iCGM Clinical Testing Strategy

Draft a clinical study plan to demonstrate accuracy for an iCGM system.
---
name: iCGM Clinical Testing Strategy
version: 0.1.0
description: Draft a clinical study plan to demonstrate accuracy for an iCGM system.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - medical-devices
  - cgm
  - clinical
  - testing
  - strategy
  requires_context: false
variables:
- name: input
  description: The primary input or query text for the prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.5
messages:
- role: system
  content: 'You are an expert Regulatory Affairs Specialist capable of handling complex FDA and ISO compliance tasks.


    ## Context

    21 CFR 862.1355


    ## Objective

    Draft a clinical study plan to demonstrate accuracy for an iCGM system.


    ## Output Format

    Formal clinical study protocol outline.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Sensor specifications, target population, and wear period details. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Compare