Medical Device & SaMD FDA 510(k) AI Privacy: Sanitize Design Files & Usability Data

import { PrivacyScrubberEngine } from '@privacyscrubber/sdk';

const engine = new PrivacyScrubberEngine({
  profile: 'General',
  detectSecrets: true
});

const submissionExcerpt = `FDA 510(k) PRE-MARKET SUBMISSION DRAFT:
Device Trade Name: CardioVision AI Diagnostic Suite (Class II SaMD).
Lead Clinical Investigator: Dr. Marcus Vance, Cedars-Sinai Medical Center.
Predicate Device: K210948 (HeartScan Analytics v3.2).
Human Factors Protocol HF-2025-04: 30 clinicians tested across 120 simulated telemetry events.
Study Participant: Maria Gonzalez (DOB: 1968-04-12, MRN: 918-204-88).
Clinical Endpoint: Sensitivity: 96.2%, Specificity: 93.4%, P-value < 0.001.`;

const { sanitizedText, tokenMap } = engine.sanitize(submissionExcerpt);
console.log('Sanitized Dossier for Regulatory AI Review:\n', sanitizedText);

// Restore original device trade name and investigator into executive summary
const rawAiSummary = 'The substantial equivalence evaluation for [ORG_1] demonstrates equivalent diagnostic efficacy to K210948.';
const finalSubmissionDoc = engine.restore(rawAiSummary, tokenMap);