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      • Version 1.1.0.0
        • Requirements
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          • PLAN-001 Users submit their credentials to receive an access token
          • PLAN_002 Token expiration in user authentication process
          • PLAN_003 Account lockout for user authentication
          • PLAN_004 Enforcing HTTPS protocol for API communications
          • PLAN_005 Valid SSL/TLS certificates
          • PLAN_006 Rate limiting for anonymous users
          • PLAN_007 Rate limiting for authenticated users
          • PLAN_008 Logging and monitoring of rate limit violations
          • PLAN_009 Validation of request and response data against FHIR schemas
          • PLAN_010 Base64 encoded images are accepted
          • PLAN_011 Non-Base64 encoded images are rejected
          • PLAN_012 Diagnosis support endpoint accepts multiple images
          • PLAN_013 Improved accuracy with multiple images
          • PLAN_014: Password hashing during user registration
          • PLAN_015: Password hash comparison during login
          • PLAN_016: Registration of a new user by authorized individuals
          • PLAN_017 Specification of body zone for scoring systems requiring zone factor
          • PLAN_018 The device's API maintains an uptime of at least 99% over a one-month period
          • PLAN_019 API penetration testing with Intruder.io
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  • Design History File (DHF)
  • Version 1.1.0.0
  • Test plans
  • PLAN_013 Improved accuracy with multiple images

PLAN_013 Improved accuracy with multiple images

Description​

This test verifies that the preliminary diagnosis report generated by analyzing multiple images demonstrates improved accuracy over single-image analysis.

System requirements​

This test can be executed with standard hardware, and it is not necessary to use any specific software. Any commonly available system should be sufficient for the task.

Preconditions​

  • The entire system (including the reverse proxy, REST API, and all upstream services) is deployed, operational, and accessible online.

Input data​

Steps​

Expected outcome​

Verifies software requirements​

  • SWR-007

Risk control for​

    1. Incorrect diagnosis or follow up
    1. Incorrect results shown to patient
    1. Sensitivity to image variability
    1. Lack of efficacy or clinical utility

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:

  • Tester: JD-017, JD-009, JD-004
  • Approver: JD-005
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PLAN_012 Diagnosis support endpoint accepts multiple images
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PLAN_014: Password hashing during user registration
  • Description
  • System requirements
  • Preconditions
  • Input data
  • Steps
  • Expected outcome
  • Verifies software requirements
  • Risk control for
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.)