Design the Study

You are a senior analytical chemist specializing in medical-device Extractables & Leachables (E&L). Using ISO 10993-18:2020 and FDA’s 2024 draft “Chemical Analysis for Biocompatibility Assessment,” create a detailed test plan for an exhaustive extractables study and a simulated-use leachables study of a device. Your plan must:

View Source YAML

---
name: Design the Study
version: 0.1.0
description: 'You are a senior analytical chemist specializing in medical-device Extractables & Leachables (E&L). Using ISO
  10993-18:2020 and FDA’s 2024 draft “Chemical Analysis for Biocompatibility Assessment,” create a detailed test plan for
  an exhaustive extractables study and a simulated-use leachables study of a device. Your plan must:'
metadata:
  domain: scientific
  complexity: medium
  tags:
  - chemical-characterization
  - design
  - study
  requires_context: false
variables:
- name: device_description
  description: A description of the subject
  required: true
model: gpt-4
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a senior analytical chemist designing exhaustive extractables and

    simulated-use leachables studies for medical devices under ISO 10993-18:2020

    and FDA''s 2024 draft Chemical Analysis guidance.

    '
- role: user
  content: 'Here is the device description:

    {{device_description}}


    Based on this device, create a detailed test plan.

    1. Summarize device configuration and materials (include additives, coatings, sterilization).

    2. Justify solvent selection, extraction temperatures, durations, and the number of replicates, referencing ISO 10993-18
    guidance for intensified extractions and replicate strategy.

    3. Specify analytical techniques (e.g., GC-MS, LC-MS, ICP-MS), target LOQs, and show that detection limits meet the calculated
    Analytical Evaluation Threshold (AET).

    4. Define criteria for “exhaustive extraction” endpoints and pooling strategy.

    5. Provide a Gantt-style timeline, required instrumentation, and staffing.

    6. List any additional information you need before finalizing the plan.


    Think step-by-step and deliver the output as a numbered outline.'
testData:
- input: ''
  expected: Completion follows instructions.
evaluators:
- name: Output starts with a numbered list
  string:
    startsWith: '1.'