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IDE Software Verification Summary

Status: Exact-freeze engineering execution complete Updated: 2026-09-08

Frozen Baseline

ide-software-freeze-2026-08-21 at 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e; last shipping-product commit ae00e754.

Exact-Freeze Lanes

Lane Current result Remaining action
STP-ALG-001 Behavioral pass; exact-freeze static-analysis/linkage companion passed 6/6 ALG-DEV-SA-006 closed
STP-AUTO-001 app target 997 total, 996 passed, 1 intentional IFU reference-table generation helper skip gated by an export directory, 0 failures Accepted under D08
STP-AUTO-001 UI target Original run: 41 passed, 3 reproducible test-harness deviations; corrected serial companion: 44/44 passed AUTO-DEV-001 and AUTO-DEV-002 closed
STP-SIM-001 Pass Accepted under D08
TV-SEC-001 68/68 scoped local controls passed Accepted under D08 and D09
Build 843 IDE submission archive Dependency controls 6/6; OmniBLE crypto/session 8/8; Core 471/471; app 997 executed with 996 passes, 1 intentional IFU reference-table generation helper skip gated by an export directory, 0 failures; scoped security 68/68; signed archive, installed identity, real-Pod operation, and exact-session recovery export recorded as working evidence Approved for IDE submission 2026-09-03; evidence accepted under D08

Designated Build Supplement

Build 843 uses an exactly resolved dependency set and passed dependency and cryptographic verification. Archive/build identity, installation, and physical operation are available in Appendix A10B. Build 843 was approved for IDE submission by controlled correspondence on 2026-09-03.

Traceability

The canonical RTM 1.86 maps exact-freeze evidence to all 24 IDE-scope risk-analysis rows. It distinguishes automated coverage from retained hardware, alert, clinical, cloud, and policy decisions.

Deferred Physical and Operator Evidence

STP-HW-001 and supplemental STP-ALERT-001 are not retained as separate formal IDE claims. Real-Pod formative observations remain supporting evidence, consistent with the 2026-08-27 clinical approval.

Formal Versus Working Evidence

Formal evidence is a controlled bundle explicitly classified under Evidence/Formal/. Working evidence and historical candidate runs may support investigation and rationale but do not close the frozen-baseline claim unless accepted through the sponsor-approved evidence process.

Verification Disposition

Verification evidence and traceability are accepted under D08; residual risk is accepted under D07; cybersecurity scope and controls are accepted under D09. The controlled multi-G7 exercise remains a predeployment condition under D06 and is not represented as completed verification.

Clinical approval on 2026-08-27 records the supportive Scout role, official study sources, no-separate-formal-hardware-validation claim boundary, and human-factors evidence description.

The IDE Freeze Execution Report controls if this summary conflicts with detailed evidence.