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QMS
  • Welcome to your QMS
  • Quality Manual
  • Procedures
  • Records
  • Legit.Health Plus Version 1.1.0.0
    • Index of Technical Documentation or Product File
    • Summary of Technical Documentation (STED)
    • Description and specifications
    • R-TF-001-007 Declaration of conformity
    • GSPR
    • Clinical
    • Cybersecurity
    • Design and development
    • Design History File
    • IFU and label
    • Post-Market Surveillance
    • Quality control
    • Risk Management
    • Usability and Human Factors Engineering
      • 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
      • T-TF-025-005 Summative evaluation observation form
      • T-TF-025-006 Summative evaluation questionnaire
      • T-TF-025-007 Summative evaluation report
  • Legit.Health Plus Version 1.1.0.1
  • Licenses and accreditations
  • Applicable Standards and Regulations
  • Public tenders
  • Legit.Health Plus Version 1.1.0.0
  • Usability and Human Factors Engineering
  • T-TF-025-006 Summative evaluation questionnaire

T-TF-025-006 Summative evaluation questionnaire

HCP Use Scenario 3: Knowledge Assessment​

tip

Correct answers are bolded.

Q#QuestionResponse
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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T-TF-025-005 Summative evaluation observation form
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T-TF-025-007 Summative evaluation report
  • 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.)