Predicate Device Analysis
AI-powered substantial equivalence analysis with FDA expert-guided predicate selection. Comprehensive multi-source data search, business impact assessment, and intelligent ranking using FDA criteria to find the optimal predicate device for your 510(k) submission.
FDA expert-guided. Comprehensive analysis. Optimal selection.
6-Phase Predicate Selection Process
Comprehensive AI-powered analysis using FDA expert guidance to identify and rank optimal predicate devices.
Orchestrated Data Collection
Automatically gathers classification and regulatory assessment data. Auto-orchestrates assessment if needed, ensuring all prerequisite information is available for predicate analysis.
FDA Expert-Guided Analysis
AI performs FDA expert-guided predicate analysis, evaluating substantial equivalence using FDA criteria. Analyzes device characteristics, intended use, and technology against predicate candidates.
Multi-Source Data Search
Comprehensive search across 510(k) summaries, GUDID, and classification databases. Uses intelligent similarity matching (85% threshold) and recency filtering (8 years max) to find viable predicates.
Candidate Validation
Validates predicate candidates against device characteristics, ensuring compatibility. Filters out incompatible predicates and identifies exclusions with FDA-compliant reasoning.
FDA Criteria Ranking
Ranks candidates using FDA criteria, scoring across multiple dimensions including substantial equivalence strength, recency, similarity, and regulatory compliance.
Substantial Equivalence Analysis
Generates comprehensive substantial equivalence analysis with detailed comparisons, differences assessment, business impact evaluation (testing, cost, timeline, risk), and actionable recommendations.
Advanced Capabilities
Comprehensive AI-powered features for optimal predicate device selection.
psychologyAI Reasoning Engine
Uses intelligent AI reasoning (not rigid rules) to evaluate predicate devices for substantial equivalence. Adapts to device characteristics and FDA expectations.
searchMulti-Source Search
Comprehensive search across 510(k) summaries, GUDID, classification databases, and regulatory sources. Ensures no viable predicate is missed.
analyticsMulti-Dimensional Scoring
Scores viable predicates across multiple dimensions: substantial equivalence strength, similarity (85% threshold), recency (8 years max), and regulatory fit.
business_centerBusiness Impact Analysis
Evaluates business impact including required testing, estimated costs, timeline implications, and risk assessment for each predicate candidate.
ruleFDA-Compliant Exclusions
Intelligently determines predicate exclusions with FDA-compliant reasoning, explaining why certain predicates are not suitable for your device.
compareSubstantial Equivalence Comparison
Detailed comparison tables showing device characteristics, intended use, technology, and differences between your device and predicate candidates.
recommendActionable Recommendations
Provides clear, actionable recommendations for predicate selection, including rationale for top choices and guidance on next steps.
verifiedFDA Criteria Validation
All predicate analysis follows FDA criteria and guidelines, ensuring your substantial equivalence argument meets FDA reviewer expectations.
Why Choose Cruxi Predicate Analysis?
FDA expert-guided analysis with comprehensive business impact assessment.
auto_awesomeAI-Powered Intelligence
Advanced AI reasoning engine evaluates predicates using FDA expert knowledge, not just keyword matching. Understands context and regulatory nuances.
databaseComprehensive Database
Access to complete FDA 510(k) database with thousands of cleared devices. Search and compare against all available predicates.
insightsBusiness Impact Insights
Understand the business implications of each predicate choice—testing requirements, costs, timelines, and risk factors—before making your selection.
speedIntelligent Filtering
Smart similarity matching (85% threshold) and recency filtering (8 years) automatically narrow down to the most viable predicate candidates.
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