cover-letter

• Study: Physician questionnaire evaluating the clinical performance of the equivalent legacy device in routine clinical practice (R-TF-015-012).
• Population: Healthcare professionals at institutions with ≥6 months of legacy device use (21 institutions).
• Collection Window: 23 March 2026 to 13 April 2026.
• Respondent data: 60 responses collected.
• Respondent dataset: Appendix C to R-TF-015-012 (60 responses collected; analysis set n = 56 after application of the protocol's Section 10.7 evidence-quality substantiation principle — see the PMS Study Report, "Data-quality exclusions")
• Signatories: Jordi Barrachina, PhD (Clinical Research Coordinator).

Dear Colleague,

On behalf of the clinical evaluation team, I would like to thank you for participating in the post-market observational study of our legacy dermatological assessment tool.

Your feedback is essential for our ongoing clinical evaluation under the Medical Device Regulation (MDR) and helps us demonstrate how the device performs in real-world clinical practice.

The physician questionnaire was open from 23 March 2026 to 13 April 2026. The archived respondent dataset is retained by the manufacturer within the QMS as Appendix C to R-TF-015-012, and is available for audit on request (60 responses collected; analysis set n = 56 after application of the protocol's Section 10.7 evidence-quality substantiation principle).

For any questions regarding the study or the use of the data, please contact the clinical research team.

Sincerely,

Jordi Barrachina, PhD Clinical Research Coordinator AI Labs Group