수면다원검사기기 개발 및 평가 지원을 위한 디지털도구 개발


Information

일자 2026년 05월 07일
저자 김영돈
학술대회 제67회 대한의용생체공학회 계학술대회

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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.

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