AI-Risk-Assistant
App Files
Application executable: Media: AI-Risk-Assistant.zip
Reference file: Media: openFDA device_search_fields.xlsx
Reference file: Media: openFDA recall_search_fields.xlsx
Settings.txt CONFIG:OpenFDA-Vertex-V1.0 // identifies schema version (readonly)
https_url1: // openFDA api for MAUDE source data
https_url2: // openFDA api for Recall source data
limit1: // limit of MAUDE query results
limit2: // limit of Recall query results
report_title: // title of output report
data1_fields: // data fields to be analyzed in MDR query results
data2_fields: // Data fields analyzed in Recall query results
KEYWORD1-SEARCH: // general keyword search terms for MAUDE (matched in any field)
KEYWORD1-SEARCH: // general keyword search terms for Recall (matched in any field)
SEARCH1-FIELDS:SEARCH1-TERMS // MAUDE query search fields and terms, see openFDA device_search_fields.xlsx for full details of searchable fields
adverse_event_flag: // MAUDE example field
date_received: // MAUDE example field
device.device_report_product_code: // example field
SEARCH2-FIELDS:SEARCH2-TERMS // Recall query search fields and terms, see openFDA recall_search_fields.xlsx for full details of searchable fields
event_date_created: // Recall example field
recalling_firm: // Recall example field
reason_for_recall: // Recall example field
SORT1-FIELD:SORT1-TERM // MAUDE query results sorting date_received:desc
SORT2-FIELD:SORT2-TERM // Recall query results sorting event_date_created:desc
COUNT1-FIELD:COUNT1-TERM // MAUDE query count field/term
COUNT2-FIELD:COUNT2-TERM // Recall query count field/term
AI-ProblemSummaryPrompt: // Prompt that summarizes the product problem
AI-CountSummaryPrompt: // Prompt that counts the instances of items
AI-RecallSimilarityPrompt: // Prompt that analyzes the similarity between product problem and recalls
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 settings and reports.
Sample Files: AI-Risk-Assistant
App Description
App Use Case: The AI-Risk-Assistant collects and analyzes vast amounts of data from diverse sources to pinpoint safety trends and device issues, enabling proactive risk mitigation in premarket and post market risk management activities (e.g., PMS - post market surveillance). Utilizing AI capabilities, and access to abundant public data such as Recalls Enforcement and MAUDE data (courtesy of FDA), the Risk Assistant offers powerful tools to see the bigger picture and make better informed decisions. The Risk-Assistant easily consolidates key problems and potential harms associated with specific product codes, brands, or multiple devices under the same regulation, and presents those hidden insights and data patterns in an easy-to-understand format. This aids the risk management professional in balancing risks against benefits, and adopting a quantitative, data-driven approach, free from biases.
App Functionality: The AI-Risk-Assistant is designed to process product risk information, which may include details such as device models, usage settings, product codes/registrations, and other pertinent data. A Settings file contains the specific MAUDE and Recalls database query parameters as well as the AI prompts to process the data and identify hidden patterns and insights. With this information, the retrieval augmented generation model correlates the MAUDE and Recalls data sets and maps this information in a table format for easy consumption in risk management processes, such as hazard analyses, FMEAs (Failure Mode Effects Analysis) and other tools. The correlation is influenced by product codes, problem codes, specific malfunctions, use errors, root causes and reasons for recall, among other factors found in the data set and specified in the Settings file.
Diagram outlining the processing steps of the Risk Assistant:
An Excel document is generated containing results detailing the top product problems, along with additional analytics for each product problem including correlated produce recalls. It also includes the correlation information and hidden patterns in the MAUDE and Recalls data.