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        • R-TF-025-004 Summative evaluation protocol
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        • 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)
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  • R-TF-025-006 Summative Evaluation Questionnaire
  • R-TF-025-006-ITP Summative Evaluation Questionnaire (ITP)

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

Document Information​

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

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


ITP Use Scenario 2: Knowledge Assessment​

Q#QuestionExpected answerOutcomeObservations
Q1

What is the correct endpoint URL for authentication?

/login
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Q2

What endpoint should you use to send an image for diagnosis support?

/diagnosis-support
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Q3

How should you store the JSON response from the API?

Store without modification, ensuring no data loss or corruption, and can retrieve it for further processing
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Q4

What fields should you verify in the /diagnosis-support response according to the IFU?

All expected fields as documented in the IFU, including predictions, confidence scores, and metadata
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Q5

How do you verify the API version you are integrating with?

Check the response headers from /internal/status endpoint and verify against documentation
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
Q6

What should you do when the API returns a 400 or 500 error?

Handle and log the error correctly according to IFU procedures (e.g., retry or user alert)
  • OK (Success)
  • UD (Use difficulty)
  • CC (Close call)
  • UE (Use error)
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  • Document Information
  • ITP Use Scenario 2: 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.)