R-TF-015-006 Clinical investigation report

Research Title

Multi-Reader Multi-Case (MRMC) Study for Assessing the Performance of Legit.Health Plus on Fitzpatrick V-VI Phototype Skin Lesions

Product Identification

	Information
Device name	Legit.Health Plus (hereinafter, the device)
Model and type	NA
Version	1.1.0.0
Basic UDI-DI	8437025550LegitCADx6X
Certificate number (if available)	MDR 000000 (Pending)
EMDN code(s)	Z12040192 (General medicine diagnosis and monitoring instruments - Medical device software)
GMDN code	65975
EU MDR 2017/745	Class IIb
EU MDR Classification rule	Rule 11
Novel product (True/False)	TRUE
Novel related clinical procedure (True/False)	TRUE
SRN	ES-MF-000025345

Sponsor Identification and Contact

	Manufacturer data
Legal manufacturer name	AI Labs Group S.L.
Address	Street Gran Vía 1, BAT Tower, 48001, Bilbao, Bizkaia (Spain)
SRN	ES-MF-000025345
Person responsible for regulatory compliance	Alfonso Medela, Saray Ugidos
E-mail	office@legit.health
Phone	+34 638127476
Trademark	Legit.Health
Authorized Representative	Not applicable (manufacturer is based in EU)

Identification of the Clinical Investigation Plan (CIP)

	CIP
Title of the clinical investigation	Multi-Reader Multi-Case Study for Evaluating the Diagnostic Performance of Healthcare Professionals Assisted by Legit.Health Plus on Fitzpatrick Phototype V–VI Skin Presentations
Device under investigation	Legit.Health Plus
Protocol version	Version 1.0
Date	2026-04-14
Protocol code	LEGIT.HEALTH_MAN_2025
Sponsor	AI Labs Group S.L.
Coordinating Investigator	Dr. Antonio Martorell Calatayud
Principal Investigator(s)	Dr. Antonio Martorell Calatayud
Investigational site(s)	This study is conducted remotely through a centralized web-based platform.
Ethics Committee	This study does not require Ethics Committee approval because it is observational and non-interventional. All data used consists of fully anonymized images sourced from public dermatology atlases and databases, containing no information permitting patient identification. As such, the research meets the criteria for exemption from ethics committee review under applicable regulatory frameworks.

Study Design

This is a prospective, observational, multi-reader, multi-case (MRMC) self-controlled study evaluating whether the device improves the diagnostic accuracy of dermatologists on clinical images representing Fitzpatrick phototype V–VI skin. A minimum of 5 dermatologists were presented with 149 clinical cases sourced from public dermatological atlases.

Progressive information disclosure

For each clinical case, every reader completed a sequence of three assessment stages with progressively more device information:

1. Unassisted diagnosis (Stage 1): The reader viewed the clinical image and patient anamnesis, and provided their primary diagnosis without any device output.
2. Assisted diagnosis (Stage 2): The device's differential diagnosis (ICD-11 probability distribution) was additionally displayed. The reader provided their revised diagnosis.
3. Referral assessment (Stage 3): The device's malignancy probability, referral recommendation, and diagnostic entropy were additionally displayed. The reader decided whether to refer the patient.

The stages were completed sequentially for each case before the reader proceeded to the next case. The order of case presentation was independently randomised for each reader to prevent order effects. This sequential per-case design mirrors the intended clinical workflow and ensures that the unassisted diagnosis is recorded before the reader sees any device output.

Reference standard

The reference standard for diagnostic accuracy is the published atlas diagnosis — the diagnosis assigned to each clinical image by the originating public dermatological atlas. The ground truth diagnosis is encoded as an ICD-11 code for each case and was established prior to and independently of this study.