IDE Clinical Policy Confirmation - 2026-08-21

Field	Value
Status	Clinical confirmation complete
Requester	BionicLoop Software Developer
Clinical reviewer	Camille Powe, MD
Request date/time	2026-08-21 11:11 EDT
Confirmation date/time	2026-08-21 11:38 EDT
Recorded in package	2026-08-25
Last updated	2026-09-03

Confirmed Decisions

The clinical reviewer replied "Confirmed" to the request containing all three statements below:

1. Backup-basal reconciliation distributes the accepted delivery total across the applicable five-minute steps according to the backup-basal schedule. Individual steps are rounded to 0.01 U while preserving the accepted total.
2. Backup basal may activate when current CGM freshness cannot be established, as well as when CGM data is confirmed to be stale.
3. The participant weight-entry range is 50...500 lb inclusive (22.7...226.8 kg). Entries outside this range prevent the algorithm from starting. The algorithm also applies a final 20...230 kg safety limit.

Source Evidence

• Retained source: clinical confirmation email screenshot
• SHA-256: 026a4da0569c56ff74992ea41bfc99a7bb8ab92f48c88f7402875ff5147b8a2a
• The retained image is a byte-for-byte copy of the supplied email screenshot.

Disposition Boundary

This record closes the outstanding clinical-confirmation request for schedule-weighted fallback quantization, RES-004, and the weight-entry range. It does not change product behavior or formal execution results.

Final IDE submission-build approval was recorded on 2026-09-03. Organizational residual-risk approval and submission signatures are sponsor, Clinical, and Regulatory activities. They are not additional BionicLoop engineering implementation deliverables.