AI-Risk-Assistant - Revision history

Waghanna at 00:50, 21 April 2024

2024-04-21T00:50:10Z

← Older revision		Revision as of 00:50, 21 April 2024
Line 82:		Line 82:

	'''App Use Case:'''		'''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. 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.		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:'''		'''App Functionality:'''

Waghanna: /* App Description */

2024-04-15T21:58:05Z

App Description

← Older revision		Revision as of 21:58, 15 April 2024
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	==App Description==		==App Description==

	'''Use ~~case~~:'''		'''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. 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.		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. 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.

	'''~~Model description~~:'''		'''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.		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.

Waghanna at 19:21, 15 April 2024

2024-04-15T19:21:53Z

← Older revision		Revision as of 19:21, 15 April 2024
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	Reference file: [[Media: openFDA recall_search_fields.xlsx]]		Reference file: [[Media: openFDA recall_search_fields.xlsx]]

	{\| role="presentation" class="wikitable mw-collapsible mw-collapsed"		{\| role="presentation" style="min-width:250px;" class="wikitable mw-collapsible mw-collapsed code-sample"
	\| <strong>Settings.txt</strong>		\| <strong>Settings.txt</strong>
	\|-		\|-

Waghanna at 18:17, 13 April 2024

2024-04-13T18:17:04Z

@@ Line 1: / Line 1: @@
 ==App Files==
 <blockquote>
@@ Line 91: / Line 78: @@
 '''[[Sample Files: AI-Risk-Assistant]]'''

Waghanna at 21:15, 11 April 2024

2024-04-11T21:15:00Z

← Older revision		Revision as of 21:15, 11 April 2024
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	<blockquote>		<blockquote>
	Application executable: [[Media: AI-Risk-Assistant.zip]]		Application executable: [[Media: AI-Risk-Assistant.zip]]

	~~Reference file: [[Media: TPLCRiskAssessment-Schema.zip]]~~

	Reference file: [[Media: openFDA device_search_fields.xlsx]]		Reference file: [[Media: openFDA device_search_fields.xlsx]]

Waghanna at 04:02, 8 April 2024

2024-04-08T04:02:39Z

← Older revision		Revision as of 04:02, 8 April 2024
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	Diagram outlining the processing steps of the Risk Assistant:		Diagram outlining the processing steps of the Risk Assistant:

	[[Image: AI-Risk-Assistant-Process.jpg\|~~800px~~]]		[[Image: AI-Risk-Assistant-Process.jpg\|600px]]

Waghanna at 02:55, 8 April 2024

2024-04-08T02:55:46Z

← Older revision		Revision as of 02:55, 8 April 2024
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	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.		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.


	==App Files==		==App Files==

Waghanna at 02:52, 8 April 2024

2024-04-08T02:52:13Z

@@ Line 1: / Line 1: @@
 '''Use case:'''
-'''Model description:'''
+reason_for_recall:  // Recall example field
-Diagram outlining the processing steps of the Analysis Assistant:
+AI-WordsPerReport:   // Number of words in each intermediate report (recommended: 1500, range: 100-5000)
-[[Image: AI-Risk-Assistant-Process.jpg|800px]]
+AI-ModelTemperature:   // LLM Temperature index (recommended: 0.05, range: 0..1f)
-'''Reference files:'''
+AI-ModelMaxOutputTokens:   // LLM maximum output words (range: 1-2048)
-* [[Media: Sample-AI-Risk-Assistant.zip]]
+|}
-'''Additional information:'''
+'''[[Sample Files: AI-Risk-Assistant]]'''

Waghanna: Protected "AI-Risk-Assistant" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))

2024-04-07T10:39:54Z

Protected "AI-Risk-Assistant" ([Edit=Allow only administrators] (indefinite) [Move=Allow only administrators] (indefinite))

← Older revision	Revision as of 10:39, 7 April 2024
(No difference)

Waghanna: Created page with "'''Use case:''' '''Model description:''' Diagram outlining the processing steps of the Analysis Assistant: 800px '''Reference files:''' * Media: Sample-AI-Risk-Assistant.zip '''Additional information:'''"

2024-04-07T10:26:05Z

Created page with "'''Use case:''' '''Model description:''' Diagram outlining the processing steps of the Analysis Assistant: 800px '''Reference files:''' * Media: Sample-AI-Risk-Assistant.zip '''Additional information:'''"

New page

'''Use case:'''

'''Model description:'''

Diagram outlining the processing steps of the Analysis Assistant:

[[Image: AI-Risk-Assistant-Process.jpg|800px]]

'''Reference files:'''
* [[Media: Sample-AI-Risk-Assistant.zip]]

'''Additional information:'''