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  • Legit.Health Plus Version 1.1.0.0
    • Index of Technical Documentation or Product File
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    • Description and specifications
    • R-TF-001-007 Declaration of conformity
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      • Requirements
        • PRS
        • Deprecated Software Requirement Specification (SRS)
        • Software Requirement Specification (SRS)
          • SRS-001: Generate Automatic PASI (APASI) severity analysis report for single zone
          • SRS-002: Generate Automatic SCORAD (ASCORAD) severity analysis report for single zone
          • SRS-003: Generate Automatic Urticaria Activity Score (AUAS) report for single zone
          • SRS-004: Generate Automatic GPPGA (AGPPGA) report for single zone
          • SRS-005: Generate Automatic IHS4 (AIHS4) report for single zone
          • SRS-006: Generate ALADIN Score report for single zone
          • SRS-007: Generate Automatic VASI (AVASI) report for single zone
          • SRS-008: Generate Automatic AWOSI report for single zone
          • SRS-009: Generate Automatic NSIL report for single zone
          • SRS-010: Generate Automatic SALT (ASALT) report for single zone
          • SRS-011: Generate Automatic EASI (AEASI) report for single zone
          • SRS-012: Orchestrate severity analysis workflow
          • SRS-013 Generate an aggregated ICD probability distribution from image set
          • SRS-014 Generate per-image ICD analysis with explainability heat map
          • SRS-015 Generate an unified report of ICD class distributions
          • SRS-016: Include model sensitivity in report
          • SRS-017: Include model specificity in report
          • SRS-018: Include entropy score in report
          • SRS-019: Include the indicator of having a condition in the report
          • SRS-020: Include the indicator of the image presenting a pigmented lesion in the report
          • SRS-021: Include the indicator of malignancy in the report
          • SRS-022: Include the indicator of needing an urgent referral in the report
          • SRS-023: Include the indicator of needing a high priority referral in the report
          • SRS-024 The product validates the image with the AI LABS's Dermatological Image Quality Assessment (DIQA) algorithm
          • SRS-025 The product validates the image's clinical domain
          • SRS-026 The product classifies the image's modality
          • SRS-027 The product provides a final image validity summary
          • SRS-028: Orchestrate diagnosis support workflow
          • SRS-029: Compute 7-Point Checklist (7PC) Score
          • SRS-030: Compute Dermatology Life Quality Index (DLQI) Score
          • SRS-031: Compute PURE-4 Score
          • SRS-032: Compute Urticaria Control Test (UCT) Score
          • SRS-033: Calculate Global Acne Grading System (GAGS) Score
          • SRS-034: Calculate RESVECH Score
          • SRS-035: Calculate SCOVID Score
          • SRS-036: Calculate Physician's Global Assessment (PGA) Score
          • SRS-037: Generate Global Automatic VASI (AVASI) Score for Full Body
          • SRS-038: Secure Communication Protocol Enforcement
          • SRS-039: Network Service Exposure
          • SRS-040: URL-Based API Versioning
          • SRS-041: Concurrent API Version Support
          • SRS-042: JSON Data Interchange Format
          • SRS-043: Endpoint Implementation
          • SRS-044: Deterministic Response Schemas
          • SRS-045: Performance and Latency
          • SRS-046: Standard HTTP Status Code Usage
          • SRS-047: Endpoint Access Control
          • SRS-048: API Documentation Endpoint
          • SRS-049: High Availability and Load Balancing Support
          • SRS-050: Provision of Client SDKs for Integration
          • SRS-051: API Rate Limiting
          • SRS-052: Request Body Size Limitation
          • SRS-053: Provision of Clinical Parameter Endpoints
          • SRS-054: API Health Check Endpoint
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      • REL-001 Version 1.1.0.0
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  • Legit.Health Plus Version 1.1.0.1
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  • Legit.Health Plus Version 1.1.0.0
  • Design History File
  • Requirements
  • Software Requirement Specification (SRS)
  • SRS-008: Generate Automatic AWOSI report for single zone

SRS-008: Generate Automatic AWOSI report for single zone

Identifier​

SRS-008

Software System​

  • Processor
  • Report Builder
  • Orchestrator

Category​

  • Functional

Description​

Upon a user-initiated request to perform a severity analysis on an ingested wound image, the system shall execute the Automatic Wound Severity Assessment Index (AWOSI) assessment. The system shall perform the following integrated actions:

  1. Calculate clinical signs and assessments: Invoke the AWOSI model to analyze the image and compute the following:
    • The quantitative value for erythema.
    • The characteristics of the wound borders (e.g., Damaged, Delimited, Thickened).
    • The state of the perilesional skin (e.g., Erythema, Maceration).
    • The presence of biofilm-compatible tissue.
    • The type of exudation (e.g., Fibrinous, Purulent, Serous).
    • The different tissue types in the wound bed (e.g., Slough, Necrotic, Granulation).
    • The percentage contribution of each tissue type to the total wound area.
  2. Compute AWOSI score and its corresponding interpretation using the calculated clinical scores.
  3. Generate visual evidence: Create a composite derivative image by overlaying multiple, color-coded segmentation masks on the original input image. These masks shall delineate the overall wound area and the specific locations of different tissue types (e.g., slough, granulation, necrosis) within the wound bed.
  4. Assemble and present report: Generate and display a structured clinical report that consolidates the analysis results. The report shall contain the following clearly labelled data points:
    • The final AWOSI score and its corresponding interpretation (e.g., "Stage 4").
    • A list of all assessed wound characteristics from step 1.
    • The quantitative breakdown of tissue contributions.
    • The composite visual evidence image generated in step 2.

Derived from PRS​

  • PRS-002: Measure severity by combining image analysis and user-reported symptoms in scoring systems
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SRS-009: Generate Automatic NSIL report for single zone
  • Identifier
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  • Derived from PRS
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.)