar/Equivalent Device that this State of the Art entry benchmarks. | Device |
| Search Execution | Objectives Addressed | Search Objectives | Yes | No | Select the Search Objectives that this Search Execution addresses. | Objective |
Additional Fields are extra columns that show a field of the linked record, such as the severity of a linked Harm.
Integration with Other Use Cases
Knowledge Topics that belong to more than one use case connect those use cases. This use case shares Knowledge Topics with:
- Risk Management – Harm
- Summative Evaluation – Harm
- Usability Engineering – Harm