02 · EVID · VECTOR · WORKBENCH
Clinical evidence · CER v17
Evidence sealed 02 May · 847 patients · 22 sites · 24-mo follow-up
Agent reasoning trace · VECTOR
SAP v3 locked · primary endpoint AF detection sensitivityf12b…77e0
22 Apr 10:30 SGTDSMB packet 04 cleared · no findings · no haltd45a…c901
28 Apr 14:00 SGTINC-02-001 escalated to CMO (H. Sato) · classificationa91c…3018
01 May 09:18 SGTEvidence sealed · CER v17 · human sign-off P. Nair3e7c…8b29
02 May 11:08 SGTCER v17 section navigator · 312 pages · sealed
§1 Device description28 pp · sealed
§2 Clinical background54 pp · sealed
§3 Clinical evaluation142 pp · sealed
§4 PMCF plan42 pp · sealed
§5 Risk-benefit46 pp · sealed
DSMB packets
Packet 01 (M6)LOCKED · 7a3c…2018
Packet 02 (M12)LOCKED · 1 amendment
Packet 03 (M18)LOCKED · 1 AE narrative
Packet 04 (M24)CLEARED · d45a…c901
SAP v3
PRIMARY ENDPOINTAF detection sensitivity at 24mo
POPULATIONPer-protocol · 847 patients
STAT SIGN-OFFDr. Lin Wei · 22 Apr
STATELOCKED · f12b…77e0
Governance
Receipt chain
Evidence sealed3e7c…8b29
SAP v3 lockedf12b…77e0
DSMB 04 clearedd45a…c901
Human sign-offs
Priya Nair · Evidence seal02 May · ✓
Lin Wei · SAP sign-off22 Apr · ✓
Priya Nair · DSMB 0428 Apr · ✓
Framework parity
21 CFR Part 11EU MDR Annex XIVISO 14971MDCG 2020-7