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IDE Software Verification Summary

Status: Reviewer summary Owner: BionicLoop engineering Last updated: 2026-06-03 09:00 EDT

Purpose

Show the current verification posture for the IDE software packet at a level suitable for review planning.

Current Verification Posture

Area Current Posture Freeze-Time Need
Core runtime and algorithm-host behavior Structured unit/integration coverage exists and is already mapped into the controlled quality chain. Keep only the rows actually claimed for IDE and promote their evidence into the formal freeze set.
Device integration and alerting behavior App-side tests and supporting protocol ownership exist for CGM, DASH, and normalized alert behavior. Audit claimed rows and rerun/promote only the accepted IDE-scope evidence.
Masked fallback reconnect recovery Candidate baseline coverage confirms credible same-pod pump-delta accounting as no-command missed-step primary/secondary algorithm replay with CGM=-1, per-step delivered-insulin input, and no duplicate recovered delivery on the resumed live step; unknown pod identity or delivery-history discontinuity suppresses fallback-basal replay and continues the same session unreconciled. Known different/new pod still suppresses fallback-basal replay, while any pending automatic issued-dose attribution from the prior pod is handled under the assumed-delivered clinical policy. Promote or rerun the claimed rows into formal freeze evidence if masked fallback recovery remains in the IDE claim set.
No-active-pod alerting Candidate baseline coverage confirms repeat safety-critical notification attempts while the no-active-pod condition remains true. Promote or rerun alert evidence for the claimed alert rows in the formal freeze lane.
Critical operator workflows Targeted UI and app-level regression coverage exists for Home, meal, BG, settings, alerts, and related workflows. Carry forward only the workflows that materially support study use.
Cybersecurity export/file handling Review notes, checklist, and engineering recommendation exist. Execute and promote TV-SEC-001 at freeze.
Detailed RTM closure Structure is in place, but many rows are still marked In progress or reference working evidence. Complete the packet-scope RTM audit and stop claiming working-lane evidence as closure evidence.

Verification Rule

For this packet, verification should be considered sufficient when:

  • accepted IDE-scope behaviors are clearly identified
  • each claimed behavior has a credible verification path
  • freeze-time evidence promotion is limited to the claimed subset

This packet does not require:

  • formal trace closure for deferred scope
  • formal promotion of verification lanes not being claimed for this packet

Current Blocking Verification Items

  1. RTM evidence audit into formal-ready, rerun-needed, and deferred
  2. final formal execution/promotion for the claimed rows still lacking freeze-ready evidence
  3. replacement of working-lane references in any row still being claimed

Current Candidate-Baseline Evidence Notes

  • LoopRuntimeCoordinatorFallbackReplayTests pins missed-step pump-delta algorithm replay rows with CGM=-1, per-step delivered-insulin input, primary/secondary telemetry, and no duplicate recovered delivery on the resumed live step.
  • FallbackBasalExposureReconcilerTests pins same-pod credible pump evidence, stale/missing evidence, different/new pod suppression, unknown pod suppression, and rollback/history-discontinuity handling.
  • BionicLoopRuntimeEngineMaskedFallbackMaintenanceTests pins first-arm remask failure recovery-state preservation.
  • BionicLoopAlertCenterRuntimeTests pins no-active-pod repeat notification behavior and use of latest active condition details.
  • Full core and app unit suites passed for candidate baseline review, but formal IDE closure still requires freeze-lane evidence discipline.

Primary Support References