# Intended Use & Safety Statement

## Current status (v0.1)
Sulcora Planner is **research software**. It is **not** a medical device and is
**not** intended for clinical, diagnostic, treatment, or intraoperative use. It
must not be used to make decisions about the care of any patient. Outputs
(trajectories, distances, angles, reconstructions) are for engineering
development and research only and have not been clinically validated.

Sample imagery is the open **MNI152** reference template, not patient data.

## Intended use of the *future, validated* product (forward-looking)
The product Sulcora is being built toward is a **neurosurgical planning aid**
intended to help a qualified neurosurgeon visualise patient MRI and plan a
stereotactic trajectory (entry, target, approach angle) with quantified proximity
to critical structures, as an adjunct to — not a replacement for — clinical
judgement and established planning/navigation systems.

Any such use is contingent on the validation in `VALIDATION_PLAN.md`, appropriate
regulatory clearance, and integration with cleared navigation hardware where
applicable. Autonomous or robotic actuation is **out of scope** for the initial
product and is gated behind separate, substantially higher safety and regulatory
requirements.

## Data handling
For research, use only de-identified imaging under an appropriate IRB protocol
and data-use agreement. Do not load identifiable PHI into this research build.

## Disclaimer
This document is engineering/clinical-research planning material, not regulatory
or legal advice. Regulatory strategy must be confirmed with qualified regulatory
professionals and the relevant institutional offices.
