ce-to-510k
Skill1 starsChanged 49 days agoNo licenceView on GitHub
Port CE Mark / UKCA medical device technical documentation into an FDA 510(k) submission package for AI/ML SaMD (Software as a Medical Device). Use when a user (typically a non-US medical device manufacturer with existing MDR / IVDR / UKCA technical files) wants to (1) plan a 510(k) submission, (2) identify and analyse a predicate device using FDA databases, (3) draft a Q-Submission (pre-sub) request, (4) map CE Mark documents to the FDA eCopy section structure, or (5) anticipate the AI/ML-specific deficiency questions FDA will ask. Built from real 510(k) clearance experience for an AI/ML imaging device, including the Additional Information / Interactive Feedback cycle. Triggers on "510k", "510(k)", "FDA submission", "pre-sub", "Q-sub", "predicate device", "substantial equivalence", "CE to FDA", "MDR to FDA", "AI/ML 510k".
We split this skill into the rules it gives an agent
8 rules. About 0 are common, 7 are distinctive, and 1 is very specific to this project.
≈0
Common · estimate
Many files like this have a rule of this kind.
≈7
Distinctive · estimate
This author's own choices. Worth a look.
1
Very specific
Tied to their project's names, files or tools. Probably skip.
No licence file, so all rights are reserved — read it at the source. We count its rules but don't quote them. Read them on GitHub.
≈ “Common” is an estimate: at least 1 in 5 of the 308,232 skill files we read have a rule of the same kind, not the same words. “Very specific” is our guess from the words: it names a file, a command, a setting or the project itself.
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