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  • Welcome to your QMS
  • Quality Manual
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  • Legit.Health Plus Version 1.1.0.0
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  • BSI Non-Conformities
    • Technical Review
    • Clinical Review
      • Round 1
        • Item 1: CER Update Frequency
        • Item 2: Device Description & Claims
        • Item 3: Clinical Data
          • Request A: Clinical Data Analysis
            • Question
            • Research and planning
            • Response
            • Information_for_answers
          • Request B: Data Sufficiency Justification
        • Item 4: Usability
        • Item 5: PMS Plan
        • Item 6: PMCF Plan
        • Item 7: Risk
    • BSI Non-Conformities
  • Pricing
  • Public tenders
  • BSI Non-Conformities
  • Clinical Review
  • Round 1
  • Item 3: Clinical Data
  • Request A: Clinical Data Analysis
  • Information_for_answers

Information_for_answers

The purpose of this document is to answer your questions and address the deficiencies identified by the BSI auditor in Item 3a. This document should serve as a source of context for your questions and help you respond to the BSI auditor regarding Item 3a, as well as provide any other necessary clarifications. it is important to highlight that if this information is not inserted in the Clinical Investigation Plan or Clinical investigation Report of the studies, it should be added in these documents with the corresponding redline, and the reference to the section/page where this information is included should be provided in the answer to BSI.

  1. AEMPS Communications & Ethics Approval: BSI asks if there was communication with the competent authority. For all 8 pivotal studies (MC_EVCDAO_2019, IDEI_2023, COVIDX_EVCDAO_2022, DAO_Derivacion_O/PH_2022, BI_2024, PH_2024, SAN_2024):
    • Were they notified to AEMPS? If so, what was the classification (clinical investigation vs observational)?
    • Do we have the ethics committee (CEIC/CEIm) approval references and dates for these?
  • Yes, as it is explained in the document "R-TF-015-011" of every study, some required approval from an Ethics Committee while others did not (being exempt). For those that required it, the date of the approval and the reference number have been added to the respective Clinical Investigation Plan (CIP) and Clinical Investigation Report (CIR) documents. For those that were exempt, the justification is included in the document "R-TF-015-011" of each respective study folder. The data and references are the following:
  • COVIDX_EVCDAO_2022: Approved by CEIm of Torrevieja and Elche-Vinalopó hospitals on 2022-04-13, reference number 12/04/22 LEGIT_COVIDX.
  • DAO_Derivacion_O_2022: Approved by CEIm of Euskadi on 2022-11-23, reference number PS2022074.
  • DAO_Derivacion_PH_2022: Approved by CEIm of Puerta de Hierro University Hospital on 2022-06-24, reference number 47/395984.9/22.
  • IDEI_2023: Approved by CEIm of HM Hospitals on 2024-01-25, reference number 24.12.2266-GHM.
  • MC_EVCDAO_2019: Approved by CEIm of Euskadi on 2022-01-13, reference number PI2019216. The rest of the studies did not require an approval from Ethics Committee, and the justification is included in the document "R-TF-015-011" of every study, which is included in the folder of each study. AIHS4 2025 is a different case, since it analyzes data from a clinical trial that was performed by a third party, and for which patients otorgued their informed consent to use their data with investigational aims. However, the justification for not having this information is included in the document "R-TF-015-011" of the study AIHS4 2025, which is included in the folder of the study.
  1. ClinicalTrials.gov Registration: The CER mentions two records (IDEI_2023 and COVIDX_2022).
    • What are the NCT numbers?
    • Were any of the other studies registered?
  • Yes all the studies were registered in both ClinicalTrials.gov and RWD Catalogue of EMA. The identification numbers are the following:
  • IDEI_2023: NTC05656709 (ClinicalTrials.gov), EUPAS1000000045 (RWD Catalogue of EMA)
  • COVIDX_EVCDAO_2022: NCT06237036 (ClinicalTrials.gov), EUPAS108260 (RWD Catalogue of EMA)
  • DAO_Derivacion_O_2022: NCT06228014 (ClinicalTrials.gov), EUPAS108167 (RWD Catalogue of EMA)
  • LEGIT_MC_EVCDAO_2019: NCT06221397 (ClinicalTrials.gov), EUPAS108254 (RWD Catalogue of EMA)
  • SAN_2024: NCT07428954 (ClinicalTrials.gov), EUPAS1000000911 (RWD Catalogue of EMA)
  • PH_2024: NCT07428941 (ClinicalTrials.gov), EUPAS1000000644 (RWD Catalogue of EMA)
  • BI_2024: NCT07428915 (ClinicalTrials.gov), EUPAS1000000910 (RWD Catalogue of EMA)
  • DAO_Derivacion_PH_2022: NCT07429123 (ClinicalTrials.gov), EUPAS108166 (RWD Catalogue of EMA)
  1. Publication Status: Have any of these clinical investigations been published in peer-reviewed journals (or are manuscripts currently under review)?
  • Yes, the results of the study BI_2024 have been recently published in a peer-reviewed journal under the title "Enhanced Diagnosis of Generalised Pustular Psoriasis: Multi-Reader Multi-Case Evaluation of the Legit.Health Device as a Diagnosis Support Tool" in the Journal "JMIR Dermatology Journal". As soon as we've got the referece, we will attach it. The study IDEI_2023 has been also published under the title "Diagnostic accuracy in detecting malignancy in suspicious skin lesions using Artificial Intelligence", with the doi: doi: https://doi.org/10.1101/2025.03.11.25323753. The manuscript MC_EVCDAO_2019 is currently under review in a peer-reviewed journal, and we expect to have the confirmation soon. The rest of the studies have not been published yet, but we are planning to publish them in the following months.
  1. Fitzpatrick Skin Type Data: BSI asks about representative patient populations (pigment). Do any of the studies have Fitzpatrick skin type data for enrolled patients, or any other proxy for skin pigmentation diversity?

  • Yes, almost all the studies have Fitzpatrick skin type data for enrolled patients, which is included in the corresponding Clinical Investigation Report (CIR) of each study (if not, included). However, it is necessary to add in the CIRs a reference to the section/page where this information is included. The data is the following:

  • BI_2024 Gender: Men: 64 (63.4%), Women: 37 (36.6%) Age: Mean: N/A, SD: N/A Age Blocks: Newborn (birth to 1 month): 0 (0.0%) 1 month to 2 years: 3 (3.0%) 2 to 12 years: 14 (13.9%) 12 to 21 years: 20 (19.8%) Age ≥ 22 and < 65: 52 (51.5%) Age ≥ 65: 12 (11.9%) Phototypes: Phototype I: 20 (20.0%) Phototype II: 43 (43.0%) Phototype III: 22 (22.0%) Phototype IV: 9 (9.0%) Phototype V: 6 (6.0%) Phototype VI: 0 (0.0%)

  • IDEI_2023 Gender: Men: 56 (27.5%), Women: 148 (72.5%) Age: Mean: 53.84, SD: 21.53 Age Blocks: Newborn (birth to 1 month): 0 (0.0%) 1 month to 2 years: 0 (0.0%) 2 to 12 years: 0 (0.0%) 12 to 21 years: 3 (1.5%) Age ≥ 22 and < 65: 141 (69.1%) Age ≥ 65: 60 (29.4%) Phototypes: Phototype I: 129 (63.4%) Phototype II: 47 (23.2%) Phototype III: 26 (12.5%) Phototype IV: 2 (0.9%) Phototype V: 0 (0.0%) Phototype VI: 0 (0.0%)

  • MC_EVCDAO_2019 Gender: Men: 53 (50.5%), Women: 52 (49.5%) Age: Mean: 62.10, SD: 15.30 Age Blocks: Newborn (birth to 1 month): 0 (0.0%) 1 month to 2 years: 0 (0.0%) 2 to 12 years: 0 (0.0%) 12 to 21 years: 2 (1.9%) Age ≥ 22 and < 65: 56 (53.3%) Age ≥ 65: 47 (44.8%) Phototypes: Phototype I: 91 (87.1%) Phototype II: 10 (9.8%) Phototype III: 3 (2.5%) Phototype IV: 1 (0.6%) Phototype V: 0 (0.0%) Phototype VI: 0 (0.0%)

  • PH_2024 Gender: Men: 14 (46.7%), Women: 16 (53.3%) Age: Mean: N/A, SD: N/A Age Blocks: Newborn (birth to 1 month): 1 (3.3%) 1 month to 2 years: 1 (3.3%) 2 to 12 years: 0 (0.0%) 12 to 21 years: 0 (0.0%) Age ≥ 22 and < 65: 21 (70.0%) Age ≥ 65: 7 (23.3%) Phototypes: Phototype I: 10 (33.3%) Phototype II: 12 (40.0%) Phototype III: 7 (23.3%) Phototype IV: 1 (3.3%) Phototype V: 0 (0.0%) Phototype VI: 0 (0.0%)

  • SAN_2024 Gender: Men: 17 (60.7%), Women: 11 (39.3%) Age: Mean: N/A, SD: N/A Age Blocks: Newborn (birth to 1 month): 0 (0.0%) 1 month to 2 years: 1 (3.6%) 2 to 12 years: 1 (3.6%) 12 to 21 years: 4 (14.3%) Age ≥ 22 and < 65: 18 (64.3%) Age ≥ 65: 4 (14.3%) Phototypes: Phototype I: 12 (42.8%) Phototype II: 12 (42.8%) Phototype III: 2 (7.2%) Phototype IV: 1 (3.6%) Phototype V: 1 (3.6%) Phototype VI: 0 (0.0%)

  • DAO_Derivación_PH_2022 Gender: Men: N/A, Women: N/A Age: Mean: N/A, SD: N/A Age Blocks: Newborn (birth to 1 month): N/A 1 month to 2 years: N/A 2 to 12 years: N/A 12 to 21 years: N/A Age ≥ 22 and < 65: N/A Age ≥ 65: N/A Phototypes: Phototype I: 63 (48.3%) Phototype II: 48 (36.7%) Phototype III: 16 (12.2%) Phototype IV: 3 (2.2%) Phototype V: 1 (0.6%) Phototype VI: 0 (0.0%)

  • DAO_Derivation_O_2022 Gender: Men: 46 (36.2%), Women: 81 (63.8%) Age: Mean: 59.89, SD: 20.70 Age Blocks: Newborn (birth to 1 month): 0 (0.0%) 1 month to 2 years: 0 (0.0%) 2 to 12 years: 0 (0.0%) 12 to 21 years: 3 (2.4%) Age ≥ 22 and < 65: 58 (45.7%) Age ≥ 65: 66 (52.0%) Phototypes: Phototype I: 86 (67.7%) Phototype II: 29 (22.9%) Phototype III: 9 (7.5%) Phototype IV: 2 (1.5%) Phototype V: 1 (0.5%) Phototype VI: 0 (0.0%)

  • COVIDX_EVCDAO_2022 Gender: Men: 63 (39.6%), Women: 97 (60.4%) Age: Mean: N/A, SD: N/A Age Blocks: Newborn (birth to 1 month): N/A 1 month to 2 years: N/A 2 to 12 years: N/A 12 to 21 years: N/A Age ≥ 22 and < 65: N/A Age ≥ 65: N/A Phototypes: Phototype I: 79 (49.3%) Phototype II: 62 (38.5%) Phototype III: 17 (10.9%) Phototype IV: 2 (1.3%) Phototype V: 0 (0.0%) Phototype VI: 0 (0.0%)

If any of this information is not present in their respective Clinical Investigation Plans or Clinical Investigation Reports, it should be added to these documents with the corresponding redline, and the reference to the section/page where this information is included should be provided in the answer to BSI.

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