510(k) Substantial Equivalence Preparation

Draft a substantial equivalence comparison and summary between a subject device and predicate(s) to demonstrate safety and effectiveness.

View Source YAML

---
name: 510(k) Substantial Equivalence Preparation
version: 0.1.0
description: Draft a substantial equivalence comparison and summary between a subject device and predicate(s) to demonstrate
  safety and effectiveness.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - submissions
  - '510'
  - substantial
  - equivalence
  - preparation
  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 Part 807 Subpart E


    ## Objective

    Draft a substantial equivalence comparison and summary between a subject device and predicate(s) to demonstrate safety
    and effectiveness.


    ## Output Format

    Formal 510(k) Summary or Markdown table as per 21 CFR 807.92.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Device description, indications for use, technological characteristics, performance data, and predicate device identification.
    (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Review