📋 Post-Market AI Device Surveillance Simulator

Device Cleared and Deployed to the Market

Placeholder lead: clearance is a starting gate, not the finish line.

• 510(k) / De Novo: Clearance pathway (placeholder sub-caption)
• Rolling rollout: Sites at launch (placeholder sub-caption)
• Pre-market only: Baseline dataset (placeholder sub-caption)
• Day 0: Surveillance start (placeholder sub-caption)

Placeholder section heading

Placeholder body text, short filler describing market entry and surveillance obligations kicking in immediately.

Real-World Usage Data Begins Accumulating

Placeholder lead: every use generates a new data point to watch.

• 3 types: Data streams (placeholder sub-caption)
• Continuous: Performance logs (placeholder sub-caption)
• Voluntary reports: User feedback (placeholder sub-caption)
• Mandatory reports: Adverse events (placeholder sub-caption)

Placeholder section heading

Placeholder body text, short filler describing performance metrics, feedback, and event reports arriving.

Surveillance System Aggregates and Analyzes the Stream

Placeholder lead: raw reports become a running statistical picture.

• Continuous: Aggregation cadence (placeholder sub-caption)
• Pre-market rate: Baseline comparator (placeholder sub-caption)
• Rate + trend: Analysis method (placeholder sub-caption)
• Periodic + triggered: Review cadence (placeholder sub-caption)

Placeholder section heading

Placeholder body text, short filler describing continuous aggregation and trend analysis.

A Concerning Pattern Emerges in the Data

Placeholder lead: a threshold crossing turns monitoring into a signal.

• Rate / cluster: Signal type (placeholder sub-caption)
• Threshold crossing: Detection trigger (placeholder sub-caption)
• Subgroup-specific: Use-case scope (placeholder sub-caption)
• Severity triage: Next step (placeholder sub-caption)

Placeholder section heading

Placeholder body text, short filler describing signal emergence and triage.

Escalation Pathway Triggered by Severity

Placeholder lead: outcome scales with how serious the signal is.

• Labeling update: Minor outcome (placeholder sub-caption)
• Corrective action: Moderate outcome (placeholder sub-caption)
• Field safety notice: Severe outcome (placeholder sub-caption)
• Recall: Worst case (placeholder sub-caption)

Placeholder section heading

Placeholder body text, short filler describing the branching escalation ladder.

Placeholder highlight: escalation severity is proportional to real-world risk evidence.