Response

Fix

We have implemented a comprehensive update across the clinical documentation to address the deficiencies identified by the Notified Body regarding the PMCF Plan.

The following documents have been revised:

• R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan: Expanded with detailed methodological descriptions for all 9 activities, teledermatology clarification, and equivalent device evaluation.
• R-TF-015-001 Clinical Evaluation Plan (CEP): Updated to ensure consistency with the 9-activity PMCF program, removing previous statements indicating no new studies were planned.

Furthermore, we have established the documentation structure for the supporting Clinical Investigation Plans (CIP, R-TF-015-004) for all planned PMCF studies within the technical documentation.

Response to BSI

We have updated the R-TF-007-002 Post-Market Clinical Follow-up (PMCF) Plan to address the points raised by the reviewer. Specifically, the following improvements have been made:

• Detailed Activity Descriptions: For each of the 9 PMCF activities (A.1 through C.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 $\ge$ 0.8, diagnostic accuracy improvement of $\ge$ 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 Legit.Health Plus (version 1.1.0.0) 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.

• Reference to Supporting Documents: The PMCF Plan now references the specific locations of the supporting Clinical Investigation Plans (R-TF-015-004) currently being drafted for these activities. These plans are organized within the technical documentation under:

  • Investigation/VH_triaje_2025 (Activity A.1)
  • Investigation/Sant_Pau_2024 (Activity A.2)
  • Investigation/VH_clinical_2025 (Activity A.3)
  • Investigation/AFF_2026 (Activity B.1)
  • Investigation/ALADIN 2026 (Activity B.2)
  • Investigation/aEASI_HVN_2026 (Activity B.3)
  • Investigation/AVASI_2026 (Activity B.4)
  • Investigation/ICD_DXP_2026 (Activity C.1)
  • Legit.Health-US-version-1-1-0-0 (Activity C.2)