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SystemAIS-002Medical device and SaMD

Triage Note Summariser

Summarise free-text triage notes for the reviewing nurse. Non-diagnostic.

Device class
Not a medical device
Status
In development
State
In progress
Owner
Cirocco Jones
Record completeness
72

100, less 12 for each open blocker and 4 for each warning. It measures the record, not the performance of the AI System.

Blockers
2

Two duties are answered on this page. The record must state what produced a result · EU AI Act Annex IV(2)(b) to (g) for the development process, data and training method, and ISO/IEC 42001 A.6.2.6 for the verification of an AI system. And the result must be re-derivable by someone who did not build it, which is what FDA Good Machine Learning Practice asks of a model whose performance is claimed.

Where this AI System stands
Every model version here names the commit, the environment, the parameters and the exact dataset versions that produced it.

Ledger

One entry per AI Model Version. An entry is written when the version is frozen, and it is corrected only with a stated reason.

No model versions yet.

Source repository

The connection that binds a model version to the code that produced it. Events awaiting a governance response come first.

No repository is connected. Without one, the commit on each entry below is stated by hand and nothing checks it against the code.