AI-510(k)-Assistant

App Files

Application executable: Media: AI-510(k)-Assistant.zip

Settings.txt

CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)

AI-ContextInfo: // Prompt that provides contextual information for the subject new device related to the submission

AI-510kContentPrompt: // Prompt that instructs how to analyze provided data to generate submission content.

AI-510kSourceDocuments: // Prompt that provides source content to extract relevant information for submission content, which may include 510k summaries of similar devices/predicate, particular performance standards, previous regulatory correspondence, FDA forms for classification, design history files, etc.

AI-WordsPerReport: // Number of words in each intermediate report (recommended: 1500, range: 100-5000)

AI-ModelTemperature: // LLM Temperature index (recommended: 0.05, range: 0..1f)

AI-ModelTopP: // LLM TOP_P index (recommended: 0.4, range: 0..1f)

AI-ModelTopK: // LLM TOP_K number of words for next word prediction (recommended: 10, range: 1-128)

AI-ModelMaxOutputTokens: // LLM maximum output words (range: 1-2048)

See the sample files page for example templates.

Sample Files: AI-510(k)-Assistant

App Description

App Use Case: The AI-510(k)-Assistant is designed to simplify the process of preparing 510(k) submissions by automating content creation in compliance with electronic submission requirements for eSTAR. It serves as a valuable tool for medical device companies seeking FDA clearance for their devices. By utilizing information from 510(k) summaries of predicate devices and similar products, the AI-510(k)-Assistant streamlines the compilation of necessary documentation and data, facilitating faster submission processes and reducing administrative burdens.

App Functionality: The AI-510(k)-Assistant employs an intuitive interface to guide users through the submission process. It begins by extracting relevant data from predicate device summaries and identifying similarities with the device under review. Users are then prompted to input specific details about their device and intended use. Based on this information, the Assistant generates submission forms and documents tailored to meet regulatory requirements. Users can review and customize the generated content to ensure accuracy and completeness before final submission.

Key Features:

Automated extraction of information from predicate device summaries Customized generation of submission forms and documentation Streamlined workflow to accelerate the submission process Comprehensive coverage of regulatory requirements for 510(k) submissions User-friendly interface with intuitive navigation and customization options Diagram outlining the processing steps of the AI-510(k)-Assistant:

The AI-510(k)-Assistant simplifies and expedites the preparation of 510(k) submissions, helping medical device companies navigate the regulatory landscape with confidence and efficiency.