Study-Team Software Document Review - Start Here

Field	Value
Purpose	Review the completed final-document software-consistency check
Review scope	Software behavior and software evidence wording only
Estimated review time	15 to 20 minutes
Status	Study-team working review record; not an FDA submission attachment
Date	2026-09-08

What Is Being Reviewed

This record summarizes the review of the final protocol, consent, and device labeling against Build 843. The material protocol behavior and participant-facing software disclosure are software-consistent. IFU 1.17 and the synchronized device label naming 1.17 are approved and verified. This record does not ask the study team to review source code, test logs, or the complete software package.

The source DOCX files are not published on this site. They remain with their controlled document owners. The Software Document Consistency Crosswalk records the reviewed source identities and verified software wording.

Review Steps

1. Read the crosswalk summary and completed SW-01 through SW-11 results.
2. Confirm that the final document filenames, dates, and hashes match the submission copies.
3. Use the decision register for the software-package approvals and predeployment condition.

What Reviewers Are Confirming

Reviewers are confirming that the written study documents accurately describe:

• fingerstick use and meal availability during CGM interruption
• Standard and Pregnancy targets, including Temporary Target
• the supported participant-weight range
• the Same-Participant Reset used for the Phase 3 transition
• G7 startup/replacement terminology
• official study-data sources and the supporting Scout boundary
• the level of software testing being claimed
• participant-facing software disclosures and software-labeling identity

What Is Outside This Review

This software review does not approve:

• the overall clinical protocol or statistical analysis
• participant eligibility unrelated to software limits
• general consent language unrelated to software operation
• the complete device, manufacturing, monitoring, or investigator package
• the final FDA or IRB change classification
• the final IDE submission

Completion Record

The software-consistency review is complete. The crosswalk and decision register cite the final source identities and closure records.