PI

Predicate Intelligence

Manufacturer-first regulatory intelligence for predicate strategy, evidence planning, portfolio monitoring, and submission readiness.

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💬 Ask AI

Predicate Intelligence Assistant

Ask about predicates, testing, manufacturers, or standards

Hi! Ask me anything about FDA 510(k) predicates, testing expectations, manufacturers, or regulatory standards. I query the knowledge graph directly.
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Manufacturer First

Move from raw graph retrieval to regulatory decision support.

Use the tabs to run focused workflows for predicate strategy, readiness planning, evidence benchmarking, portfolio reuse, and watch monitoring.

Predicate strategy shows why a candidate scored well and which overlap dimensions carried the score.
Readiness gaps flags missing tests, standards, guidance, and unsupported claim signals vs the cohort.
Evidence matrix converts the cohort into coverage tables you can share in internal reviews.
Portfolio + watch views surface manufacturer reuse patterns plus recalls, signals, and standards updates.
Predicate Strategy ranks candidate predicates by product code, regulation, intended use, anatomy, technological overlap, test overlap, and observed market history.
Readiness Gaps benchmarks the selected device or draft against a similarity cohort and flags missing tests, standards, guidance, and unsupported claim signals.
Competitive Watch blends public graph context with local recall, adverse-event, and recognized-standard fixtures so monitoring starts wired.

Predicate Strategy

Ranked predicates with transparent reason codes and supporting citations.

Select a device and click Predicate Strategy to score likely predicates.

Readiness Gaps

Missing tests, standards, guidance, and unsupported claim signals against the benchmark cohort.

Click Readiness Gaps to compare the target against similar clearances.

Evidence Matrix

Common tests, standards, guidance, and acceptance patterns for the nearby cohort.

Click Evidence Matrix to see coverage expectations at a glance.

Portfolio View

Portfolio reuse opportunities, recurring predicates, evidence reuse candidates, and reviewer patterns.

Click Portfolio View for the selected manufacturer.

Competitive Watch

Recalls, adverse events, and recognized standards wired into manufacturer context.

Click Competitive Watch to load watch items for the selected manufacturer (or global watch).

Trust Layer — Data Quality + Citations

Chunk coverage, validation issues, normalization links, and source snippets for the selected device.

Select a graph device to inspect extraction quality, citation coverage, and validation notes.

Assistant — Natural Language Q&A

Ask about predicates, testing expectations, manufacturers, or standards. (You can also use the 💬 Ask AI drawer.)