FDA SaMD 510(k)/De Novo — capability brief.

In scope. clearance pathway for AI/ML device software functions. Cite-anchor: FDA SaMD 510(k)/De Novo.

Out of scope. Production data (no PHI, no PII, no student record, no privileged correspondence). Model weights. Customer's own analyses of the evidence record.

Boundary. Only sha-pinned, Merkle-rooted derived metadata crosses; model state never does. U.S. provisional patent No. 64/073,668 covers the property.

Every measurement against FDA SaMD 510(k)/De Novo lands in a signed evidence record: each artifact carries its own SHA-256, the artifacts chain into a Merkle root, and the engine version is pinned alongside. Internal or external compliance recomputes the root and checks the record — without the model state ever crossing the boundary.

Planisphere measures behaviour, not capability. The evidence record says this is what your fleet did against the probe set; it does not say this is what your fleet will do under adversarial pressure. Adversarial coverage is a scope expansion that adds a probe family; the engine and the record shape do not change.

Reproducibility requires the inputs to be preserved. The record pins the inputs by SHA; it does not host them.

Open the evidence check. Drop ATTESTATION.json and the named artifacts. The browser recomputes each per-artifact SHA-256 and the chained Merkle root via Web Crypto. Files do not leave the tab.

For a synthetic 3-subject record, see how a record is checked: one click checks an intact record; one click checks a tampered record and names the failing file.

Planisphere Corp., FDA SaMD 510(k)/De Novo — capability brief, v0.1, https://www.planisphere.ooo/corpus/fda-samd-510k/brief. Methodology preprint: 10.5281/zenodo.20372606.

Open scoping for FDA SaMD 510(k)/De Novo Reference