수면다원검사기기 개발 및 평가 지원을 위한 디지털도구 개발
Information
| 일자 | 2026년 05월 07일 |
|---|---|
| 저자 | 김영돈 |
| 학술대회 | 제67회 대한의용생체공학회 계학술대회 |
Video
Overview
We developed the Sleep Analysis Algorithm Evaluation Tool (SAAET), a web-based Medical Device Development Tool for regulatory validation of sleep medical device algorithms. SAAET integrates a unified database of 19,171 polysomnography records from eight public cohorts, supporting 50 input channels and 122 output parameters. Users submit Python-based algorithms, which are executed in an isolated virtual environment; performance is evaluated against expert-annotated gold standards and compiled into a regulatory-grade report with non-inferiority testing and subgroup analyses. SAAET improves the efficiency of pre-clinical validation and represents, to our knowledge, the first MDDT framework in the sleep domain.