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IDE Software Decisions and Acceptance Memo

Status: Internal sponsor decision memo Owner: Sponsor representative, supported by the Software Developer and clinical investigator Last updated: 2026-09-04

Purpose

Record the limited sponsor decisions still needed to close the IDE software handoff. Engineering recommendations below are technical input; the sponsor's authorized representative records the final decisions.

This memo does not ask the study team to repeat decisions already documented in the controlled packet. A qualified person may perform more than one review function, and the sponsor may use an external technical or regulatory consultant when needed.

Current Engineering Record

  • The immutable engineering execution baseline is ide-software-freeze-2026-08-21 / 91c0e98a.
  • BionicLoop 1.0 (843) / 1455cda7 is approved for IDE submission. Its source, signed archive, dependency resolution, upload, installation, real-Pod use, and formative evidence are recorded. Its compiled Scout service environment is CC-DEV; Scout is supportive and does not affect local dosing.
  • The algorithm, automated app, simulation, and scoped security lanes were executed. Their results and limitations are recorded in the freeze execution report.
  • The protected local recovery ZIP is available as primary reconstruction evidence for the covered session. Scout telemetry is corroborating evidence.

Unless the sponsor intentionally expands the submission scope, the Software Developer recommends that the sponsor:

  1. Accept reuse of evidence for unchanged Build 843 behavior, with targeted reruns only where the later build affects a claim or test result.
  2. Confirm or rescore the provisional RA-023 residual rating, decide the controlled multi-device G7 exercise disposition, and accept the remaining residual risks.
  3. Approve the cybersecurity operating boundary and named responsibilities, the controlled-document approval/signatory convention, and CC-DEV as the participant Scout service environment for Build 843.

Decisions To Record

Decision Recommended entry Final decision and rationale Person/date
Evidence reuse or rerun Reuse unchanged evidence; targeted rerun only for affected claims
Residual risk and RA-023 Confirm the provisional score or rescore; record the multi-device exercise disposition
Cybersecurity and service environment Approve the operating controls and confirm CC-DEV, or require a new build identity
Approval record Designate the authorized signatory and approval-reference convention
Software package Accept, or return with specific requested actions

Decisions Already Recorded

The completed clinical decisions are retained in the Clinical Approval of Software IDE Decisions and Final Software Approvals. They include the August 31 approval to implement all eight software-consistency recommendations, Build 843, IFU revision 1.17, and the ZIP/CSV operating approach. They require no repeat clinical decision. Final clean-file verification remains a separate document-control action.

Supporting Records

Handoff Acceptance

Field Entry
Sponsor representative
Date received
Package accepted or returned with specific actions
Signature or controlled approval reference