Clinical Evidence Requirement of Software as a Medical Device (SaMD) - - PowerPoint PPT Presentation

Clinical Evidence Requirement of “Software as a Medical Device” (SaMD)

Dr David Hau Senior Medical Officer, Clinical Section, Medical Devices Branch Innovate Health Conference 27 June 2019

Essential Principle 14

Clinical evidence Every medical device requires clinical evidence, appropriate for the use and classification of the device, demonstrating that the device complies with the applicable provisions of the Essential Principles. From the Therapeutic Goods (Medical Devices) Regulations 2002 – Schedule 1, Part 2

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The essential principles

Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 1

General principles 1. Use of medical devices not to compromise health and safety 2. Design and construction of medical devices to conform to safety principles 3. Medical devices to be suitable for intended purpose 4. Long-term safety 5. Medical devices not to be adversely affected by transport or storage 6. Benefits of medical devices to

• utweigh any side effects

Principles about design and construction 7. Chemical, physical and biological properties 8. Infection and microbial contamination 9. Construction and environment properties

• 10. Medical devices with a measuring function
• 11. Protection against radiation
• 12. Medical devices connected to or equipped

with an energy source

• 13. Information to be provided with medical

devices

• 14. Clinical evidence
• 15. Principles applying to IVD medical devices
• nly

www.legislation.gov.au

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Level of clinical evidence should be commensurate with intended use

• Significance of the information provided by the SaMD to the healthcare

decision

• Seriousness of the healthcare situation or condition
• Do the target population include any vulnerable group (e.g. children, at-risk

adults)?

• If intended for use by lay users, what level of support from healthcare

professionals is intended?

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What is clinical evidence for a medical device?

Clinical evidence guidelines: Medical devices

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What is clinical evidence for a software medical device?

www.imdrf.org

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Clinical Evidence

Clinical Evaluation ① Valid Clinical Association ② Analytical Validation ③ Clinical Validation Is there a valid clinical association between your SaMD output and your SaMD’s targeted clinical condition? Does your SaMD correctly process input data to generate accurate, reliable, and precise

• utput data?

Does use of your SaMD’s accurate, reliable, and precise

• utput data achieve your intended

purpose in your target population in the context of clinical care?

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Clinical Evidence

• Alignment of clinical content with current clinical guidance and best practices

for the target population

• Accurate and reliable output
• Accuracy, reproducibility with test data representative of intended use
• Performance for clinical use in indicated patient population
• Useability study
• Real-world / ongoing data showing clinical outcomes
• Clinical study data demonstrating effectiveness for intended use
• Observational study or Intervention study, preferably with control group

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Equivalence

• Equivalence for conventional medical devices is based on:
• Clinical characteristics
• Technical characteristics
• Biological characteristics
• Equivalence for SaMDs should include at least the following considerations:
• Intended use
• Algorithm
• Useability

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Further considerations

• Initial setup – oversight by healthcare

professional, with continued review

• Healthcare or technology literacy required of

the user

• User training

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