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IDE Freeze Remaining Work Checklist - 2026-08-21

Status: Active operational closeout checklist; decision status is controlled in the IDE Submission Decision Register Owner: Sponsor/Clinical/Regulatory organizational handoff; BionicLoop engineering supports only disposition-driven changes or reruns Last updated: 2026-09-14

Purpose

Maintain the detailed actions supporting the canonical IDE Submission Decision Register after exact-freeze engineering execution. Decision status and required closure records are authoritative in that register. This checklist applies to engineering freeze tag ide-software-freeze-2026-08-21 at 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e.

The BionicLoop engineering package is handed off. The items below are organizational acceptance, clinical/regulatory, study-operations, or submission activities and are not additional engineering deliverables unless their disposition requires a controlled product/document change or targeted rerun.

Do not close an item from conversation history alone. Record the decision, evidence path, reviewer, and date here or in the linked controlled record. A product or build-input change requires a new freeze identity and an impact-based rerun; document-only acceptance and signatures do not.

Build 1.0 (843) at source 1455cda7ad5d3e164b4a955ea0e3bc725a9996e9 is a later controlled CC-DEV archive approved for IDE submission on 2026-09-03. Its archive, installation, real-Pod operation, and working walkabout evidence are recorded. It is not the same configuration identity as the exact-freeze baseline above; evidence, traceability, and residual-risk acceptance are closed under D07 and D08.

Closeout Items

1. Hardware and supplemental alert scope decision

  • Current status: Complete by clinical approval dated 2026-08-27.
  • Disposition: The package describes real-Pod walkabout use as supporting evidence and does not claim a separate formal hardware-validation study. STP-HW-001 and supplemental STP-ALERT-001 are therefore not retained as separate formal IDE claims.
  • Completion evidence: Clinical Approval of Software IDE Decisions - 2026-08-27.

2. Retained physical/operator verification

  • Current status: Build 843 working evidence is available as supporting evidence; no separate formal hardware-validation claim is made.
  • Execution owner: Assigned operator; engineering performs evidence review; the sponsor-designated review approver accepts the result.
  • Action only if a later submission decision adds a physical claim: Execute only the retained scenarios in the IDE Freeze Operator V&V Packet on the frozen build. Record app/build identity, device and iOS, Pod lot and expiry, CGM identity, subject, operator, UTC/local window, screenshots, and telemetry references. Bench/saline use only where specified.
  • Reuse rule: Existing observations may be used if they identify the exact frozen build and contain enough operator, device, time, and telemetry context. Otherwise rerun only the unsupported retained scenario.
  • Available working evidence: Appendix A10B records Build 843, subject JRC-FORMAL-VV, the UTC/local window, operator observations, deterministic checker output, real-Pod operation, and a hashed exact-session recovery ZIP. Phone model/iOS, operator signature/date, Pod lot/expiry, and CGM identity are incomplete. Pod replacement and same-run G7 replacement were not exercised in that JRC run.
  • Additional staff sheet received 2026-08-31: A Build 843 walkabout dated August 21-27 adds operator observations of ordinary use, meal completion, fingerstick markers, chart dots, relaunch, Pod recovery, a notification, CGM-outage/BG recovery, and Pod replacement. The internal intake record is Internal/IDE_Erin_Walkabout_Receipt_2026-08-31.md. Export was not completed because the operator could not find Share; a brief relaunch "No Pod" display and incomplete drill timestamps remain correlation follow-ups. No new technical insulin-accounting result or RA-023 closure is claimed.
  • Completion evidence if scope is widened: Signed packet pages, attachments, anomaly references, engineering review, and organizational disposition.

3. Exact-freeze deviation disposition

  • Current status: Complete. All three non-product deviations were corrected and rerun through controlled companion evidence.
  • Closure: ALG-DEV-SA-006 passed the exact-freeze static-analysis/linkage companion 6/6. AUTO-DEV-001 and AUTO-DEV-002 passed the corrected complete serial UI companion 44/44.
  • Product impact: None. The changes are limited to review linkage, test-only launch seeding, and UI-test assertions. Original execution records remain unchanged.
  • Completion evidence: Formal Evidence Index.

4. Clinical policy confirmations

  • Current status: Complete. Camille Powe, MD replied "Confirmed" on 2026-08-21 to the request containing all three statements.
  • Decision owner: Clinical review complete; organizational residual-risk approval is carried under item 7 rather than assigned to engineering.
  • Accepted statements:
  • F13 quantization: accepted fallback delivery is allocated over applicable five-minute steps using the backup-basal schedule, quantized to 0.01 U, while preserving the accepted total. This was previously accepted in a meeting and confirmed in writing on 2026-08-21.
  • RES-004: backup basal may engage when current CGM freshness cannot be established as well as when CGM data is confirmed stale. This was confirmed in writing on 2026-08-21.
  • Weight range: the clinical-entry range is 50...500 lb inclusive (22.7...226.8 kg), based on the predicate app. An out-of-range entry cannot arm the algorithm. The host also applies a final 20...230 kg algorithm safety rail.
  • Completion evidence: IDE Clinical Policy Confirmation - 2026-08-21, including the retained source screenshot and SHA-256.

5. IFU controlled review and approval

  • Current status: Complete. IFU-BL-001 revision 1.17 was approved on 2026-09-04, and synchronized 008_Device_Labeling.pdf was received and verified under D14 on 2026-09-08.
  • Decision owners: Sponsor/Regulatory and clinical reviewer.
  • Action: Include the controlled IFU and synchronized device-label attachments in final submission assembly.
  • Boundary: Copy or figure corrections may remain document-only after impact review. A requested behavior change reopens the product freeze assessment.
  • Completion evidence: Approved BionicLoop IFU, revision 1.17, its approval record, and the synchronized device label.

6. Local evidence and cybersecurity closeout

  • Current status: Exact-freeze scoped local controls passed 68/68. Build 843's exact dependency lock, signed archive, installation, real-Pod working observation, and physical recovery ZIP inspection are complete. The Build 843 CycloneDX SBOM and dated license/advisory review are available. Cybersecurity scope, controls, evidence, and the manual review limitations are accepted under D08 and D09. Operational cyber activities remain in the closure matrix.
  • Owners: Engineering has executed and correlated the available evidence; the Sponsor/Regulatory designee and sponsor-designated review approver decide retained scope and accept or defer it.
  • Action:
  • Retain the approved package position that the clinical-gated device-local recovery ZIP is primary software session-reconstruction evidence and Scout is supportive/corroborating backup. Official sources are Dexcom Clarity for CGM outcomes, the BionicLoop exported CSV for insulin-delivery outcomes, and staff-entered electronic CRFs for adverse events and other safety information.
  • The 2026-08-25 recovery ZIP opening is complete as working evidence: it contains the CSV and only the matching Algo2015 session. It ends at 09:33:48 EDT, before later Temporary Target and suspend/resume drills. If a single local export must cover those later rows, obtain one post-run ZIP.
  • Retain the accepted freeze-time software-composition, binary-checksum, manual advisory, and archive-matching dependency-impact artifacts.
  • Use Technical Appendix A08C, the IDE Cybersecurity Closure Matrix, to manage operational G7SensorKit acknowledgment, vulnerability monitoring, update/patch, incident response, and labeling/consent review activities.
  • Signed tester archive 843 records its source tag/SHA, checksum, dependency manifest, archive signing/provisioning identity, successful App Store Connect upload with symbols, installed Build 843 identity, and focused real-Pod working observation. Retain a separate TestFlight group-assignment record if required by the study team's operating records. The archive, dSYMs, export options, and raw upload logs are retained at Git-excluded locator ReleaseArtifacts/Build-843/; organizational promotion or backup remains a larger-team disposition.
  • Keep broader cloud/auth/provider, supplier, Part 11, and commercial cybersecurity closure explicitly deferred unless the Sponsor/Regulatory designee widens the packet scope.
  • Completion evidence: D08 and D09 acceptance records. The Scout scope and official data sources are recorded in the 2026-08-27 clinical approval record. Operational cyber actions do not reopen the software-package approval unless their disposition requires a software or labeling change.

7. Organizational acceptance and RTM disposition

  • Current status: Complete. Build 843 designation was approved on 2026-09-03. Residual-risk, evidence/RTM, cybersecurity, and final software-package acceptance are closed under D07 through D09 and D11.
  • Owner: Sponsor/Regulatory lead and sponsor-designated review approver; engineering supports only document mechanics or an approved targeted rerun.
  • Action: Preserve the approved records and explicit deferrals. A product, build-input, scope, or claim change requires change-control review.
  • Completion evidence: Final software approvals in Appendix A18 and the canonical Decision Register.

8. Final clinical document synchronization

  • Current status: Complete. The final protocol, consent, and device labeling are consistent with Build 843 and their exact identities are recorded in the crosswalk, decision register, and attachment manifest.
  • Completion evidence: Internal record IDE_Clinical_Document_Final_Candidate_Review_2026-09-03.md and final source hashes in the external attachment manifest.

9. RA-023 intended-sensor replacement evidence

  • Current status: Submission deferral accepted under D06. A September 13 Build 843 field observation closes the submitted stuck-on-old-sensor workflow: when the replacement was not advertising, the app retained the working prior G7; after the intended replacement became available, the app adopted it in 35 seconds while the prior G7 remained nearby and active, excluded warmup values, and resumed algorithm use only after reliable data. The broader multi-device exercise is not complete, and no claim is made for rejecting another person's G7. The September 3 adversarial review also identified CGM-screen manager-reset, concurrent-candidate, automatic-trigger-isolation, and first-reading-use limits in frozen Build 843.
  • Owners: The Software Developer and study operations execute and document the bench exercise; the designated clinical/risk approver records the final deployment disposition.
  • Submission action: Complete. D06 accepts unchanged Build 843 for submission subject to the predeployment condition.
  • Pre-deployment action: Before first participant deployment, exercise intentional and producible automatic replacement triggers with the intended and at least one active nearby non-intended G7. Include relaunch, CGM-screen reentry, acquisition-timeout retry, and varied candidate ordering. Demonstrate that staleness does not initiate replacement, and retain operator, device, build, sensor identities, time, candidate presence/order, adopted and processed readings, algorithm input, episode continuity, and result evidence.
  • Current operating instruction: The IFU directs trained study staff to start the intended G7 before scanning, keep the study phone next to it and away from other active G7 sensors during acquisition, and compare BionicLoop status/readings with the intended Dexcom app session after connection. This comparison is a detection control and does not gate the first accepted reading; the instruction does not replace the required pre-deployment exercise.
  • Evidence: Build 843 G7 Replacement Field Observation - 2026-09-13 for the closed reported workflow; D06 approval for submission, followed by the remaining retained exercise record and final RA-023 deployment disposition before first participant deployment.

10. Official insulin-delivery CSV data process

  • Current status: Use of the recovery ZIP for CSV collection, transfer, and storage was approved on 2026-09-03. Appendix A17 records the detailed integrity, access, retention, and chain-of-custody controls. The September 3 final protocol contains the approved official-source hierarchy.
  • Owners: Sponsor/Data Management/Clinical with Software Developer review.
  • Action: Retain Appendix A17 with the final protocol/data-plan and include it in the approved technical appendices.
  • Completion evidence: Final Software Approvals - 2026-09-03 plus matching final protocol/data-plan references.

Weekly Review Rule

Review this checklist at the start and end of each freeze-closeout work period. For every status change, update the canonical decision register and add the evidence path or decision reference and date here; do not delete completed items until the IDE packet is accepted.