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ProofPack docs
  • FDA AI-DSF lifecycle guidance: DRAFT (Jan 2025) — not for implementation
  • PCCP guidance: final (Dec 2024, updated Aug 2025)
  • FDA Statistical Guidance on diagnostic tests: final (2007)
  • Guidance map v1

Scope, in the docs

The authoritative list of what ProofPack deliberately does not do is the scope page — permanently out of scope, not “not yet” — with the guidance map and the dated public roadmap. This page is the short form for a reader who arrived from a pack or an email, and it says the same thing.

What the engine says about itself

Section titled “What the engine says about itself”

Every pack carries a scope statement written by the engine’s scope.py, not by a template author. Its short form, filled at render time with the engine version, the run date and the guidance references, reads:

Statistical output generated by ProofPack v{version} on {date} from customer-supplied data and customer-declared criteria (author/date in Run Manifest). ProofPack does not verify data provenance, labelling accuracy, reference-standard validity, sampling or study design, and does not select acceptance criteria, thresholds or margins. Narrative sections are machine-drafted and must be reviewed by the manufacturer’s qualified statistician and regulatory lead before use. Guidance references: {guidance_refs}. This output is not a regulatory opinion; no regulator has endorsed this tool.

The long form, “Scope and limits of this document”, has eight items: what ProofPack is; what is warranted (computational correctness of the numbers to the stated tolerances on the reference platform); what is the manufacturer’s responsibility; what is out of scope; guidance status; narrative; the conventions that are ProofPack’s and not a regulator’s; and synthetic or demonstration data.

Out of scope, never performed by ProofPack

Section titled “Out of scope, never performed by ProofPack”

Study design; sample-size calculation; selection of acceptance criteria, margins or thresholds; adjudication and reference-standard construction (rater columns are never used to construct labels); MRMC and reader studies; clinical-outcome evidence; literature review; valid clinical association; benefit-risk; risk management; cybersecurity documentation; human factors; explainability; complaints and vigilance; incident trend reporting; 510(k) Summary authorship.

If a question on the support channel asks for any of these, the answer is that ProofPack does not do it, with a pointer to this list. That is not a limitation the roadmap will lift.

Guidance status

Section titled “Guidance status”

The FDA draft guidance on AI-enabled device software functions (January 2025), not for implementation, is the guidance the FDA templates are mapped to. Every guidance reference in a pack names the document, its version or date and whether it is draft or final, and the status strip at the top of every page on this site states the same three lines. ProofPack’s guidance map is versioned and updates when the guidance does; a pack records the map version it was rendered with.

Synthetic, demo and trial marks

Section titled “Synthetic, demo and trial marks”

A document marked SYNTHETIC - illustrative, DEMO or TRIAL contains no real evidence and must not be used in any regulatory record. The marks are the engine’s constants and appear in the title and on every page of such a document.