326
edits
AI-510(k)-Assistant: Difference between revisions
m
no edit summary
(Created page with "==App Files== <blockquote> Application executable: Media: AI-510(k)-Assistant.zip </blockquote> ---- 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 devi...") |
mNo edit summary |
||
| Line 4: | Line 4: | ||
Application executable: [[Media: AI-510(k)-Assistant.zip]] | Application executable: [[Media: AI-510(k)-Assistant.zip]] | ||
</blockquote> | </blockquote> | ||
---- | {| role="presentation" style="min-width:250px;" class="wikitable mw-collapsible mw-collapsed code-sample" | ||
| <strong>Settings.txt</strong> | |||
|- | |||
| | |||
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) | |||
|} | |||
</blockquote> | |||
See the sample files page for example templates. | See the sample files page for example templates. | ||
| Line 25: | Line 48: | ||
[[Image: AI-510(k)-Assistant-Process.jpg|600px]] | [[Image: AI-510(k)-Assistant-Process.jpg|600px]] | ||
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. | 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. | ||