This standard specifies comprehensive requirements for the performance and safety evaluation of Artificial Intelligence (AI)-based Smart Mandibular Advancement Devices (Smart MAD) for sleep apnea treatment. The standard • establishes a clear definition and technical taxonomy for Smart MAD; • defines performance evaluation criteria for biosignal sensor accuracy, active actuator responsiveness, and control algorithms; • specifies mechanical and biological safety requirements, including fail-safe mechanisms for patient protection; • describes clinical validation procedures for linking AI-based auto-titration functions with clinical indices such as Apnea-Hypopnea Index (AHI) and peripheral oxygen saturation (SpO₂); and • defines data models, communication protocols for interoperability between devices and cloud services, and cybersecurity requirements specialized for medical devices.
- Standard Committee
- EMB/Stds Com - Standards Committee
- Status
- Active PAR
- PAR Approval
- 2026-06-04
Working Group Details
- Society
- IEEE Engineering in Medicine and Biology Society
- Standard Committee
- EMB/Stds Com - Standards Committee
- Working Group
-
AIMD-MAD - Artificial Intelligence Based Smart Mandibular Advancement Devices
- IEEE Program Manager
- Christian Orlando
Contact Christian Orlando - Working Group Chair
- Kyeongseong Seo
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