CLINICAL SaMD DIAGNOSTIC-THERAPEUTIC CYCLE
Patient Journey Architecture
From raw electrophysiological signals through ABR/BERA verification to patient-oriented VR biofeedback environments.
STEP 01SaMD VALIDATED
1. Telemetric qEEG Scan
19-CH /// 500 Hz /// ICA Artifact Clean
Non-invasive 19-channel neuronal activity recording (10-20 system, 500 Hz / 1024 Hz). Muscle and blink artifact elimination via Independent Component Analysis (ICA).
STEP 02SaMD VALIDATED
2. AI Feature Extraction & Entropy
CNN-LSTM /// SHAP XAI /// TBR Ratio
Hybrid Convolutional-Recurrent networks (CNN-LSTM) extract Welch's Power Spectral Density (PSD) and Tsallis/Lempel-Ziv entropy metrics for objective Cz TBR evaluation.
STEP 03SaMD VALIDATED
3. ABR/BERA Differential Diagnosis
ABR/BERA Screening /// Vision Audit
Integration with sensory deficit exclusion protocols (Auditory Brainstem Response ABR/BERA and vision audit) before clinical decisions.
STEP 04SaMD VALIDATED
4. VR Therapy & Neuroplasticity
VR Eyetracking /// EDA Biofeedback
Personalized social skills training in a Sensory Overload Safety environment with biometric eyetracking, EDA biofeedback, and bridging strategies.