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IDE Software Prior Testing Summary

Status: Reviewer summary Owner: BionicLoop engineering Last updated: 2026-04-07 12:32 EDT

Purpose

Summarize the current body of prior software testing that supports the investigational baseline, without requiring reviewers to start from the full RTM or detailed STP/STR library.

Current Evidence Shape

The current software package already has broad engineering evidence across:

  • unit tests for core algorithm-host, runtime policy, alerting, persistence, and safety behavior
  • app-side unit tests for Home, meal, BG, CGM, pump, and alert workflows
  • targeted UI tests for critical operator flows
  • STP ownership documents for algorithm, automation, simulation, hardware, and alert drill lanes
  • controlled trace chain linking risk, requirements, design, verification rows, and review evidence

What This Means For IDE

For this packet, the useful claim is:

  • there is already a substantial prior engineering test body supporting the accepted local software baseline
  • the remaining work is not to invent new verification structure, but to trim and promote the right subset into the formal frozen IDE evidence set

Areas With Strong Existing Development Coverage

  • runtime wake-cause and degraded-mode behavior
  • meal announcement and manual BG workflow handling
  • alert normalization, acknowledgement, and notification behavior
  • clinical settings gating and applied-configuration behavior
  • major Home/pump/CGM workflow rendering and state transitions

What Still Needs Freeze-Time Promotion Or Audit

  • RTM rows still marked In progress, Partial, or Pending
  • final audit of which rows are truly claimed in the IDE packet
  • formal promotion/rerun of specific high-risk or in-scope rows, including TV-SEC-001
  • final baseline SHA capture for the frozen evidence set

Reviewer Guidance

This packet should be read as:

  • evidence that the software package has meaningful prior engineering verification depth already
  • not yet a claim that every detailed RTM row is formally closed for the frozen IDE baseline

The freeze-time task is to carry forward only the evidence needed for the accepted packet scope.

Primary Support References