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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • CAPA Plan - BSI CE Mark Closeout
    • Index
    • Overview and Device Description
    • Information provided by the Manufacturer
    • Design and Manufacturing Information
    • GSPR
    • Benefit-Risk Analysis and Risk Management
    • Product Verification and Validation
      • Software
      • Artificial Intelligence
      • Cybersecurity
      • Usability and Human Factors Engineering
        • Usability Testing Documentation Guide
        • R-TF-025-001 Usability plan
        • R-TF-025-002 Identification of characteristics for safety and possible use errors
        • R-TF-025-003 User interface evaluation plan
        • R-TF-025-004 Summative evaluation protocol
        • R-TF-025-005 Summative Evaluation Observation Form
        • R-TF-025-006 Summative Evaluation Questionnaire
          • R-TF-025-006-HCP Summative Evaluation Questionnaire (HCP)
          • R-TF-025-006-ITP Summative Evaluation Questionnaire (ITP)
          • QR Codes
          • English Self-Reported Usability Testing Questionnaire
          • Cuestionario de Pruebas de Usabilidad Auto-reportado en Español
        • R-TF-025-007 Summative Evaluation Report
        • Deprecated
      • Clinical
      • Commissioning
    • Post-Market Surveillance
  • Legit.Health Plus Version 1.1.0.1
  • Legit.Health Utilities
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Pricing
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Product Verification and Validation
  • Usability and Human Factors Engineering
  • R-TF-025-006 Summative Evaluation Questionnaire
  • R-TF-025-006-HCP Summative Evaluation Questionnaire (HCP)

R-TF-025-006-HCP Summative Evaluation Questionnaire (HCP)

Document Information​

FieldValue
Document IDR-TF-025-006-HCP
Document TypeRecord (Usability Engineering File)
User GroupHealthcare Professionals (HCP)
Procedure ReferenceGP-025 Usability and Human Factors Engineering
Standard ReferenceIEC 62366-1:2015 §5.9 - Summative Evaluation
Related DocumentsR-TF-025-006-ITP Summative Evaluation Questionnaire (ITP)
User-Specific Questionnaire

This questionnaire is specific to Healthcare Professionals (HCP). A separate questionnaire exists for IT Professionals (R-TF-025-006-ITP Summative Evaluation Questionnaire (ITP)) due to the different knowledge domains required for each user group.


HCP Use Scenario 3: Knowledge Assessment​

Q#QuestionExpected answerOutcomeObservations
Q1

What information is produced by the Legit.Health Plus report?

Top 5 predictions, quantification of disease intensity, extent, or count of clinical signs
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Q2

What is the probability of malignancy for the lesion you analyzed today?

The percentage that the report produces
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Q3

What are the conditions that the Legit.Health Plus have detected?

The conditions that the report produces
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Q4

Can this report output of the Legit.Health Plus act as a diagnosis?

No
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
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R-TF-025-006 Summative Evaluation Questionnaire
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R-TF-025-006-ITP Summative Evaluation Questionnaire (ITP)
  • Document Information
  • HCP Use Scenario 3: Knowledge Assessment
All the information contained in this QMS is confidential. The recipient agrees not to transmit or reproduce the information, neither by himself nor by third parties, through whichever means, without obtaining the prior written permission of Legit.Health (AI Labs Group S.L.)