Build 843 Freeze Delta and Study-Build Designation¶
Updated: 2026-09-08
| Field | Frozen source | Build 843 IDE submission build |
|---|---|---|
| Source identity | ide-software-freeze-2026-08-21 / 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e |
walkabout-candidate-2026-08-21-build-843 / 1455cda7ad5d3e164b4a955ea0e3bc725a9996e9 |
| Product version/build | Freeze source baseline | BionicLoop 1.0 (843) |
| Environment | Frozen engineering source | CC-DEV compiled Scout service environment; supportive service only, with no effect on local dosing |
| Archive SHA-256 | Not applicable | 80449b03c92dbc6aa21b5f255722522757f767ee84d303ab3af2b3b86f836ac0 |
| Status | Exact-freeze execution complete | Build 843 approved for IDE submission 2026-09-03; evidence and traceability accepted 2026-09-07 EDT |
1. Executable Delta Assessment¶
The source comparison from the frozen baseline to Build 843 identified these build-relevant changes:
| Change | Assessment |
|---|---|
Controlled app-workspace Package.resolved added at SHA-256 019b5768cfb4fc5c4c3c27106b7df9d60e0d7988eed34a3e75f4e523c625eded |
Pins CryptoSwift 1.10.0, SlideButton, and SwiftCharts exactly for reproducible archive resolution |
Config/Build/Base.xcconfig and Debug.xcconfig placed under source control |
Configuration-identification correction; Build 843 values are retained at SHA-256 ed7d66f263f626e94e703538945ad63852b1792fbb739ee936c5e59ac38f9e2c and df4c78aa7ea8c5e7f0d2a4981e17dcbf1bc856ddce5671f918767f384a12a792 |
| OmniBLE CryptoSwift requirement changed from a version range to exactly 1.10.0 | Dependency-control change; no pump protocol or command behavior changed |
OmniBLE test source changed from .bytes to .byteArray |
Test compatibility only; no shipped implementation change |
No BionicLoop app, BionicLoopCore, G7SensorKit, LoopKit, OmniBLE production Swift implementation, or Algo2015 C++ behavior changed between the frozen source and Build 843. The remaining comparison changes are documentation, evidence, scripts, and package records.
2. Verification Reuse Assessment¶
| Evidence | Reuse assessment |
|---|---|
Frozen algorithm, app, simulation, and TV-SEC-001 execution |
Behaviorally applicable because no shipped runtime implementation changed; accepted for Build 843 under D08 |
| Build 843 dependency checks | Directly applicable to Build 843 |
| Build 843 OmniBLE cryptographic/session tests | Directly applicable to Build 843 |
| Build 843 Core, canonical app, and security suites | Directly applicable to Build 843 |
| Build 843 installed identity, real-Pod use, and exact-session recovery ZIP | Working/supporting evidence; accepted claim boundary must be recorded |
| RA-023 multi-device intended-sensor replacement | Not established by current Build 843 working evidence. The September 3 adversarial review records CGM-screen manager-reset, concurrent-candidate, automatic-trigger-isolation, and first-reading-use limits. Sponsor/Clinical must decide whether unchanged Build 843 may proceed after objective testing and residual-risk acceptance or whether a corrected post-submission build is required before participant deployment; no discrimination claim is made before completion. |
If a different archive, source commit, dependency resolution, signing identity, or environment is designated, this assessment must be repeated and the affected verification identified before participant installation.
3. Study-Build Designation¶
Build 843 was approved for IDE submission by controlled correspondence on
2026-09-03. Controlled correspondence references below replace handwritten
signatures for this software-package record. The accepted D06 disposition
retains the controlled RA-023 exercise as a pre-deployment condition.
| Decision field | Sponsor entry |
|---|---|
| Designated participant study build (version/build) | BionicLoop 1.0 (843) |
| Source tag/commit | walkabout-candidate-2026-08-21-build-843 / 1455cda7ad5d3e164b4a955ea0e3bc725a9996e9 |
| Archive SHA-256 | 80449b03c92dbc6aa21b5f255722522757f767ee84d303ab3af2b3b86f836ac0 |
| Intended service environment | CC-DEV, internal study/tester environment |
| Signing/distribution identity | Retained in Appendix A10A release record |
| Accepted reused evidence | Completed at D08 closure |
| Required targeted reruns before use | Completed at D08 closure |
| Effective date | 2026-09-03 |
| Approval | Name/signature | Date |
|---|---|---|
| Sponsor/clinical approval | Camille Powe, MD; controlled correspondence | 2026-09-03 |
| Software technical review and final package approval | Edward R. Damiano, PhD; controlled correspondence | 2026-09-07 EDT |
| Clinical/study operations / service environment | Tara Bresnahan, RN; controlled correspondence | 2026-09-04 |
CC-DEV is compiled into Build 843 through CC-DEV.xcconfig. Scout is a
supportive service and does not affect local dosing. A different service
environment requires a new build identity and corresponding delta assessment.
Participant-environment confirmation is closed under D12 in the IDE
Submission Decision Register.