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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  • FDA AI-DSF lifecycle guidance: DRAFT (Jan 2025) — not for implementation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

ProofPack docs

ProofPack is a command-line tool that takes one CSV of model predictions plus a criteria.yaml you author, and writes an evidence attachment set to disk. It runs where you run it. The FDA draft guidance on AI-enabled device software functions (January 2025), not for implementation, is the guidance its FDA templates are mapped to; the guidance status is stated on every page of this site.

These docs are built alongside the site, in the same repository and the same deploy, and describe the engine as it stands — version and dates are on the changelog. Engine 0.1.0.dev1 stops after ingest and the HALT gates; the quickstart, criteria.yaml, HALT gates, version comparison, billing and IQ/OQ pages each name that version beside the sentences that describe later engine work.

Sections

Section titled “Sections”
  • Install — pip and Docker, Windows, and proofpack doctor.
  • Quickstart — doctor, then map, then run; exit codes; what is written.
  • criteria.yaml — every block and field, and which of them you must author because ProofPack sets no default.
  • Schema and mapping — the canonical columns, the missing-value tokens, mapping confidence and the --yes rule.
  • HALT gates — H01 to H12, what each inspects, and what to change. Each code has a fixed address here for the CLI and the lifecycle emails to use; the CLI line does not print it yet.
  • Version comparison — proofpack compare, pairing on row_id, and the test-set ledger.
  • Egress and --offline — the exhaustive field list for every channel that can leave your network, the suppression thresholds, and data-use agreements.
  • Billing — card via Stripe Checkout, or quote then invoice on net-30 terms with a PO; renewal; the grace watermark.
  • T12 IQ/OQ pack — what the pack contains and what it is for.
  • Methods FAQ — the statistical methods, seeded from the engine’s fixture register.
  • Scope, Support, Changelog.

Stable anchors

Section titled “Stable anchors”

Every HALT code has a fixed address on the HALT gates page — /docs/halt-gates#h01 through #h12 — and the pages above carry fixed section ids for ProofPack’s own messages and emails to link to (the CLI does not print them yet, measured 15 September 2026). They are listed in the site repository at src/data/anchors.json and a build test fails if any of them stops resolving.