Skip to content

BionicLoop IDE Software Package

Field Value
Status Frozen engineering baseline; exact-freeze execution complete
Baseline tag ide-software-freeze-2026-08-21
Baseline commit 91c0e98a9bc9429a0486bebdebffc7d8dbbe300e
Last shipping-product commit ae00e754
Last updated 2026-09-08

Reviewer Front Door

Start with the IDE Software Submission Core - Manifest. The Core gives a concise description of the investigational software, scope, risk posture, verification status, known limitations, human-factors evidence, labeling reference, and open decisions.

Detailed design-control material is organized by the IDE Software Technical Appendices - Manifest.

Package Structure

1. FDA-Facing Core

2. Controlled Technical Appendices

3. Study Team Document Handoff

Use the Software Document Review Directions, Software Consistency Crosswalk, and Reviewer Response Sheet for the final software-consistency result. The final protocol, consent, and device labeling have been checked against Build 843. These records are published for study-team use but are not part of the FDA-facing Core or Technical Appendices.

Use the IDE Submission Decision Register for the authoritative approval record and the RA-023 predeployment condition. The Decisions and Acceptance Memo provides the corresponding plain-language handoff. Internal planning, command sheets, raw working evidence, and historical records remain in the controlled repository and are not published on the review site.

Current Status

Exact-freeze execution is complete:

  • STP-ALG-001: behavioral pass; the exact-freeze linkage companion passed 6/6 and closed ALG-DEV-SA-006
  • STP-AUTO-001: 997 app tests, 996 passed, one intentional IFU reference-table generation helper skip gated by an export directory, zero failures; the original UI run recorded 41 passes and three harness deviations, and the corrected companion passed 44/44, closing AUTO-DEV-001 and AUTO-DEV-002
  • STP-SIM-001: pass
  • TV-SEC-001: 68/68 scoped local controls passed
  • Build 843 uses an exactly pinned and tracked dependency resolution; automated verification, signed archive, upload with symbols, installation, real-Pod operation, and an exact-session recovery ZIP are recorded.

RTM version 1.86 maps execution evidence to all 24 IDE-scope risk-analysis rows. The supportive Scout boundary, official study-data sources, physical-use claim boundary, human-factors evidence description, and fingerstick protocol direction were clinically approved on 2026-08-27. Clinical approval to implement all eight software-consistency recommendations was recorded on 2026-08-31. Build 843 and use of the recovery ZIP for CSV collection, transfer, and storage were approved on 2026-09-03; IFU revision 1.17 was approved on 2026-09-04. The final protocol, consent, and synchronized device labeling completed software-consistency review. The RA-023 submission disposition, residual-risk acceptance, verification-evidence acceptance, cybersecurity acceptance, and final software-package approval are closed. The controlled multi-G7 exercise remains required before first participant deployment.

PDF Outputs

The package provides two external outputs:

  • IDE_Software_Submission_Core.pdf
  • IDE_Software_Technical_Appendices.pdf

The External Submission Attachment Manifest controls the proposed external file set, hashes, and retained evidence locators.

The existing IDE_Software_Packet_Review_Binder.pdf remains an internal compilation and is not the reviewer front door.

Evidence Rule

Only controlled evidence explicitly classified under Evidence/Formal/ is formal execution evidence. Working evidence remains supporting material unless the sponsor-designated review approver accepts it for a stated submission claim.

The internal Engineering Completion and Organizational Handoff is the plain-language action sheet for the larger study team. It is not part of the FDA-facing narrative.