{
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  "snapshotExportedAt": "2026-10-19T11:12:05.379339+00:00",
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    "de_novo": 37,
    "classification": 10,
    "510k": 1564,
    "pma": 836,
    "trial": 17,
    "grant": 5,
    "publication": 21
  },
  "curatedEntries": 10,
  "curatedAssertions": 21,
  "localizedAssertions": 20,
  "explicitAbstentions": 1,
  "sourceContextEntries": 652,
  "sourceContextAssertions": 712,
  "automaticallyAcceptedMappings": 0,
  "independentlyAdjudicatedMappings": 0,
  "precision": null,
  "confidenceInterval": null,
  "reason": "No independent ground truth adjudication. Curator assertions and regression checks are not a precision estimate.",
  "jobStates": {
    "complete": 52,
    "failed": 3
  },
  "thalamusTopography": {
    "families": "3",
    "regulatory": "3",
    "grants": "Unmapped"
  },
  "localVerification": {
    "recordedDate": "2026-10-19",
    "domainAndDataChecksPassed": 29,
    "ingestionChecksPassed": 24,
    "browserChecksPassed": 16,
    "typecheck": "passed",
    "productionBuild": "passed",
    "scope": "Recorded local checks on the atlas snapshot. Mobile coverage is Chrome touch emulation, not physical iPhone/Safari. No independent scientific accuracy estimate."
  },
  "releaseDisposition": "Public research preview. Provisional anatomical contexts and incomplete historical coverage are not clinical validation.",
  "interactivePreview": {
    "path": "/atlas",
    "delivery": "Self-contained static snapshot; no live ingestion or private workspace."
  },
  "explanationExpansion": {
    "recordedDate": "2026-10-22",
    "explainedEntries": 91,
    "directlyAssociatedStructuresAndRegions": 44,
    "newExplainedEntries": 75,
    "newPmaStatementsAndDecisionDatesMatchedToOriginals": 73,
    "newPdfIndicationsChecked": 2,
    "domainAndExportChecksPassed": 35,
    "ingestionChecksPassed": 26,
    "browserEntriesCheckedPerViewport": 75,
    "scope": "Record-specific editorial explanations checked against original FDA sources. Historical evidence; current labeling, recall completeness and independent expert mapping precision remain unverified."
  },
  "dossierMilestone": {
    "recordedDate": "2026-10-22",
    "explainedEntriesWithDossiers": 91,
    "marketingApplicationsChecked": 89,
    "pmaApplications": 85,
    "pmaDecisionRecords": 6505,
    "originalLabelDocumentsLinked": 105,
    "entriesWithOriginalLabels": 76,
    "locatedLabelSectionHeadings": 61,
    "readableDocumentsWithSectionLocators": 19,
    "recallQueryRecords": 351,
    "acceptedDirectApplicationRecallRecords": 349,
    "malformedRecallReferencesHeldForReview": 2,
    "noticeIndexPages": 6,
    "uniqueNoticeUrlsScreened": 410,
    "domainChecksPassed": 47,
    "ingestionChecksPassed": 36,
    "portfolioChecksPassed": 95,
    "browserDossiersCheckedPerViewport": 91,
    "viewportModes": [
      "desktop Chrome",
      "mobile Chrome viewport/touch emulation"
    ],
    "currentLabelContentAndRevisionReview": "91 individual source assessments; 3 product-specific gaps; historical/model-limited sources retained",
    "affectedModelLotApplicabilityReview": "349 source-field audits; patient/unit applicability not determined",
    "completeManufacturerAndPre2023NoticeReview": "pending",
    "scope": "Source inventory and original decision identity/date reconciliation. Label discovery/section headings do not certify current labeling; direct application recall links do not establish model/lot applicability. No independent clinical or anatomical precision claim."
  },
  "labelSafetyReview": {
    "recordedDate": "2026-10-22",
    "entriesAssessed": 91,
    "adequateProductSpecificLabelStillMissing": 3,
    "publishedIfuReviews": 8,
    "publicManufacturerSafetyReviews": 30,
    "historicalLabelReviews": 29,
    "modelLimitedSourceReviews": 15,
    "otherHistoricalSourceReviews": 3,
    "modelSourceReviews": 1,
    "investigationalEntries": 2,
    "recallSourceFieldAudits": 349,
    "recallSourceRecordsWithFlags": 24,
    "noticeScopeDecisions": 15,
    "uniqueNoticesReviewed": 14,
    "unitApplicability": "not determined",
    "completeLatestIfuCertification": false,
    "method": "Agent-assisted editorial primary-source text/excerpt assessment; exact source/revision/model scope and open limits are visible. Field audits are not independent clinical signoff.",
    "localVerification": {
      "atlasTests": 47,
      "ingestionTests": 36,
      "portfolioTests": 95,
      "browserDossiersPerViewport": 91,
      "axeViolations": 0,
      "browserErrors": 0,
      "p95SelectionToDossierMs": {
        "desktop": 228,
        "mobile": 117
      },
      "scope": "Local Chrome; mobile touch/viewport emulation. Not independent clinical validation."
    },
    "documentTraceFollowup": {
      "recordedDate": "2026-10-22",
      "completeIfusRecovered": 0,
      "fullLabelGapsRemaining": 3,
      "historicalManufacturerExcerptLead": "Braun-Cutter / Avanta CMC identity crosswalk and product insert indexed in FDA K931588 archive; full revision and PDF unavailable",
      "knownRestrictionsAdded": [
        "Hudi K260007 condom incompatibility",
        "Advanced Glenoid cemented socket versus humeral fixation permissions"
      ],
      "outreach": "Document requests retained as drafts; not sent",
      "warningClarity": "Review meanings, compared models, revision limits and first entry-specific limitation visible; same context preserved in briefs."
    }
  }
}