R-TF-015-004 Clinical investigation plan

Scope

This Clinical Investigation Plan (CIP) sets out the rationale, objectives, design, methodology, conduct, implementation, record-keeping, and method of analysis for this clinical investigation.

CIP Identification

	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	2026-01-21
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.

Table of contents

• Scope
• CIP Identification
• Nature and positioning of the evidence
• Compliance Statement
• Abbreviations and definitions
• CIP or protocol specifications
  • Principal Investigator
  • Coordinating investigator
  • Collaborating Investigator(s)
  • Investigational sites
  • Funding
• Product Identification and Description
  • Device version under investigation and bridging to the CE-marked release
• Justification of the design
  • Background and rationale
  • Sourcing and curation of the image set
  • Risks and benefits of the product in investigation and clinical research
• Hypothesis
• Objectives
  • Primary objective
  • Secondary objectives
• Summary of the study
• Design and methods
  • Type of clinical research
  • Reference standard (ground truth)
  • Population
  • Sample size
    • Power calculation
  • Dermatological conditions and case distribution
  • Duration
  • Acceptance criteria
    • Justification of acceptance thresholds
  • Inclusion criteria
  • Exclusion criteria
  • Variables
    • Main variable
    • Secondary variables
  • Condition of interest
  • Limitations of clinical research
• Ethical considerations
  • Data confidentiality
  • Bias minimization measures
  • Calendar
  • Monitoring plan
  • Completion of the investigation
  • Statistical analysis
    • Pre-specified analyses
    • Exploratory and hypothesis-generating analyses
    • Handling of incomplete reader data
    • Software
  • Data management
    • Data collection
    • Access control and traceability
    • Data anonymity
    • Data export and analysis
    • Data security
• CIP Modification
• CIP Deviations
• Start, follow-up and end reports
• Statements of compliance
• Informed Consent process
  • For patients / image subjects
  • For healthcare professionals
• Adverse events, adverse product reactions and product deficiencies
  • Adverse Events (AE) and Adverse Events to the Product (AEP)
  • Product deficiencies
  • Serious Adverse Events, serious adverse events to the product and serious and unexpected adverse events to the product
  • Foreseeable adverse events and adverse events to the product
  • Data Monitoring Committee (DMC)
• Suspension or early termination of clinical research

Nature and positioning of the evidence

This is a simulated-use multi-reader multi-case (MRMC) investigation performed entirely on retrospective, fully anonymised dermatological images sourced from public dermatology atlases. No patients are recruited, no patient-identifiable data is processed, and no therapeutic or diagnostic intervention is performed on any patient as a consequence of the investigation. Healthcare professionals acting as readers participate in their professional capacity as expert evaluators of device performance; they are not enrolled as research subjects within the meaning of biomedical-research law.

Under MDCG 2020-6 Appendix III, this kind of investigation constitutes Rank 11 evidence (simulated-use reader study on retrospective images); it is not clinical data on real patients within the meaning of MDR Article 2(48).

Per MDCG 2020-1, this investigation contributes to Pillar 3 Clinical Performance at Rank 11 — it measures the clinician's diagnostic decision-making when using the device's Top-5 prioritised differential view on Fitzpatrick V and VI image presentations, which is the Pillar 3 claim for a decision-support device. Rank 11 (simulated-use) reflects that the measurement is performed on curated images rather than in live patient consultations, and positions this evidence below the Rank 2–4 prospective real-patient studies that carry the primary Pillar 3 weight. Real-world Pillar 3 Clinical Performance evidence on Fitzpatrick V and VI patients in routine care is addressed through Post-Market Clinical Follow-up at Clinical Evaluation Report level (R-TF-015-003).

MDCG 2020-1 Pillar 2 (Technical / Analytical Performance — the algorithm's classification accuracy across the 346 ICD-11 categories at API level) is evidenced independently of this investigation by the manufacturer's technical-validation record and by the four published peer-reviewed severity-validation studies. MDCG 2020-1 Pillar 1 (Valid Clinical Association — literature anchoring accurate/faster dermatology diagnosis to patient benefit) is evidenced in R-TF-015-011, which anchors the surrogate endpoints used in this investigation (top-1 diagnostic accuracy and appropriate specialist-referral decision) to downstream patient outcomes (earlier correct therapy initiation, reduced progression of malignant presentations, reduction in inappropriate referrals). The three-pillar causal chain — VCA literature (R-TF-015-011) → Pillar 2 API-level analytical performance across the 346 ICD-11 categories → Pillar 3 clinician + device performance on the device's Top-5 prioritised differential view → literature-anchored patient benefit — closes independently of this investigation; this investigation extends the Pillar 3 segment of that chain to Fitzpatrick V and VI presentations.

Extrapolation to real-world consulting populations, patient-outcome claims, time-to-correct-therapy claims, disease-burden claims or healthcare-economics claims is outside the scope of this investigation and is handled — with the appropriate real-world evidence — in the Clinical Evaluation Report.

Compliance Statement

The clinical investigation will be conducted according to the Clinical Investigation Plan (CIP) and other applicable guidances and regulations. This includes compliance with:

• The ethical principles originating from the World Medical Association's Declaration of Helsinki
• Harmonized standard UNE-EN ISO 14155:2020
• Regulation (EU) 2017/745 on medical devices (MDR), including the applicable General Safety and Performance Requirements (GSPR) as outlined in Annex I, and the requirements of Annex XV (Chapter I and Chapter II, Section 3)
• Harmonized standard UNE-EN ISO 13485:2016
• MDCG 2024-3 for its structural and content expectations, MDCG 2021-8 concerning application requirements, and MDCG 2020-10/1 Rev 1 for safety reporting timelines and definitions
• Regulation (EU) 2016/679 (GDPR)
• Spanish Organic Law 3/2018 on the Protection of Personal Data and guarantee of digital rights.

All data processing within the device is carried out in accordance with the highest standards of data protection and privacy. Patient information is managed in an encrypted manner to ensure confidentiality and security.

The research team assumes the role of Data Controller, responsible for the collection and management of study data. Legit.Health acts as the Data Processor and is not involved in the processing of patient data.

The storage and transfer of data comply with European data protection regulations. At the conclusion of the study, all information stored in the device will be permanently and securely deleted.

The device employs robust technical and organizational security measures to safeguard personal data against unauthorized access, alteration, loss, or processing.

Abbreviations and definitions

• AE: Adverse Event
• AEMPS: Spanish Agency of Medicines and Medical Devices
• AEP: Adverse Reaction to Product
• AUC: Area Under the ROC Curve
• CAD: Computer-Aided Diagnosis
• CMD: Data Monitoring Committee
• CIP: Clinical Investigation Plan
• CUS: Clinical Utility Questionnaire
• DLQI: Dermatology Quality of Life Index
• GCP: Standards of Good Clinical Practice
• ICH: International Conference of Harmonization
• IFU: Instructions For Use
• IRB: Institutional Review Board
• N/A: Not Applicable
• NCA: National Competent Authority
• PI: Principal Investigator
• PPV: Positive Predictive Value
• NPV: Negative Predictive Value
• SAE: Serious Adverse Events
• SAEP: Serious Adverse Event to Product
• SUAEP: Serious and Unexpected Adverse Event to the Product
• SUS: System Usability Scale

CIP or protocol specifications

Principal Investigator

• Dr. Antonio Martorell Calatayud

Coordinating investigator

• Dr. Antonio Martorell Calatayud

Collaborating Investigator(s)

• Medical staff — participating healthcare professionals are identified in the Clinical Investigation Report by anonymised reader codes (R-01, R-02, …). The code-to-identity master list, together with reader CVs, certification evidence and signed participation agreements, is maintained by the Principal Investigator under restricted access and is available for audit on request.
• Manufacturer
  • Mr. Taig Mac Carthy (Regulatory and Quality, manufacturer)
  • Mr. Alfonso Medela (Chief Scientific Officer, manufacturer)

Investigational sites

This investigation was conducted remotely through a centralised web-based platform operated by the manufacturer. Healthcare professionals acting as readers accessed the platform using individual user credentials (username and password); all assessments were recorded on the platform and access logs are maintained to ensure full traceability of reader interactions.

Funding

This research is carried out without any funding or sponsorship.

Product Identification and Description

	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

Throughout this document, references to "the device" refer to the investigational product identified above.

Device version under investigation and bridging to the CE-marked release

The investigation was conducted using device version v1.1.0.0, which is the only version placed on the market and the version to which the present technical documentation applies. No intermediate development build was used during the conduct of the investigation, and no changes to the algorithm, model checkpoint, user interface, indications or claims occurred between the version evaluated in this investigation and the version submitted for CE marking. The bridging between the investigation-version and the CE-marked release is therefore an identity bridge; no clinical-relevance assessment of inter-version differences is required. The device-version statement has been reviewed and signed off by the PRRC.

Justification of the design

Background and rationale

Dermatological conditions represent a significant portion of primary care consultations, constituting approximately 5% of all visits. Discrepancies between diagnoses made by general practitioners and dermatologists remain substantial, with concordance rates documented in the State-of-the-Art record R-TF-015-011 between 57% and 65.52%. The device has already been evaluated for HCP-aided diagnostic accuracy in three completed MRMC investigations (SAN_2024, BI_2024, PH_2024) and its case-level technical performance is documented in the Clinical Evaluation Report.

The image sets used by the three source MRMC investigations were drawn from public dermatology atlases and predominantly represented Fitzpatrick phototypes I–IV; Fitzpatrick phototypes V and VI were under-represented in those image sets. This investigation evaluates, under simulated-use conditions on a curated image set representative of Fitzpatrick V–VI presentations of the same dermatological conditions, whether the device changes HCP top-1 diagnostic accuracy relative to unaided reading of the same images.

Sourcing and curation of the image set

The investigation uses 149 anonymised images representative of Fitzpatrick phototype V and VI presentations. The clinical images used for the MAN_2025 study are sourced from public dermatological atlases under permissive licenses. We specifically curated a set of 149 clinical cases representing Fitzpatrick phototypes V and VI to ensure adequate representation of dark skin tones.

Each clinical case was subjected to a per-image quality-control review to verify:

• Accurate Fitzpatrick phototype representation (V or VI).
• Clear lesion morphology.
• Clinical-grade image quality and lighting.

The source provenance is documented within the manufacturer's case repository, which maps each case ID to its source atlas and original identifier. The provenance mapping is held by the manufacturer within the QMS and is available for audit on request. Because the image set is derived from retrospective, fully anonymised public-atlas images, this investigation constitutes simulated-use evidence under MDCG 2020-6 Appendix III Rank 11 and is not a substitute for real-world Fitzpatrick V–VI clinical data collected in a consulting population; the latter is addressed through Post-Market Clinical Follow-up at Clinical Evaluation Report level.

Risks and benefits of the product in investigation and clinical research

In this investigation there is no patient recruitment or active patient involvement. The images are fully anonymised and sourced from public dermatology atlases; they are not derived from identifiable patients. Participating healthcare professionals sign a participation agreement with the manufacturer regulating their involvement.

Hypothesis

• Null hypothesis (H₀): the use of the device does not change the pooled top-1 diagnostic accuracy of healthcare professionals on the curated Fitzpatrick V–VI image set — i.e., the paired difference between Stage 1 (unassisted) and Stage 2 (device-assisted) pooled top-1 accuracy is zero.
• Alternative hypothesis (H₁): the use of the device increases the pooled top-1 diagnostic accuracy of healthcare professionals on the curated image set by at least 10 percentage points.

The +10 percentage-point pre-specified effect size reflects the methodology documented in R-TF-015-011 §"Methodology for Establishing Acceptance Criteria", which sets the device's acceptance target approximately ten percentage points above the SotA-averaged AI-aided improvement baseline (overall HCP +6.36 %; primary-care +9.30 %; dermatologist +5.30 %). Setting the criterion above the SotA AI-aided baseline is the mechanism by which the investigation tests the "substantial clinical benefit" positioning required under MDCG 2020-1.

Objectives

Primary objective

To validate that the information provided by the device increases the top-1 diagnostic accuracy of healthcare professionals (HCPs) in the diagnosis of multiple dermatological conditions presented on Fitzpatrick phototype V–VI skin on the curated image set.

Top-1 diagnostic accuracy is used as the primary surrogate endpoint on the basis of the Pillar 1 Valid Clinical Association literature documented in R-TF-015-011, which links improved HCP top-1 accuracy on image-based dermatological assessment to downstream patient outcomes — earlier correct therapy initiation, reduced inappropriate-referral burden and, for malignant presentations, reduced time to specialist assessment. Patient-outcome endpoints themselves are outside the scope of this simulated-use investigation and are addressed through Post-Market Clinical Follow-up at Clinical Evaluation Report level.

Secondary objectives

• To characterise, as an exploratory descriptive, the proportion of cases for which the HCP, with the device's output available, considers that specialist referral is appropriate.
• To report, as an exploratory descriptive, the device's case-level malignancy-detection performance (ROC AUC) on the curated image set against the atlas-labelled ground truth.

No confirmatory malignancy-specific diagnostic-accuracy claim or malignancy-referral-sensitivity claim is made on the basis of this investigation: the 10 malignant cases in the curated image set (7 melanoma and 3 basal cell carcinoma) are sufficient to report a descriptive Stage 3 referral rate and a device-level ROC AUC, but the resulting confidence intervals are too wide to support confirmatory malignancy-focused conclusions. Confirmatory malignancy performance is addressed by the dedicated NMSC clinical investigation cited in the Clinical Evaluation Report and by the Post-Market Clinical Follow-up Plan.

Summary of the study

This is a prospective, observational, multi-reader, multi-case (MRMC) self-controlled investigation designed to assess whether the use of the device by healthcare professionals increases the top-1 diagnostic accuracy in the diagnosis of multiple dermatological conditions on a curated image set representative of Fitzpatrick phototype V–VI presentations. Healthcare professionals representative of the device's declared intended user groups — dermatologists, primary care physicians, and nurses with clinical responsibility for skin assessment — are presented with 149 images of different skin conditions on the curated image set. Data collection captures diagnostic accuracy for different dermatological pathologies as scored against the reference-standard diagnosis established for each image. The investigation is conducted in accordance with the applicable ethical principles for retrospective studies of anonymised material; because no patients are recruited or contacted, patient-level informed consent is not applicable.

Design and methods

Type of clinical research

This is a prospective, observational, multi-reader, multi-case (MRMC) self-controlled investigation to evaluate whether the use of the device by healthcare professionals helps to increase the accuracy in the diagnosis of different skin conditions presented on Fitzpatrick phototype V–VI skin. The investigation uses a progressive information-disclosure design: for each clinical case, the reader completes a sequence of three assessment stages that reveal progressively more device output. This within-case, within-reader comparison isolates the device's incremental contribution to diagnostic accuracy.

The three stages per case are:

1. Stage 1 (Unassisted diagnosis): the reader views the clinical image and patient anamnesis and provides their primary diagnosis without any device output.
2. Stage 2 (Assisted diagnosis): the device's differential diagnosis (top-5 ICD-11 probability distribution) is additionally displayed. The reader provides their revised diagnosis as a single top-1 selection.
3. Stage 3 (Referral assessment): the device's malignancy probability, referral recommendation and diagnostic entropy are additionally displayed. The reader decides whether to refer the case to a specialist.

The three stages are completed sequentially for each case before the reader proceeds to the next case. The order of case presentation is independently randomised for each reader to prevent order effects. The self-controlled comparison between Stage 1 (unassisted) and Stage 2 (assisted) for the same reader on the same case constitutes the primary paired observation.

This sequential per-case design mirrors the intended clinical workflow, in which a healthcare professional first forms an initial diagnostic impression and then consults the device as a decision-support tool. Any immediate-recall carry-over from the unassisted diagnosis to the assisted diagnosis biases conservatively: readers anchored to their Stage 1 diagnosis are less likely to change it in Stage 2, underestimating rather than overestimating the device's incremental benefit. This design has been applied in three previous MRMC investigations (SAN_2024, BI_2024, PH_2024) using the same methodology.

The three-stage progressive-disclosure protocol evaluated in this investigation reproduces the user-facing outputs that the Instructions For Use mandate of the integrating system: the Top-5 prioritised differential view (Stage 2), the malignancy probability gauge, the referral recommendation and the diagnostic-entropy indicator (Stage 3). The clinical performance measured here is therefore the clinical performance the device guarantees when integrated in accordance with the IFU's integration-requirements section; it is not contingent on integrator design choices. Any integration that omits or demotes these outputs is outside the scope of the clinical evidence generated by this investigation.

Reference standard (ground truth)

The reference standard for top-1 diagnostic accuracy is the published atlas diagnosis — i.e., the diagnosis assigned to each source clinical image by the originating public dermatological atlas from which the case was sourced. Each case's ground-truth diagnosis is encoded as an ICD-11 code and was established prior to and independently of this investigation. The reference standard is not modified or influenced by the device output or by the participating readers' assessments.

Limitations of the reference standard: atlas diagnoses may not all be histopathologically confirmed. However, atlas labels represent expert consensus diagnoses and are a widely accepted reference standard in multi-reader multi-case investigations evaluating diagnostic decision-support tools. The impact of this limitation on accuracy calculations is mitigated by: (1) the size of the image set (149), which limits the influence of any individual misclassified case; (2) the self-controlled design, where both unassisted and assisted conditions are evaluated against the same reference standard, so any reference-standard error affects both arms equally; and (3) the consistency of this approach with the three source investigations (SAN_2024, BI_2024, PH_2024), which used the same reference-standard methodology.

Population

The reader population consists of healthcare professionals (HCPs) representative of the device's declared intended user groups. Per the IFU (Intended Purpose, §Intended user), the device is intended for use by healthcare providers to aid in the assessment of skin structures. The eligible reader categories are accordingly:

• Board-certified dermatologists (specialist in dermatology), or dermatology trainees (residents) in an accredited residency programme.
• Board-certified primary care physicians (specialist in family and community medicine / general practitioners), or primary-care trainees (residents) in an accredited residency programme.
• Registered nurses with clinical responsibility for skin or wound assessment and at least two years of documented professional experience in dermatology, primary care, wound care or a related clinical area.

This reader population reflects the full range of intended users of the device as declared in the IFU and is consistent with the multi-specialty reader populations of the preceding MRMC investigations SAN_2024 and BI_2024, which included general practitioners and dermatologists. The CIP requires a minimum of 5 HCPs in the primary analysis cohort; open recruitment up to approximately 20 HCPs was planned to tighten the confidence intervals on the primary pooled-accuracy endpoint and on pre-specified exploratory per-specialty descriptives. Each participating reader evaluates 149 images through the three-stage progressive-disclosure protocol.

Sample size

The investigation aims to evaluate whether the use of the device improves top-1 diagnostic accuracy by at least 10 percentage points on the curated image set.

Power calculation

The sample size is determined using a two-sided McNemar test for paired binary outcomes (correct/incorrect diagnosis, with and without the device), with the following parameters:

• Baseline accuracy (unassisted): 60%. This is a conservative estimate based on the SotA literature on HCP diagnostic accuracy for multi-condition image-based assessments (R-TF-015-011) and is consistent with the unassisted accuracy observed in the source investigations (SAN_2024, BI_2024, PH_2024).
• Expected accuracy (assisted): 70%. This represents the minimum clinically meaningful improvement of 10 percentage points used as the pre-specified effect size for the curated image set.
• Significance level (alpha): 0.05, two-sided.
• Statistical power (1 − beta): 0.80.
• Discordant proportion: under the assumption that 25% of paired observations are discordant, a minimum of approximately 200 paired observations is required per McNemar test (Lachin, 1992).

Power is computed at the conservative floor of 5 readers × 149 images = 745 paired observations, which is well above the threshold; open recruitment up to approximately 20 HCPs was planned to further tighten the primary-endpoint confidence interval and to support the exploratory per-specialty descriptives. Adjusting for within-reader correlation (ICC ≈ 0.15, consistent with the effective-sample-size observed in the source investigations SAN_2024, BI_2024 and PH_2024), the effective sample size at the 5-reader floor is approximately 460 independent observations, which exceeds the minimum of 200 required. The primary-endpoint conclusion is robust across a sensitivity range of ICC from 0.05 to 0.30.

Dermatological conditions and case distribution

The 149 images represent 28 distinct dermatological conditions, including 10 cases of malignant conditions. The distribution is as follows:

ICD-11 Code	Condition	Images	Risk
EA89	Generalised eczematous dermatitis	13	Benign
ED92.0	Hidradenitis suppurativa	11	Benign
ED80.3	Nodular acne	10	Benign
1B72	Impetigo	9	Benign
EA90.40	Generalised pustular psoriasis	8	Benign
1F28	Dermatophytosis	8	Benign
EA90.0	Plaque psoriasis	7	Benign
ED80.Z	Acne, unspecified	7	Benign
2F20.Z	Melanocytic naevus, unspecified	7	Benign
2C30	Melanoma of skin	7	Malignant
2F21.0	Seborrhoeic keratosis	6	Benign
EA81	Seborrhoeic dermatitis	6	Benign
EB05	Urticaria	6	Benign
EB2Y	Subcorneal pustular dermatosis	5	Benign
EA90.42	Palmoplantar pustulosis	5	Benign
ED80.4	Severe inflammatory acne	5	Benign
EB40	Pemphigus	5	Benign
EH67.0	Acute generalised exanthematous pustulosis	4	Benign
2C32	Basal cell carcinoma of skin	3	Malignant
EA90	Psoriasis	3	Benign
2F20.1	Atypical melanocytic naevus	2	Benign
EK90.0&XH36H6	Actinic keratosis	2	Benign
EA90.4	Pustular psoriasis	2	Benign
ED70	Alopecia	2	Benign
1E91	Herpes zoster	2	Benign
EE12.1	Onychomycosis	2	Benign
EE80.0	Granuloma annulare	1	Benign
EH90.Z	Pressure ulcer	1	Benign

Malignant cases: 10 (6.7 % of total; 7 melanoma and 3 basal cell carcinoma). Benign cases: 139 (93.3 %). ICD-11 codes for Subcorneal pustular dermatosis (EB2Y) and Acute generalised exanthematous pustulosis (EH67.0) are the same codes used in the BI_2024 source investigation. The 10 malignant cases are sufficient to support exploratory descriptive reporting of the Stage 3 referral-decision rate and the device-level malignancy ROC AUC on the curated V–VI image set; they are not sized to support a confirmatory malignancy-specific diagnostic-accuracy or referral-sensitivity claim. Confirmatory malignancy performance is addressed by the dedicated NMSC clinical investigation cited in the Clinical Evaluation Report and by the Post-Market Clinical Follow-up Plan.

Duration

The investigation planning phase began in October 2025. The data-collection phase ran from January to April 2026, followed by database closure (17 April 2026), analysis and preparation of the Clinical Investigation Report.

Acceptance criteria

The table below lists every pre-specified acceptance criterion for this investigation. For each criterion it states: the metric (top-1 diagnostic accuracy, malignancy ROC AUC, referral-decision rate, etc.), the analysis population (primary cohort, board-certified subset, per-specialty stratum), the threshold type (absolute-value or relative-change), the numerical threshold, and the primary / secondary / exploratory designation. The single primary confirmatory criterion is the paired +10 percentage-point improvement in pooled top-1 diagnostic accuracy (Stage 1 unassisted vs Stage 2 device-assisted) on the primary analysis cohort, tested using a two-sided McNemar test for paired proportions at α = 0.05. All remaining criteria are pre-specified as secondary or exploratory descriptives. The table is rendered as a static tabular figure in the exported PDF.

• top-1 accuracy equal to or greater than 10.00%.(User Group: Dermatologists, Primary care practitioners)
• top-1 accuracy equal to or greater than 60.00%.(User Group: Dermatologists, Primary care practitioners)
• sensitivity equal to or greater than 90.00%.(User Group: Dermatologists, Primary care practitioners)

Justification of acceptance thresholds

The acceptance thresholds listed in the table above are not set ad hoc; each is derived from the formal State-of-the-Art record R-TF-015-011 State of the Art, which constitutes the authoritative source of the state-of-the-art benchmarks referenced in this investigation. That record documents the systematic review, selection criteria and meta-analytic synthesis of the SotA literature from which the thresholds are derived, and explains the choice of metrics for the device's intended use. The relationship between each threshold and the SotA record is as follows:

• Absolute-value ("absoluteValue") thresholds — for example, the pooled "with-device" top-1 diagnostic-accuracy target on the curated image set — are set to match or exceed the SotA meta-analytic baselines for aided-HCP performance reported in R-TF-015-011, so that the device's post-intervention metric is competitive with the current clinical state of the art.
• Relative-change ("relativeChange") thresholds — for example, the paired improvement in HCP top-1 diagnostic accuracy attributable to the use of the device — are set at approximately a minimum of +10 percentage points on the curated image set, consistent with the methodology documented in R-TF-015-011 §"Methodology for Establishing Acceptance Criteria", which sets the device's acceptance target approximately ten percentage points higher than the SotA-averaged AI-aided improvement baseline (overall HCP +6.36%; PCP +9.30%; dermatologist +5.30%). Setting the acceptance criterion above the SotA AI-aided baseline is the mechanism by which the investigation tests the "substantial clinical benefit" positioning required under MDCG 2020-1.
• Primary vs secondary designation. The primary confirmatory endpoint is the paired +10% improvement in pooled top-1 diagnostic accuracy tested using McNemar's test for paired proportions on the curated image set; the sample size in this investigation is powered only for this pooled-accuracy comparison. All remaining thresholds in the table above are pre-specified as secondary or supporting; statistical comparisons against these thresholds at the per-pathology or per-specialty stratum level are exploratory, hypothesis-generating and are not used to support confirmatory claims (see §Statistical analysis).

For the full systematic review, literature inclusion criteria, meta-analytic synthesis and per-metric derivations, refer to R-TF-015-011 (held by the manufacturer within the technical file).

Inclusion criteria

Reader (HCP) inclusion criteria. To be eligible, a reader must satisfy all of the following:

• Belong to one of the device's declared intended user groups, namely: (a) board-certified dermatologists or dermatology residents in an accredited residency programme; (b) board-certified primary care / family and community medicine physicians or primary-care residents in an accredited residency programme; or (c) registered nurses with clinical responsibility for skin or wound assessment and at least two years of documented professional experience in dermatology, primary care, wound care or a related clinical area.
• Have a clinical scope of practice that routinely includes the assessment of skin conditions.
• Complete the investigation onboarding flow: professional-profile form, CV, evidence of board certification or current training, conflict-of-interest declaration, signed participation agreement and data-protection acknowledgement.

Image inclusion criteria:

• Anonymised images representative of Fitzpatrick phototype V or VI presentations of one of the pre-specified dermatological conditions, which have passed the per-image quality-control review.

Exclusion criteria

Reader (HCP) exclusion criteria. A reader is screened out and any data collected from them is excluded from the primary analysis if any of the following applies:

• The reader's current specialty or scope of practice does not routinely include the clinical assessment of skin conditions. Examples of excluded specialties include anatomical pathology, clinical neurophysiology, radiology, laboratory medicine and purely non-clinical administrative roles. Dermatopathology is eligible only where the practitioner documents active involvement in clinical dermatological assessment, not solely histological review.
• A conflict of interest is declared that cannot be adequately managed under the conflict-of-interest handling procedure.
• The onboarding flow is not completed.

Image exclusion criteria:

• Images of insufficient quality for proper analysis after the quality-control review.
• Images in which the skin-condition morphology has been altered beyond clinical recognition.

Variables

Main variable

The main variable of this investigation is pooled top-1 diagnostic accuracy on the curated image set, measured per reader per case against the atlas-labelled reference-standard diagnosis (ICD-11 code), with and without the device.

Secondary variables

• Top-5 differential-diagnosis accuracy on the curated image set, measured against the reference-standard diagnosis. The device displays its top-5 differential to the reader during Stage 2 in order to support the reader's revised top-1 selection; top-5 accuracy at the device level is reported as a secondary variable describing the information presented to the reader, not as a reader-level outcome.
• Proportion of cases for which the reader, with the device's output available, considers that specialist referral is appropriate (Stage 3).
• Device malignancy-detection performance (ROC AUC) at the case level against the atlas-labelled ground truth.

Condition of interest

Dermatological conditions presented on Fitzpatrick phototype V–VI skin, as represented in anonymised images sourced from public dermatological atlases. Twenty-eight distinct conditions are represented, including both malignant (melanoma, basal cell carcinoma) and benign presentations.

Limitations of clinical research

The main limitations of the investigation include several factors that may influence the perception and effectiveness of the device when used as a decision-support tool. First, the acceptance and trust of healthcare professionals in AI-based diagnostic decision-support tools can vary significantly. The device's effectiveness may be compromised if users are not fully convinced of its accuracy or usefulness, thereby affecting the overall perception of its performance.

Image quality is crucial for the device's performance. Variations in lighting and focus in the source images can deteriorate the quality of the data received by the system, which may negatively influence the evaluation and perception of its effectiveness.

The consistency of readers in using the device is also crucial. Variations in how diligently readers inspect the device's Stage 2 and Stage 3 output can impact the investigation's findings. A standardised onboarding flow and a standardised three-stage progressive-disclosure protocol are used to mitigate this source of variability; residual variation is acknowledged.

Another limitation is the Hawthorne effect, where participants may change their behaviour because they know they are being observed. This awareness can influence their decisions and actions within the investigation, potentially skewing the results. The within-reader paired design mitigates this because the effect applies equally to the unassisted and assisted conditions.

The image set is sourced from public dermatological atlases. This investigation provides simulated-use evidence on real clinical cases; real-world Fitzpatrick V and VI patient-outcome evidence is outside the scope of this investigation and is addressed at Clinical Evaluation Report level through Post-Market Clinical Follow-up.

Under MDCG 2020-6 Appendix III, simulated-use multi-reader multi-case (MRMC) studies conducted on retrospective anonymised images constitute Rank 11 evidence and are distinct from clinical data generated on real patients within the meaning of MDR Article 2(48). The positioning of this investigation within the overall body of clinical evidence is documented in the Clinical Evaluation Plan and Clinical Evaluation Report.

Ethical considerations

This study adhered to international Good Clinical Practice (GCP) guidelines, the Declaration of Helsinki in its latest amendment, and applicable international and national regulations. As applicable, approval from the relevant Ethics Committee was obtained prior to the initiation of the study. When applicable, modifications to the protocol were reviewed and approved by the Principal Investigator (PI) and subsequently evaluated by the Ethics Committee before subjects were enrolled under a modified protocol.

This study was conducted in compliance with European Regulation 2016/679, of 27 April, concerning the protection of natural persons with regard to the processing of personal data and the free movement of such data (General Data Protection Regulation, GDPR), and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and the guarantee of digital rights. In accordance with these regulations, no data enabling the personal identification of participants was collected, and all information was managed securely in an encrypted format.

Participants were informed both orally and in writing about all relevant aspects of the study, with the information being tailored to their level of understanding. They were provided with a copy of the informed consent form and the accompanying patient information sheet. Adequate time was given to patients to ask questions and fully comprehend the details of the study before providing their consent.

The PI was responsible for the preparation of the informed consent form, ensuring it included all elements required by the International Conference on Harmonisation (ICH), adhered to current regulatory guidelines, and complied with the ethical principles of GCP and the Declaration of Helsinki.

The original signed informed consent forms were securely stored in a restricted access area under the custody of the PI. These documents remained at the research site at all times. Participants were provided with a copy of their signed consent form for their records.

Data confidentiality

Current legislation will be complied with in terms of data confidentiality protection (European Regulation 2016/679, of 27 April, on the protection of natural persons with regard to the processing of personal data and the free movement of such data and Organic Law 3/2018, of 5 December, on Personal Data Protection and guarantee of digital rights). For this purpose, when applicable, each participant will receive an alphanumeric identification code in the study that will not include any data allowing personal identification (coded CRD). The Principal Investigator will have an independent list that will allow the connection of the identification codes of the patients participating in the study with their clinical and personal data. This document will be filed in a secure area with restricted access, under the custody of the Principal Investigator and will never leave the centre.

Once the paper CRDs are completed and closed by the Principal Investigator, the data will be transferred to a database.

As in the CRDs, the Database will comply with current legislation in terms of data confidentiality protection (European Regulation 2016/679, of 27 April, on the protection of natural persons about the processing of personal data and the free movement of such data and Organic Law 3/2018, of 5 December, on the Protection of Personal Data and guarantee of digital rights) in which no data allowing personal identification of patients will be included.

Bias minimization measures

Minimising bias is essential to ensure the validity and reliability of the investigation's results. Participating HCPs are invited directly on the basis of professional qualification (board-certified dermatologists, primary care / family and community medicine physicians or nurses with clinical responsibility for skin or wound assessment); random selection of HCPs from a larger pool is not performed and is not claimed. Bias controls implemented by design include the following:

• Standardised data-collection protocols, applied uniformly to every participating reader, so that the conditions under which each reader is exposed to the device are identical.
• Prospective pre-specification of primary and secondary outcomes before the investigation begins, which prevents selective reporting of only favourable outcomes.
• A self-controlled design in which each reader serves as their own comparator: the same reader first provides a top-1 diagnosis without the device (Stage 1) and subsequently revises the top-1 diagnosis with the device's output available (Stage 2) on the same case, eliminating between-reader confounding as a source of bias.
• Case-order randomisation across readers to limit systematic order effects.
• Sequential separation of the Stage 1 and Stage 2 reads within each case, so that the unassisted diagnosis is recorded before the reader sees any device output, preventing information leakage between conditions.
• Prospective data capture on a timestamped secure platform with access logs, reducing the chance of inaccurate recall of past events relative to retrospective designs.

Known residual sources of bias that cannot be fully controlled by design in this kind of MRMC investigation (immediate-recall carry-over within a reader, reader expectation effects in simulated environments, Hawthorne effect) are acknowledged in the Limitations section.

Calendar

The investigation data-collection phase spans approximately three months, followed by database closure and editing, data analysis and preparation of the Clinical Investigation Report. Realised dates for the present investigation are: planning phase from October 2025; data-collection phase from 21 January 2026 to 17 April 2026; database closure and data lock on 17 April 2026; analysis and Clinical Investigation Report drafting from 17 April 2026 onwards.

Monitoring plan

The sponsor will hold a meeting with the investigative team at the beginning of the study to address any potential questions and ensure that data is being collected properly.

The clinical investigation will be monitored by a designated clinical monitor, who is independent of the investigational site and appointed by the sponsor. The purpose of monitoring is to ensure that:

• The rights, safety, and well-being of the subjects are protected.
• The data reported are accurate, complete, and verifiable from source documents.
• The clinical investigation is conducted in compliance with the Clinical Investigation Plan (CIP), applicable regulatory requirements (including Regulation (EU) 2017/745), and ISO14155:2020.

In this way, monitoring will be performed through:

• Remote monitoring activities: Including scheduled video or telephone meetings every 3 months with the investigators to review study progress, discuss challenges, and ensure ongoing compliance.
• On-site visits: If deemed necessary based on data review, protocol deviations, or issues raised during remote monitoring. In this study, this will be carried out online.
• Source data verification (SDV): The sponsor in this case has secure access to anonymised source documents (e.g., image files, clinical assessment records) via encrypted digital platforms or controlled site systems to verify data accuracy and consistency with Case Report Forms (CRFs).
• Risk-based monitoring approach: The extent and frequency of monitoring activities will be adapted to the complexity and risk level of the investigation. Given that this study does not involve significant deviation from routine care, the monitoring will be primarily remote unless specific issues arise.

All monitoring activities will be documented in monitoring visit reports. Any protocol deviations or non-compliance identified will be documented, assessed for impact, and communicated promptly to the sponsor. Corrective actions will be tracked and followed up by the monitor or the sponsor.

Completion of the investigation

After the final closure of the clinical investigation, a Clinical Investigation Report (R-TF-015-006) is drafted, even in the event of early termination or suspension. The results obtained (positive, inconclusive or negative) are documented. If deemed appropriate, the results may be published in scientific journals with acknowledgement of all investigators who approved this clinical investigation and disclosure of any funding received.

Statistical analysis

Pre-specified analyses

The primary endpoint is the paired difference in top-1 diagnostic accuracy (per reader, per case, correct vs incorrect against the atlas-labelled reference standard) between Stage 1 (unassisted) and Stage 2 (assisted), pooled across all readers in the primary analysis population. This paired binary outcome is analysed using McNemar's test for paired proportions, with a two-sided alpha of 0.05. Wilson score 95% confidence intervals are reported for each stage-specific accuracy; differences in paired proportions are reported with their Newcombe hybrid-score 95% confidence intervals.

The pre-specified secondary endpoints are reported as exploratory descriptives (not used to support confirmatory claims on this investigation alone):

• The proportion of cases for which the reader, with the device's output available, considers that specialist referral is appropriate (Stage 3), reported split by malignant and benign atlas-labelled ground truth with Wilson score 95 % confidence intervals. Given that the image set contains only 10 malignant cases, the Stage 3 malignant-case referral rate is a descriptive safety-relevant observation, not a confirmatory statistical claim; the dedicated NMSC clinical investigation referenced in the Clinical Evaluation Report provides the confirmatory malignancy evidence.
• The device-level malignancy-detection ROC AUC against the atlas-labelled ground truth, reported as a descriptive point estimate with its 95 % confidence interval, for comparability with the case-level malignancy output behaviour observed on other investigation image sets.

Exploratory and hypothesis-generating analyses

Per-pathology analyses (comparing accuracy before and after device exposure, stratified by condition) and per-specialty analyses (dermatology, primary care, nursing) are pre-specified as exploratory, hypothesis-generating analyses. Because the sample size is powered only for the primary pooled-accuracy comparison and not for per-stratum comparisons, and because no adjustment for multiple comparisons is applied at this stratification level, p-values from these per-pathology and per-specialty contrasts are reported for descriptive purposes and are not used to support confirmatory claims. Where a per-pathology cell contains fewer than 15 observations, the cell is flagged as having limited interpretability.

Stage 3 referral decisions split by malignant and benign ground truth, and a board-certified subset sensitivity analysis, are also reported as descriptive.

Handling of incomplete reader data

The pre-specified primary analysis population comprises all cases reviewed by any enrolled HCP under the Stage 1 → Stage 2 paired protocol (analysis at the paired-observation level, not at the reader level). Readers who complete only a partial number of cases contribute the observations they did complete. A sensitivity analysis restricted to HCPs who completed at least 50% of the 149 cases, and a further sensitivity analysis restricted to HCPs who completed all 149 cases, are performed and reported; the primary result is considered robust if the direction and magnitude of the estimated effect are preserved across both sensitivity analyses. Readers who fail the CIP §Exclusion criteria at screening are excluded from the primary analysis, from the board-certified subset and from all per-specialty breakdowns.

Software

Analyses are performed using a deterministic, version-controlled statistical analytics environment maintained by the manufacturer, applying the pre-specified statistical methods to the de-identified exported dataset. All analytical code is held under version control and is available for audit on request.

Data management

All investigation data are collected and managed through a centralised, secure web-based platform operated by the manufacturer that serves as the electronic Case Report Form (eCRF). Each participating reader receives individual login credentials (username and password) to access the platform. The platform presents the standardised set of 149 images to each reader and captures diagnostic assessments and referral decisions in response to structured questions.

Data collection

Stage 1, Stage 2 and Stage 3 responses are captured directly in the platform when readers provide their responses. All data entries are time-stamped and automatically stored in the secure central database.

Access control and traceability

Access to the platform is restricted to authorised readers through individual user credentials. Complete access logs are maintained for each reader, documenting login times, data-entry activities and timestamps of all interactions. This audit trail ensures full traceability of who accessed what data and when.

Data anonymity

Investigation images are fully anonymised and bear no patient identifiers. Each reader receives a unique investigation identification code that is not linked to their personal identity in the analysis dataset. The Principal Investigator maintains a confidential list linking reader identification codes to reader identities, stored separately in a secure area with restricted access.

Data export and analysis

Once data collection is completed and the database is closed and locked by the Principal Investigator, data are exported to a de-identified tabular format for statistical analysis. The exported dataset contains only anonymised image data and reader responses, with no personal identifying information.

Data security

All data transmitted to and stored on the platform are encrypted using industry-standard security protocols. Access to the central database is restricted to authorised personnel only, and the system implements appropriate technical and organisational measures to prevent unauthorised access, alteration or loss of data.

CIP Modification

As indicated in the UNE-EN ISO 14155:2021 standard, the Clinical Investigation Plan (CIP) may be modified as necessary during the clinical investigation. The changes made must be described, along with their justification, potential impact on clinical performance, efficacy, safety, or other evaluation criteria, and identification of other affected documents.

CIP modifications will be prepared by the sponsor and agreed upon and accepted between the sponsor and the principal investigator. The modifications will be recorded with a justification for each one in the form of an amendment or addendum.

The required regulatory authority (AEMPS) and the Ethics Committee or Institutional Review Board (IRB) will be notified, if necessary. Modifications to the clinical investigation may only be implemented once favourable feedback and the corresponding approval have been obtained.

In accordance with Article 75 of Regulation (EU) 2017/745, substantial modifications to the clinical investigation must be approved by both the Ethics Committee for investigation with medicines (CEIm) and the Competent Authority (AEMPS) prior to their implementation.

• In the case of substantial modifications to authorized clinical investigations, a request must be submitted to the AEMPS and the CEIm.
• For non-substantial modifications to authorized clinical investigations, until the corresponding module is available in the EUDAMED database, the updated documentation will be sent to the AEMPS for inclusion in their file.

CIP Deviations

As indicated in the UNE-EN ISO 14155:2021 standard, the investigator may not deviate from the Clinical Investigation Plan (CIP), except in emergencies (section 4.5.4.b of the standard). In such cases, the investigator may proceed without prior approval from the sponsor and the Ethics Committee to protect the rights, safety, and well-being of human subjects. The use of waivers from the Clinical Investigation Plan is strictly prohibited.

These deviations must be documented by the principal investigator and notified to the sponsor and the IRB as soon as possible, and always within a maximum of 15 days. Immediately after receiving the notification, the sponsor will record and analyze the deviations carried out and their potential impact. Depending on the findings, the sponsor will take the necessary corrective and/or preventive measures.

In other circumstances, when deviations affect the rights, safety, and well-being of the subject or the scientific integrity of the clinical investigation, deviation requests and reports must be provided to the IRB if required.

Start, follow-up and end reports

The start of the investigation is notified to the Principal Investigator and all the participating investigators. Upon obtaining the investigation conclusions, a final report (R-TF-015-006) is prepared and submitted to the sponsor.

Statements of compliance

The present clinical investigation will be conducted following the ethical principles originating from the Declaration of Helsinki.

Additionally, the clinical investigation will comply with the harmonized standard UNE-EN ISO 14155:2021 and the European Regulation MDR 2017/745. The statement specifying compliance with the general safety and performance requirements in accordance with MDR can be found in the document Manufacturer's Declaration of Compliance with Requirements.

As appropiate, clinical investigation will not commence until approval/favourable opinion has been obtained from the Clinical Research Ethics Committee (CREC) and the required regulatory authority (Spanish Agency for Medicines and Medical Devices, AEMPS), and it must comply with any additional requirements imposed by the CREC and/or AEMPS.

Informed Consent process

For patients / image subjects

Informed consent from patients whose images might appear in the source atlases is not required for this investigation because: (1) the investigation uses fully anonymised images sourced from public dermatological atlases, where individuals cannot be identified; (2) there is no active patient recruitment or direct involvement of patients; (3) the images constitute non-personal data under GDPR as they contain no information allowing identification of data subjects; and (4) the investigation does not involve any intervention, modification of care or processing of sensitive personal health data.

For healthcare professionals

While formal Informed Consent Forms are not required for reader participants (this investigation is observational and non-interventional with respect to their clinical practice), all participating HCPs receive comprehensive written and oral information about the investigation before commencing their participation. The information provided includes:

• Investigation objectives and design.
• Investigation procedures, including the three-stage progressive-disclosure protocol and the expected time commitment.
• The voluntary nature of participation and the right to withdraw at any time without justification.
• Data-handling practices, including anonymisation of reader responses and confidentiality protections.
• Sponsor contact information for questions or concerns.

Each participating reader signs a participation agreement with the sponsor that formalises their involvement, outlines their obligations and confirms their understanding and voluntary agreement to participate.

Adverse events, adverse product reactions and product deficiencies

Adverse Events (AE) and Adverse Events to the Product (AEP)

An AE is any unintended medical event, unanticipated illness or injury, or unintended clinical signs (including abnormal laboratory findings) in subjects, users or other persons, whether or not related to the investigational product and whether intended or unintended.

An AEP is an adverse event related to the use of an investigational medical device.

Given these definitions, potential AEPs or AEs are documented in the product's IFU.

Product deficiencies

Possible inadequacies of a medical device may relate to its identity, quality, durability, reliability, safety or performance. Product deficiencies identified during the investigation are managed by the sponsor according to non-conforming product control procedures. When appropriate, corrective and/or preventive actions are taken to protect the safety of subjects, users and other individuals.

Serious Adverse Events, serious adverse events to the product and serious and unexpected adverse events to the product

According to UNE-EN ISO 14155:2021:

• A Serious Adverse Product Reaction (SAEP) is a SAE that has produced any consequence characteristic of a serious adverse event.
• A Serious Adverse Event (SAE) is an AE that resulted in any of the following events: death, serious deterioration of the health status of the subject, users or other persons, fetal distress, fetal death, congenital anomaly or birth defect.
• A Serious Unexpected Adverse Event to the Product (SUAEP) is a SAE that, due to its nature, incidence, intensity or consequences, has not been identified in the updated risk assessment.

Given these definitions, no SAEP, SAEs or SUAEPs are expected in relation to the use of the product in this non-interventional investigation.

Foreseeable adverse events and adverse events to the product

The foreseeable adverse events and expected adverse reactions to the product, as well as their incidence, mitigation and treatment, are documented in R-TF-013-002 Risk Management Record of the product under study.

Data Monitoring Committee (DMC)

A Data Monitoring Committee is not established for this investigation. This decision is justified because: (1) the investigation is non-interventional and does not affect patient care or safety; (2) no patients are involved — the participants are healthcare professionals providing diagnostic assessments; (3) there are no safety endpoints to monitor; and (4) the investigation duration and design do not warrant interim analyses for safety or futility.

Suspension or early termination of clinical research

As indicated in the UNE-EN ISO 14155:2021 regulation, the sponsor may suspend or terminate the clinical research early for significant and documented reasons. These are:

• If during the clinical research the suspicion of an unacceptable risk arises, including a serious threat to the health of the subjects. It must be suspended while the risk is determined.
• If an unacceptable risk that cannot be controlled is confirmed.
• Due to the impossibility of including a minimum number of subjects that allows the final assessment of the study within a reasonable period according to the characteristics of the study.
• When instructed by the IRB or the required regulatory authority (AEMPS).
• Due to non-compliance with the obligations assumed in the contract by any of the contracting parties.
• By mutual agreement between the parties, expressed in writing.
• By the will of one of the parties, expressed in writing at least one month in advance.

In the event of a suspension or early termination of the clinical research, the sponsor will inform the AEMPS. The sponsor must provide the resources to comply with the obligations of the CIP and with the existing agreements. The principal investigator must inform the subjects if so stipulated in the agreement between the sponsor and the research centre.

If the clinical investigation is resumed, the sponsor must inform the principal investigator and, where appropriate, the AEMPS. Approval from the IRB and, where appropriate, from the AEMPS will be required for such resumption. The principal investigator must inform the subjects.

In accordance with Article 77 of Regulation (EU) 2017/745, the sponsor must notify the Member States in which the clinical investigation is being conducted of the end of the clinical investigation, its temporary halt, or its early termination, within the deadlines specified by the regulation (within 15 days of the end, or within 24 hours in case of early termination or temporary halt for safety reasons). This notification must be accompanied by a justification in case of early termination or temporary halt.

Signature meaning

The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:

• Author: Team members involved
• Reviewer: JD-018 Clinical Research Coordinator
• Approver: JD-022 Medical Manager