AB fda-510k-substantial-equivalence-memo
Use this skill when a medical-device regulatory-affairs specialist or RA manager needs to draft the Section 10 Substantial Equivalence Comparison for an FDA 510(k) under 21 CFR Part 807. Produces a DRAFT intended-use comparison, technological-characteristics table, DQSE analysis, and predicate-eligibility audit for RA / QA review before FDA submission.
Use this skill when a medical-device regulatory-affairs specialist or RA manager needs to draft the Section 10 Substantial Equivalence Comparison for an FDA…
As a process B 68/100 · Nearly there — weak spots: when it triggers, inputs and preconditions, running it twice
How to improve
- Your own cases (evals/evals.json, 4–6 real requests with expected answers): the full check would then run those instead of a model-drafted suite.
- A spec.yaml with trigger phrases and assertions — a behaviour contract for CI; `skilltest init` writes a template.
Guard findings · 0
✓ No critical or high findings
Files scanned: 4. Evidence is masked. Grey chips explain why severity was lowered.
Against the Agent Skills spec
✓ No remarks against the Agent Skills spec
Process rating: all ten parameters 68/100
- 0Inputs and preconditions. Does not say what the process needs to start
- 20When it triggers. No condition that starts the skill
- 30Running it twice. 1 mutating operations with no state check
- 55Failures and branches. 1 branches
- 70Execution cost. Instruction body is 4150 tokens
- 85Steps. 64 steps, 3 vague phrases
- 100Tools and files. No external tools needed
- 100Result and completion. Output format and completion criterion are stated
- 100Consistency. Name and required fields are in place
- 100Progress reporting. Reports progress
- medium Safety rules and hard prohibitions inside a skill: they belong in the system prompt, here they protect nothing
Everything here is measured from the skill text rather than judged by a model, so the numbers are checkable. A parameter weighs more when it is a more common reason for the process to stall.
Quality signals
- +5Description has no quoted example phrases that should trigger the skill
- +4Description does not say when NOT to use the skill (false activations)
- +1No license
- +2Single-language instructions
- +3Description length 354: enough signal without eating the budget
- +4Structure: 13 headings
- +3Step-by-step instructions: 64 items
- +3Output format is stated explicitly
- +4Has examples (2 code blocks)
Quality base 70; lint remarks subtract, signals add up to 100. Result: 87.