Response

We have updated R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan and R-TF-015-001 Clinical Evaluation Plan (CEP) to address the points raised. The PMCF Plan has been expanded with detailed methodological descriptions for all 11 activities (A.1 through D.2), a teledermatology clarification, and an equivalent-device evaluation; two new activities (D.1 and D.2) have been added to address the evidence-coverage gaps declared in the CER per MDCG 2020-6 § 6.5(e). The CEP has been updated for consistency with the 11-activity PMCF programme. Supporting Clinical Investigation Plans (R-TF-015-004) for the planned PMCF studies are maintained in the technical file.

The specific improvements made are as follows:

• Detailed Activity Descriptions: For each of the 11 PMCF activities (A.1 through D.2), we have provided a full and comprehensive description that includes:

  • Rationale: Clear justification for the activity, explicitly linked to the CER gaps (Triage, Severity Assessment, or Core Performance).
  • Methodology: Detailed study design (e.g., multireader multicase, prospective interventional, or retrospective observational).
  • Sample Size and Justification: Specific sample sizes (e.g., 30,000 images for A.1, 140 patients for A.2, 30 readers for C.1) with statistical or clinical feasibility rationales.
  • Acceptance Criteria: Measurable thresholds for success, such as AUC >= 0.8, diagnostic accuracy improvement of >= 10%, or Intraclass Correlation Coefficient (ICC) > 0.75 for reliability studies.
  • Timelines: Expected start and completion dates for each activity.

• Clarification of "Teledermatology": We have clarified in the PMCF rationale that "teledermatology" refers to a clinical workflow use-scenario (the remote capture and transmission of images) rather than a device feature. The PMCF activities evaluate the device's core performance within these specific real-world clinical contexts.

• Device Identification: We have explicitly confirmed throughout the plan that all activities evaluate the current version of the device, ensuring consistency across all technical records.

• Evaluation of Equivalent and Similar Devices: A new section has been added to the PMCF Plan providing an evaluation of clinical data from similar AI-based dermatology devices, as required by Annex XIV Part B 6.2(a).

• Consistency with the CEP: The R-TF-015-001 Clinical Evaluation Plan has been updated to correctly reflect the planned PMCF investigations, ensuring alignment between the scoping documents and the proactive data collection program.

• Section D: Evidence Coverage Gaps (new). A new section D has been added to the PMCF Plan addressing the two evidence coverage gaps declared in the CER per MDCG 2020-6 § 6.5(e). These activities ensure that the CER's acceptable gap declarations are supported by specific, linked PMCF activities:

  • Activity D.1: Prospective surveillance of autoimmune skin condition recognition in clinical deployment. Addresses CER Gap 4 (autoimmune diseases, 3% of dermatological presentations). Methodology: prospective, observational, real-world data collection from clinical sites. Diagnosis confirmation: dermatologist assessment with serological confirmation where clinically indicated. Conditions in scope: bullous pemphigoid, cutaneous lupus erythematosus, dermatomyositis, morphea, pemphigus foliaceus. Sample size: 50 confirmed autoimmune cases. Acceptance criteria: Top-3 accuracy for the confirmed autoimmune category >= 60%; safety criterion based on zero cases where the device output contributed to clinically significant diagnostic delay; surveillance trigger if at any annual interim review more than 20% of confirmed autoimmune cases have the correct category ranked below Top-5, initiating an unscheduled CER update. Timeline: continuous from CE marking; first interim analysis at 12 months or 15 cases; target completion at 50 cases or 36 months.

  • Activity D.2: Passive surveillance of genodermatoses in post-market deployment. Addresses CER Gap 5 (genodermatoses, 1% of presentations). Methodology: passive surveillance through PMS system. Active recruitment is explicitly not conducted, justified by the extreme rarity (approximately 1% of presentations) and the dependence of genodermatosis diagnosis on genetic testing rather than image-based assessment. No pre-specified sample size target. Acceptance criteria: zero confirmed genodermatosis cases where the device output contributed to patient harm; surveillance trigger if >3 cases in any 12-month period with all genodermatosis categories ranked below Top-5; coverage trigger at 30 cumulative cases initiating formal accuracy analysis. Timeline: continuous throughout device lifetime; annual review in PMCF Evaluation Report.

• Reference to Supporting Documents: The PMCF Plan cross-references the Clinical Investigation Plans (R-TF-015-004) for the planned PMCF studies maintained in the technical file.