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IDE Software Submission Review Hub

Last updated: 2026-09-04

This page provides the reading order for the BionicLoop IDE software package. The formal engineering baseline is frozen at ide-software-freeze-2026-08-21 commit 91c0e98a. BionicLoop 1.0 (843) commit 1455cda7 is approved for IDE submission and has a retained signed archive, installed-build identity, automated verification, real-Pod use, and walkabout evidence. IFU-BL-001 revision 1.17 was approved on 2026-09-04, and the ZIP/CSV collection, transfer, and storage process was approved on 2026-09-03.

Study Team Software Document Review

The September 3 protocol, consent, and device-labeling candidates were reviewed against Build 843. The protocol's material software descriptions and the labeling's Build 843 / IFU 1.16 identity is retained exactly. A synchronized device label naming IFU 1.17 is tracked under D14. Final document issuance, consent control, and FDA/IRB handling remain with the study team. The source files are not published on this site. Study-team reviewers may use:

  1. Review Directions
  2. Software Consistency Crosswalk
  3. Reviewer Response Sheet

These are software-consistency and handoff records, not FDA submission attachments.

Reviewer Reading Order

  1. Core Manifest
  2. Integrated Core Narrative
  3. Technical Appendices Manifest
  4. Instructions for Use

Downloadable Packages

Current Engineering Record

  • Exact-freeze algorithm, app, simulation, and scoped cybersecurity execution is complete.
  • The three execution deviations were closed by controlled companion evidence.
  • The RTM maps execution evidence to all 24 IDE-scope risk-analysis rows.
  • Build 843 records its exact source, dependency, archive, upload, installation, real-Pod, and recovery-ZIP identities.
  • Build 843, IFU revision 1.17, and the ZIP/CSV operating approach are approved for the IDE submission.
  • September 3 clinical-document candidates were reviewed for software consistency; final nonsoftware document control is tracked separately.

Study Team Closeout

Use the Decisions and Acceptance Memo as the action sheet. Supporting closeout records are:

The repository remains the controlled source for internal planning, raw evidence, and historical records. Those internal materials are intentionally excluded from this review site.