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  • Welcome to your QMS
  • Quality Manual
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  • Legit.Health Plus Version 1.1.0.0
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    • Technical Review
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      • Round 1
        • Item 0: Background & Action Plan
        • Item 1: CER Update Frequency
        • Item 2: Device Description & Claims
        • Item 3: Clinical Data
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
        • Item 7: Risk
        • completed-tasks
          • task-3b10-legacy-pms-document-hierarchy-refactor
          • task-3b11-sme-coverage-subspecialty-documentation
          • task-3b12-phase-1-exploratory-per-bucket-c-feature
          • task-3b13-man-2025-cep-cip-completeness
          • task-3b14-ifu-integration-requirements-verification
          • task-3b4-mrmc-dark-phototypes
          • task-3b6-surrogate-endpoint-literature-review
            • Appraisal log — CRIT1–7 rolling table
            • Do we need this task?
            • Integration map — propagation of the surrogate-endpoint validity review
            • references
              • diagnostic-accuracy
                • Conic 2018 — Impact of melanoma surgical timing on survival (NCDB)
                • Daneshjou 2022 — Disparities in dermatology AI performance on a diverse clinical image set (DDI) [BALANCING]
                • Dick 2019 — Accuracy of computer-aided diagnosis of melanoma: a meta-analysis
                • Esteva 2017 — Dermatologist-level classification of skin cancer with deep neural networks
                • Freeman 2020 — Algorithm-based smartphone apps for skin cancer risk: BMJ systematic review [BALANCING]
                • Gershenwald 2017 — AJCC 8th edition: melanoma staging and survival gradient
                • Haenssle 2018 — Man against machine: CNN vs 58 dermatologists for melanoma recognition
                • Haenssle 2020 — Man against machine reloaded: market-approved CNN (Moleanalyzer Pro) vs 96 dermatologists
                • Han 2018 — Clinical-image classification for benign and malignant tumours (cross-ethnicity) [BALANCING]
                • Liu 2020 — A deep learning system for differential diagnosis of skin diseases
                • Salinas 2024 — Systematic review and meta-analysis of AI vs. clinicians for skin cancer diagnosis
                • Tschandl 2020 — Human–computer collaboration for skin cancer recognition
                • Winkler 2023 — Dermatologists cooperating with a CNN: prospective clinical study
              • referral-optimisation
              • severity-assessment
            • Research prompts — external deep-research tools
            • Surrogate-Endpoint Validity in Dermatology AI — Structured Literature Review
          • task-3b7-icd-per-epidemiological-group-vv
          • task-3b8-safety-confirmation-column-definition
          • task-3b9-legacy-pms-conclusions-into-plus-pms-plan
        • Coverage matrix
        • resources
        • Task 3b-5: Autoimmune and Genodermatoses Triangulated-Evidence Package
      • Evidence rank & phases
      • Pre-submission review of R-TF-015-001 CEP and R-TF-015-003 CER
  • Pricing
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  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • completed-tasks
  • task-3b6-surrogate-endpoint-literature-review
  • references
  • diagnostic-accuracy
  • Dick 2019 — Accuracy of computer-aided diagnosis of melanoma: a meta-analysis

Dick 2019 — Accuracy of computer-aided diagnosis of melanoma: a meta-analysis

Citation​

Dick V, Sinz C, Mittlböck M, Kittler H, Tschandl P. Accuracy of computer-aided diagnosis of melanoma: a meta-analysis. JAMA Dermatol. 2019 Nov 1;155(11):1291–1299. DOI: 10.1001/jamadermatol.2019.1375. PMID 31215969.

Study design and population​

Systematic review and bivariate random-effects meta-analysis of 132 computer-aided melanoma diagnosis studies (January 2002 – December 2018); 70 studies quantitatively pooled.

Reported metrics​

  • Pooled CAD melanoma sensitivity 0.74 (95 % CI 0.66–0.80)
  • Pooled CAD melanoma specificity 0.84 (95 % CI 0.79–0.88)
  • Independent test sets: sensitivity 0.51 (95 % CI 0.34–0.69) vs. non-independent 0.82 (95 % CI 0.77–0.86), p < 0.001
  • CAD performance approximately equivalent to dermatologist sensitivity; ~10 pp lower specificity (non-significant)

Surrogate-to-outcome linkage​

Highest-weight aggregate evidence that AI-derived diagnostic accuracy (sensitivity/specificity) is the accepted endpoint class for melanoma recognition in dermatology AI. The independent-test-set drop quantifies the external-validity gap that directly motivates PMCF performance monitoring under the EU MDR.

CRIT1–7 appraisal​

CriterionScoreJustification
CRIT1 Relevance3Direct — CAD melanoma diagnostic accuracy.
CRIT2 Methodology3Systematic review with bivariate random-effects meta-analysis; independent-vs-non-independent test-set stratification.
CRIT3 Reporting3Pooled estimates with 95 % CIs; spectrum-bias effect quantified.
CRIT4 Applicability2Aggregates predominantly curated-dataset studies; generalisability to primary-care populations limited.
CRIT5 Evidence weight3Meta-analysis — highest tier.
CRIT6 Risk of bias2High heterogeneity across primary studies; publication bias likely; limited phototype diversity in included studies.
CRIT7 Contribution3Core aggregate anchor for the accepted-surrogate claim; quantifies the independent-test-set gap as a declared PMCF target.

Aggregate: very strong.

Limitations and notes​

Heterogeneous primary studies; many from computer-science literature rather than clinical dermatology; publication bias; homogeneous phototype coverage.

Strength as anchor​

Very strong — the highest-tier aggregate evidence in the domain. Used as the regulator-facing weight for the accepted-surrogate claim and the motivating citation for the phototype-bias + PMCF-performance-monitoring narrative.

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Daneshjou 2022 — Disparities in dermatology AI performance on a diverse clinical image set (DDI) [BALANCING]
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Esteva 2017 — Dermatologist-level classification of skin cancer with deep neural networks
  • Citation
  • Study design and population
  • Reported metrics
  • Surrogate-to-outcome linkage
  • CRIT1–7 appraisal
  • Limitations and notes
  • Strength as anchor
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