IDE Software Technical Appendices - Manifest¶
| Field | Value |
|---|---|
| Package | IDE Software Technical Appendices |
| Status | Approved controlled technical source set; predeployment condition remains identified |
| Baseline | ide-software-freeze-2026-08-21 / 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e |
| Date | 2026-09-08 |
Use of This Package¶
These appendices provide detailed design-control and verification support for the IDE Software Submission Core. Historical evidence narratives in a controlled source document remain audit history; current execution status is governed by the canonical RTM current-state matrix and Freeze Execution Report.
Controlled Appendices¶
| ID | Artifact | Current identifier/status |
|---|---|---|
| A00 | Enhanced Documentation Level and FDA Content Crosswalk | Enhanced Documentation Level rationale and controlled FDA content map; approved under D11 |
| A01 | Software Requirements Specification | SRS version 1.82; approved for IDE submission |
| A02 | Software Design Description | SDD version 1.84; frozen G7 implementation limits recorded; approved for IDE submission |
| A03 | Risk Analysis | Risk Analysis version 1.53; residual risks accepted under D07; RA-023 predeployment condition retained |
| A04 | Software Verification and Validation Plan | SVVP version 1.91; evidence accepted under D08; RA-023 coverage limits retained |
| A05 | Requirements Traceability Matrix | RTM version 1.86; canonical current 24-row mapping accepted under D08 |
| A06 | Cybersecurity Plan | Cybersecurity Plan version 1.03; Build 843 dependency controls, SBOM, supportive Scout scope, and accepted cybersecurity boundary recorded |
| A07 | Formal Evidence Index - 2026-08-21 | Freeze lane index; execution complete and accepted under D08 |
| A08 | Software Composition and Dependency Inventory | Manual inventory and Build 843 exact dependency evidence accepted within D09 |
| A08A | Build 843 Dependency Verification | Passing engineering evidence for the installed, real-Pod-exercised Build 843 archive approved for IDE submission |
| A08B | Build 843 SBOM and Advisory Review | CycloneDX 1.5 SBOM reconciliation and dated manual license/advisory review accepted within D09 |
| A08C | IDE Cybersecurity Closure Matrix | Study-used cybersecurity controls separated into complete, open, and deferred items |
| A09 | IFU-BL-001, BionicLoop Instructions for Use | Revision 1.17; approved for IDE submission 2026-09-04; supplied separately rather than embedded in the appendix compilation |
| A10 | Software Version and Configuration Identification | Frozen source, algorithm, dependency, toolchain, and document identity |
| A10A | BionicLoop 1.0 (843) Tester Release Record | Signed archive, successful distribution, installed identity, completed working real-Pod observation, CC-DEV boundary, retained-artifact locator, and 2026-09-03 IDE-submission approval |
| A10B | Build 843 Working Hardware Evidence Review - 2026-08-25 | Recovery ZIP, operator record, and corroborating telemetry reviewed as supporting evidence accepted under D08 |
| A10C | Build 843 Freeze Delta and Study-Build Designation | Executable delta assessment supporting the 2026-09-03 submission-build approval |
| A11 | IDE Freeze Execution Report - 2026-08-21 | Engineering execution complete; three non-product deviations closed by controlled companion executions |
| A12 | Post-Approval Software Change-Control and Regulatory-Classification Procedure | Controlled procedure for sponsor/Regulatory approval |
| A13 | Sponsor and Nonsoftware IDE Ownership Map | Ownership/gap map; nonsoftware completion not inferred |
| A13A | Clinical Policy Confirmation - 2026-08-21 | Written confirmation of the applicable fallback and participant-weight policies; clinical policy complete |
| A14 | Cloud Telemetry Submission-Scope Decision | Supportive Scout role and official study-data/safety-report sources clinically approved 2026-08-27 |
| A15 | Protocol Fingerstick Consistency Issue | Closed in the final protocol, consent, and IFU document set |
| A16 | Clinical Approval of Software IDE Decisions - 2026-08-27 and 2026-08-31 | Controlled correspondence record covering seven approved software/IDE statements, official study sources, and approval to implement all eight software-consistency recommendations |
| A17 | Insulin Delivery CSV Data-Management and Chain-of-Custody Procedure | ZIP/CSV collection, transfer, and storage approach approved 2026-09-03; detailed operating controls retained here |
| A18 | Final Software Approvals - September 2026 | Controlled correspondence approving Build 843, IFU revision 1.17, ZIP/CSV operations, RA-023 submission disposition, residual risks, verification evidence, cybersecurity scope, service environment, and final software-package approver |
Formal Evidence Attachments¶
The formal lane directories contain checksums, commands, environment records,
test outputs, and result summaries. Raw .xcresult bundles and console logs are
controlled evidence attachments and are not reproduced in the narrative PDF.
Working evidence is excluded from formal claims unless accepted through the
sponsor-approved evidence process.
RTM Packaging Note¶
The external appendix compilation renders the controlled RTM's current 24-row trace linkage together with the authoritative 2026-08-21 Freeze Execution Overlay. It does not reproduce the source RTM's superseded-candidate evidence and status columns. Those fields remain unchanged in the controlled source and source-control history for internal audit use.
IFU Packaging Note¶
The appendix compilation does not regenerate or embed IFU screenshots. The separately controlled IFU PDF is the labeling attachment. This prevents an appendix build from silently incorporating unapproved screenshot changes.