The goal of this observational study is to learn if an artificial intelligence (AI) tool helps primary care practitioners better identify skin conditions. The study focuses on adults with suspected skin pathologies, including tumor, inflammatory, and infectious diseases.

The main questions it aims to answer are:

• Does using the AI tool help doctors make more accurate diagnoses for multiple skin conditions?
• Does the tool help doctors better decide which patients need a referral to a dermatologist and which can be managed in primary care?
• Are doctors satisfied with how well the tool works and how easy it is to use in their daily work?
• Can the tool help doctors more accurately differentiate between benign lesions and skin cancer?

Participants will:

• Visit their primary care doctor for a regular skin checkup.
• Have photos taken of their skin condition using a smartphone or a dermatoscope.
• Provide informed consent for their photos and basic health information (such as age and sex) to be analyzed by the AI tool.
• Receive standard care from their doctor, with the tool providing a second opinion to assist in the clinical decision-making process.

This prospective, observational study evaluates the clinical utility of an artificial intelligence (AI)-based computational software device designed to support primary care practitioners (PCPs) and dermatologists in managing skin pathologies. The research explores whether the device can enhance diagnostic accuracy and optimize the referral process from primary care to specialized dermatology services.

Study Methodology and Design

The investigation is designed as an analytical study of a clinical case series. Key technical aspects include:

• Investigational Tool: A software-only medical device using computer vision algorithms to analyze images of the epidermis and dermis to provide clinical data for assessment.
• Participant Roles: 15 HCPs (including PCPs and dermatologists) evaluated with a cohort of over 100 patients.
• Procedural Workflow: PCPs captured skin images using smartphones or mobile dermatoscopes, uploaded them to the platform, and provided a diagnosis guided by the AI results.
• Evaluation Baseline: HCPs acted as their own controls, allowing for a comparison of diagnostic performance with and without the AI tool.

Quality Assurance and Registry Procedures

To ensure the integrity of the data collected within this organized system, several quality control measures were implemented:

• Data Validation and Checks: The database utilized consistency rules and logical ranges to control errors during tabulation. Computerized validation filters automatically identified missing values or inconsistencies based on predefined rules.
• Source Data Verification (SDV): A designated independent clinical monitor performed verification of anonymized source documents (e.g., image files and clinical records) against Case Report Forms (CRFs) to ensure accuracy and completeness.
• Monitoring Plan: The research team held quarterly meetings to address data collection issues, while the monitor conducted remote and, if necessary, on-site visits to ensure compliance with the Clinical Investigation Plan (CIP) and ISO 14155 standards.
• Missing Data Management: Manual editing and exploratory statistical techniques were used to detect and resolve logical errors or inconsistent values before the database was considered closed.

Sample Size and Statistical Principles The study was powered to detect a 10% improvement in diagnostic accuracy.

• Assessment Power: A sample size of 100 patients was determined to provide a 95% confidence level with an 80% power and a margin of error between 9% and 10%.
• Analytical Techniques: Central tendency and variability statistics (mean, SD) were used for quantitative variables, while qualitative variables were analyzed through frequency distributions.
• In addition to parametric tests, the McNemar test was used to analyze the specific impact of AI on HCP diagnostic choices. Statistical significance was set at alpha = 0.05.

For qualitative data, Fisher's exact or Chi-square tests were employed. Statistical significance was set at alpha = 0.05.

Safety and Ethical Standards The study complied with Regulation (EU) 2017/745 (MDR) and ISO 14155:2021. Data protection followed GDPR and Spanish Organic Law 3/2018, utilizing encrypted patient information and alphanumeric identification codes to maintain participant anonymity. All clinical data stored on the device is permanently deleted upon study conclusion.

Inclusion Criteria:

• Tumor pathology:
• Benign:
• Histiocytoma
• Seborrheic keratosis
• Angiomas
• Precancerous:
• Actinic keratosis
• Suspected malignancy:
• Basal cell carcinoma
• Squamous cell carcinoma
• Pigmented lesions:
• Melanocytic nevus
• Malignant melanoma
• Inflammatory pathology:
• Psoriasis
• Atopic dermatitis
• Urticaria
• Hidradenitis suppurativa
• Lichen planus
• Infectious pathology:
• Viral warts
• Molluscs
• Herpes simplex
• Patients aged 18 years or older.
• Patients who have signed the informed consent for the study.

Exclusion Criteria:

• Patients under 18 years of age.
• Pregnant patients.
• Patients who, in the opinion of the researcher, will not comply with the study procedures.

The study population is drawn from adult patients presenting with dermatological concerns at two primary care centers in the Madrid region: Centro de Salud de Majadahonda and Centro de Salud de Pozuelo. These participants are residents within the catchment areas of these clinics, with Hospital Universitario Puerta de Hierro Majadahonda serving as their reference hospital for specialized dermatology care.

The source population consists of individuals in a real-world clinical setting undergoing preliminary assessment by primary care practitioners (PCPs) for potential referral to specialized dermatology services. This diverse cohort is intended to represent a typical population affected by various skin pathologies, specifically including tumoral (benign and malignant), inflammatory, and infectious conditions.

Participants are identified and recruited during routine medical visits whenever a skin-related pathology is suspected.