IDE Formal Evidence Index - 2026-08-21¶
| Field | Value |
|---|---|
| Baseline | ide-software-freeze-2026-08-21 / 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e |
| Execution status | Complete |
| Organizational status | Evidence and traceability accepted under D08; cybersecurity scope and controls accepted under D09 |
| Updated | 2026-09-08 |
Formal Lane Index¶
| Evidence bundle | Result | Open item |
|---|---|---|
Evidence/Formal/STR-ALG-001/2026-08-21-ide-freeze-alg-baseline-r2/ |
Behavioral verification passed; Algo2015 line coverage 96.12%, branch coverage 87.77%; bridge line coverage 90.27%, branch coverage 65.85%; total-insulin host regression passed | Original execution retained; ALG-DEV-SA-006 closed by the companion below |
Evidence/Formal/STR-ALG-001/2026-08-25-sa-006-linkage-companion/ |
Exact-freeze static-analysis/linkage companion passed 6/6; literal frozen SHA matched one review record and two SRS IDs | ALG-DEV-SA-006 closed |
Evidence/Formal/STR-AUTO-001/2026-08-21-ide-freeze-auto-baseline-r2/ |
App target 997 total / 996 passed / 1 intentional IFU reference-table generation helper skip gated by an export directory / 0 failed; UI target 41 passed / 3 reproducible harness deviations | Original execution retained; AUTO-DEV-001 and AUTO-DEV-002 closed by the companion below |
Evidence/Formal/STR-AUTO-001/2026-08-25-ui-harness-companion/ |
Corrected test-harness-only serial UI run passed 44/44 | AUTO-DEV-001 and AUTO-DEV-002 closed |
Evidence/Formal/STR-SIM-001/2026-08-21-101509-14034-ide-freeze-sim-baseline/ |
Core, pod, alert, and real-engine simulation lanes passed | Accepted under D08 |
Evidence/Formal/STR-SEC-001/2026-08-21-ide-freeze-tv-sec-001/ |
68/68 scoped local controls passed | Accepted under D08 and D09 |
Evidence/Formal/STR-SEC-001/2026-08-21-ide-freeze-sbom-advisory-manual/ |
Composition, binary identity, source credential-pattern review, and controlled manual advisory evidence generated | Accepted within the cybersecurity scope under D09 |
Evidence/Formal/STR-SEC-001/2026-08-21-ide-freeze-cryptoswift-1.9-companion/ |
Archive-matching companion passed 68/68 scoped security, 8/8 OmniBLE crypto/session, 9/9 app unlock, and 19/19 core unlock tests | Historical archive-826 impact evidence; CYBER-DEV-001 closed 2026-09-03 by Build 843 designation |
The archive-826 dependency mismatch is retained here as immutable execution
history. CYBER-DEV-001 closed on 2026-09-03 when Build 843, using the
controlled CryptoSwift 1.10.0 resolution, was designated as the IDE submission
build. Build 843 dependency, archive, installation, and supporting real-Pod
records are in Appendices A08A and A10A-C. Evidence and cybersecurity
acceptance are recorded under D08 and D09 without rewriting the archive-826
history.
RTM Coverage¶
The canonical current-state matrix in RTM version 1.86 maps exact-freeze
evidence to all 24 IDE-scope risk-analysis rows (RA-001 through RA-024).
Evidence, traceability, residual risks, and cybersecurity scope are accepted
under D07 through D09. The controlled multi-G7 exercise remains a
predeployment condition under D06. The three previously open clinical policy
questions are confirmed in Appendix A13A.
Evidence Classification¶
- Formal evidence: a controlled bundle under
Evidence/Formal/explicitly executed against or linked to the frozen baseline. - Working evidence: development output not promoted into a controlled formal bundle. It may support investigation but is not formal evidence.
- Physical/operator evidence: formal only after the retained protocol, installed build, subject/device, operator, UTC window, result, signature, and sponsor-designated acceptance are complete.
The Freeze Execution Report is the authority if a summary conflicts with an individual bundle.