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Technical Performance Assessment of Quantitative Imaging in Radiological Devices

This guidance is applicable to all devices that generate quantitative imaging values across radiological imaging modalities, intended uses, levels of automation, and complexity of algorithms. It provides FDA's recommendations on information, technical performance assessment, and user information that should be included in premarket submissions for radiological devices with quantitative imaging functions.

  1. Define and document the quantitative imaging function, measurand, and use conditions
  2. Determine appropriate reference standards and performance metrics
  3. Characterize performance under defined conditions
  4. Develop comprehensive performance specifications including uncertainty information
  5. Conduct appropriate verification and validation testing based on level of automation
  6. Prepare detailed labeling including:
    • Technical descriptions
    • Performance specifications
    • User instructions
    • Limitations and warnings
  7. Document sources of measurement error and their impact
  8. Ensure performance claims are supported by data
  9. Include appropriate quality control and acceptance protocols
  10. Consider level of automation when determining extent of validation required

Key Considerations

Non-clinical testing

  • Technical performance assessment must demonstrate that specifications correspond to claims and uncertainty
  • Performance testing should consider factors impacting performance (patient characteristics, image acquisition, image processing)
  • Use of phantoms recommended as reference standards when possible
  • Statistical analysis plan and acceptance criteria must be pre-defined
  • More robust validation required for fully automated vs manual/semi-automated functions

Human Factors

  • Description of qualifications and training needed for intended users
  • Level of user interaction needed must be specified
  • Instructions for image acceptance and quality assurance activities

Software

  • Detailed description of algorithm, including inputs/outputs
  • Software platform version and characteristics
  • Level of automation (manual, automatic, semi-automatic)
  • Algorithm training paradigm if applicable
  • Software verification documentation

Labeling

  • Description of measurand and units
  • Algorithm inputs and restrictions
  • Performance specifications including uncertainty information
  • Instructions for quality assurance activities
  • Reference database information if applicable
  • Limitations and warnings

Other considerations

  • JCGM 200:2012: International Vocabulary of Metrology – Basic and General Concepts and Associated Terms (VIM 3rd edition)

Original guidance

  • Technical Performance Assessment of Quantitative Imaging in Radiological Devices
  • HTML / PDF
  • Issue date: 2022-06-16
  • Last changed date: 2022-06-15
  • Status: FINAL
  • Official FDA topics: Medical Devices, Radiation-Emitting Products, Premarket, Radiological Health
  • ReguVirta summary file ID: 42ca7f4b22418d8f742fad9c5d088d74
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