# ProofPack

> ProofPack runs the subgroup, calibration and version-comparison statistics that
> FDA's draft AI-device guidance (AI-DSF, January 2025 — draft, not for
> implementation) describes, inside your own environment, and renders
> them as DOCX/HTML/JSON attachments a regulatory affairs lead can file. You
> declare the acceptance criteria; ProofPack computes and records.

Built by Global Phoenix Solutions Ltd (England and Wales, company no. 14855822).
Site: https://proofpack.globalphoenix.co.uk

## What it is not

No regulator has endorsed ProofPack, and no clearance yet cites it. Evidence gets
reviewed; tools do not get "accepted". ProofPack does not do: study design;
sample-size calculation; selection of acceptance criteria, margins or thresholds;
adjudication or reference-standard construction; MRMC/reader studies;
clinical-outcome evidence; literature review; valid clinical association;
benefit-risk; risk management; cybersecurity documentation; human factors;
explainability; complaints/vigilance; incident trend reporting; 510(k) Summary
authorship.

## Guidance status

- FDA AI-enabled device software functions lifecycle guidance: DRAFT (January 2025) — not for implementation.
- Predetermined Change Control Plan guidance: final (December 2024, updated August 2025).
- FDA Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests: final (2007).

## Pages

- [Home](https://proofpack.globalphoenix.co.uk/): what ProofPack computes and refuses to compute.
- [Scope and roadmap](https://proofpack.globalphoenix.co.uk/scope): permanent out-of-scope list, guidance map v1, dated roadmap.
- [How it works](https://proofpack.globalphoenix.co.uk/how-it-works): the engine runs inside your environment; what may leave, and when, is one table generated from the engine's egress schema.
- [Docs](https://proofpack.globalphoenix.co.uk/docs): install, quickstart, criteria.yaml, input schema and mapping, HALT gates H01-H12 (stable anchors /docs/halt-gates#h01 to #h12), version comparison, egress and --offline, billing, the T12 IQ/OQ pack, methods FAQ, scope, support, changelog.
- [Pricing](https://proofpack.globalphoenix.co.uk/pricing): plans, card checkout and quote-to-invoice, in USD per regulated model.
- [Trust and security](https://proofpack.globalphoenix.co.uk/trust): the exhaustive egress table generated from the engine's egress schema, the security assurances we do NOT hold, sub-processors, retention, continuity, and the public licence-verification key.
- [Validation of the validator](https://proofpack.globalphoenix.co.uk/trust/validation): every fixture, cross-check and review the engine is held to. As of 10 September 2026 every row on it is PENDING, because the engine's CI does not publish its test artefact yet. Nothing on that page should be read as a result.

## Not built yet

/demo, /methods, /tools/subgroup-ci-calculator, /data/fda-ai-device-list and
/sample-pack are scheduled before the 30 September 2026 deploy and are not
linked until they exist.