Medical & Clinical Disclaimer

This is research software — not a medical device. No CE mark, no FDA clearance. All results require physician verification.
1. Research Software — Not a Medical Device

YASAFlaskified and psgscoring are research software, intended exclusively for use by qualified professionals (physicians, researchers, registered polysomnographic technologists) in a research or clinical research context.

This software has not been evaluated, cleared, or approved by any regulatory authority as a medical device, including:

  • European Union Medical Device Regulation (EU MDR 2017/745) — no CE mark
  • U.S. Food and Drug Administration (FDA 21 CFR Part 820 / 510(k)) — no FDA clearance
  • Any equivalent national or regional medical device framework
2. Not a Substitute for Clinical Judgement

All computed indices — including AHI, OAHI, ODI, PLMI, arousal index, and RDI — are research-grade estimates. They must be:

  • Reviewed by a qualified, licensed clinician before any diagnostic or therapeutic decision
  • Validated against manual scoring by a registered polysomnographic technologist (RPSGT)
  • Interpreted in the context of the full clinical picture and patient history
3. Intended Use
✓ Designed for:
  • Academic sleep research
  • Algorithm development and benchmarking
  • Clinical research under ethics committee approval
  • Educational purposes in sleep medicine
  • Second opinion and screening
✗ NOT designed for:
  • Standalone clinical diagnosis without expert review
  • Automated treatment decisions
  • Unsupervised patient screening programmes
  • Any setting where output directly determines patient care
4. Validation Status

External validation on the PSG-IPA dataset (PhysioNet, 5 recordings, 47 independent scorer sessions) demonstrated mean |ΔAHI| = 1.9/h and severity concordance of 4/5 (80%). PSG-IPA.

A formal single-centre validation study (n≥50) is in preparation. Until peer-reviewed results are published, all outputs should be treated as preliminary and verified by a qualified clinician.

5. No Warranty

THIS SOFTWARE IS PROVIDED "AS IS", WITHOUT WARRANTY OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT. IN NO EVENT SHALL THE AUTHORS BE LIABLE FOR ANY CLAIM, DAMAGES OR OTHER LIABILITY.

psgscoring v0.38.0 · YASAFlaskified v0.39.3 · April 2026
Full DISCLAIMER.md on GitHub