Lesson 2 – Systematic Literature Review Course: Selecting Your S&P Criteria and Clinical Claims

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Mastering Safety and Performance Criteria and Claims: Your Essential Guide

We’re excited to share insights on mastering safety and performance criteria for medical devices. These criteria and clinical claims form the backbone of your review strategy, so getting them right the first time is crucial.

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Understanding Safety and Performance Criteria, Benefits, and Claims

Why They Matter

Safety and performance endpoints are pivotal in substantiating your medical device’s capabilities while ensuring its safety. These endpoints are essential for meeting the General Safety and Performance Requirements (GSPRs) required for clinical evaluations.

Performance refers to a device’s ability to achieve its intended purpose, leading to a clinical benefit. Clinical benefit is defined as: “The positive impact of a device on an individual’s health, expressed through meaningful, measurable, patient-relevant outcomes, including those related to diagnosis or public health” (MDR Article 2(53)).

Clinical benefits can be:

• Direct (supported by clinical data)
• Indirect (supported by preclinical or other data)

Benefits must align with regulatory standards like those from the FDA or EU MDR. Defining safety and performance parameters at the start of a literature review ensures direction, enabling a smoother compilation of the Clinical Evaluation Report and compliance with GSPRs.

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The Difference Between Clinical Performance and Technical Performance

Clinical Performance

Refers to a device’s ability to achieve its intended purpose and provide clinical benefits. For example, a spinal implant relieving pain and improving functionality demonstrates clinical performance.

Technical Performance

Pertains to the device’s ability to function according to design specifications, such as dimensions, strength, or MRI safety.

Understanding this distinction is vital for structuring literature reviews and defining robust evaluation metrics.

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Defining Your Benefits and Claims

Claims must balance optimism (marketing) and conservatism (regulatory/clinical) while being supported by preclinical or clinical data. For legacy devices developed before the MDR, literature reviews are invaluable for identifying suitable claims.

Sources for Defining Claims

1. Marketing Materials – Brochures, websites, sales pitches.
2. Instructions for Use (IFU) – Critical claims information.
3. State of the Art (SoTA) – Alternative treatment options and similar devices.
4. Relevant Studies – Performance indicators and substantiating data.

Characteristics of Strong Claims

• Quantifiable: Specific, measurable parameters (e.g., “98% success rate”).
• Verifiable: Testable and backed by data.
• Relevant: Addresses genuine clinical needs.

Examples of Strong Claims:

• “Maintains sterility for 5 years under specified conditions.”
• “Reduces procedure time by 15% compared to conventional methods.”

Weak Claims to Avoid:

• “Easy to use” (too subjective).
• “Revolutionary design” (marketing puffery).

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Addressing the Lack of Direct Performance Metrics

For Simple Devices

Devices like surgical gloves may lack obvious performance criteria. Strategies include:

1. Absence of Issues: Highlight the lack of reported problems.
2. Aggregate Data: Combine multiple sources, such as clinical and preclinical data.

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Device Classification-Specific Considerations

Class I Devices

Safety Claim: “Fused handle to prevent breakage during procedures.”
Performance Claim: “Sterile under standard conditions.”

Class IIa Devices

Focus on usability metrics and standard performance characteristics. Example: “Reduces blood clot formation by 15%.”

Class IIb/III Devices

Require comprehensive data and risk-benefit analysis. Example: “Improves patient recovery rates by 25%.”

Software as a Medical Device (SaMD)

Emphasize accuracy and validation metrics. Example: “95% accuracy in lesion detection.”

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Safety and Performance Criteria and Claims Identification Process

Step-by-Step Checklist

1. Predicate/Equivalent Device Research
   • Review competitor IFUs and vigilance databases.
   • Search FDA’s 510(k) database.
2. Regulatory Requirements Review
   • Analyze FDA and EU MDR standards.
   • Extract mandatory safety and performance parameters.
3. Standards Identification
   • Refer to FDA Recognized Consensus Standards or EU Harmonized Standards.
4. Industry Guidance
   • Review professional organizations’ guidelines.
5. Clinical Literature Review
   • Search for adverse events and clinical performance data.
6. Documentation
   • Create a claims matrix.
   • Develop a testing plan (if applicable).

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Conclusion

Safety and performance criteria, along with clinical claims, are essential for medical device submissions. Defining strong, substantiated claims simplifies the submission process and ensures compliance. Practice identifying claims for various devices to hone this critical skill.

Exercise

Pick a device and define claims based on research. Share your proposed claims and reasoning with peers or experts for feedback.