BionicLoop IDE Software Documentation¶

This protected site is the review surface for the BionicLoop IDE software package. It separates the concise reviewer narrative, controlled technical appendices, and the limited decisions the study team must record before final submission assembly.

Start Here¶

Study Team Software Document Review¶

For the current protocol, consent, and device-labeling consistency review:

The source protocol, consent, and labeling PDFs are not published on this site. They remain with their controlled document owners. These review pages are study-team working records and are not proposed FDA submission attachments.

Controlled Software Identity¶

Item	Identity
Frozen engineering baseline	`ide-software-freeze-2026-08-21` / `91c0e98a`
IDE submission build	BionicLoop `1.0 (843)` / `1455cda7`
Approved IFU	`IFU-BL-001`, revision 1.17

The frozen baseline anchors the formal engineering execution. Build 843 is the later signed archive with controlled dependency resolution, installation, real-Pod use, and walkabout evidence. Build 843 was approved for IDE submission on 2026-09-03, and IFU revision 1.17 was approved on 2026-09-04.

Package Sections¶

IDE Software Core¶

The concise narrative covers the device software, scope, risk controls, cybersecurity, verification, known limitations, human factors, labeling, and submission decisions.

Technical Appendices¶

The appendices contain the SRS, SDD, Risk Analysis, SVVP, RTM, cybersecurity records, evidence index, configuration identification, IFU, and change-control procedure.

Study Team Closeout¶

The decisions and acceptance memo collects the remaining build, evidence, protocol-control, labeling, and package-acceptance actions in one place. The Scout role and official study-data sources were clinically approved on 2026-08-27.

Site Boundary¶

Internal planning files, task boards, command sheets, raw working evidence, and historical development records remain controlled in the repository but are not published or indexed on this review site.