IDE Software Baseline Overview¶
Status: Reviewer summary Updated: 2026-09-08
Frozen Baseline¶
| Item | Identity |
|---|---|
| Engineering freeze tag | ide-software-freeze-2026-08-21 |
| Full source commit | 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e |
| Last shipping-product commit | ae00e754 |
| Marketing version | 1.0 |
| Exact-freeze execution | Complete |
| IDE submission build | Build 843, designated 2026-09-03 |
| Evidence and residual-risk acceptance | Approved 2026-09-07 EDT |
The baseline is immutable for the current software package. Documentation-only package changes after the tag do not alter the executable. Any product source, algorithm input, build configuration, or dependency-resolution change requires a new configuration identity and an impact-based rerun decision.
Software Under Review¶
- BionicLoop iPhone app user interface and orchestration
- BionicLoopCore runtime, domain, persistence, and algorithm-host logic
- two symbol-isolated compilations of the same unmodified Algo2015 source for primary and safety-controller tracks
- LoopKit support code
- G7SensorKit and G7SensorKitUI for Dexcom G7 integration
- OmniBLE for Omnipod DASH integration
- protected local telemetry, active-session step evidence, and clinical-gated recovery export
Investigational Operating Model¶
BionicLoop receives accepted Dexcom G7 readings or eligible fingerstick BG input, executes algorithm-driven dosing, and commands an Omnipod DASH. Meal announcements, BG entry, device state, alerts, Clinical Settings, Temporary Target, insulin suspension/resumption, and recovery evidence are supported by the frozen app. There is no manual test-dose path.
Dexcom remains the primary CGM alarm source. Study staff perform initial configuration; subsequent Clinical Settings changes use a subject-scoped offline unlock. The software supports programmed backup basal and bounded reconciliation during communication or CGM interruptions.
Execution Status¶
- algorithm behavioral verification passed with one documentary linkage deviation
- automated app tests completed with no app-target failures and three reproducible UI harness deviations
- simulation passed
- 68/68 scoped local cybersecurity controls passed
- Build 843 uses an exactly tracked dependency resolution, passed automated verification, has installed real-Pod supporting evidence, and was designated as the IDE submission build on 2026-09-03. Evidence acceptance was recorded on 2026-09-07 EDT.
- all 24 IDE-scope risk-analysis rows have exact-freeze execution evidence mapped
Evidence acceptance, residual-risk decisions, cybersecurity scope, and final software-package approval are closed. The controlled protocol, synchronized device labeling, IFU, supportive Scout scope, official study sources, physical-use claim boundary, and human-factors evidence description have recorded study-team dispositions. The controlled multi-G7 exercise remains a predeployment condition.