One important aspect of MDR clinical evaluation is the inclusion of Expected Performance Rates for safety and performance outcomes. These threshold values serve as benchmarks for evaluating the device’s safety and performance. In this blog post, we will explore deficiencies related to threshold values in CEPs and discuss how they can be addressed.
Deficiency #1: Lack of Clear Specification of Threshold Values
One common deficiency observed in CEPs is the absence of clear specification of threshold values for performance and safety outcome parameters. Without these values, it becomes challenging to determine whether the device meets the desired standards.
Response: To address this deficiency, it is essential to revise the CEP and include a detailed specification of threshold values for performance and safety outcome parameters. These values should be based on the State-of-the-Art (SOTA) and reflect the acceptable threshold for the subject device to meet. It is also important to note that threshold values must not be a range of values, as it introduces ambiguity.
Deficiency #2: Inconsistency between CEP and Clinical Evaluation Report (CER)
Another deficiency often observed is the inconsistency between the threshold values specified in the CEP and the analysis presented in the Clinical Evaluation Report (CER). This inconsistency can lead to confusion and undermine the credibility of the evaluation process. This can arise from lack of careful planning in identifying and presenting the relevant and applicable safety and performance outcomes, which leads to difficult situations where inconsistency in available outcome measures in the state of the art literature and the clinical data available for the subject device.
Response: To address this deficiency, it is crucial to ensure that the threshold values specified in the CEP align with the analysis presented in the CER. The CEP and CER should be harmonized to ensure consistent evaluation of the device’s safety and performance. By maintaining consistency, reviewers will have confidence in the evaluation process and its outcomes. This requires careful planning to ensure that the available clinical data for the state of the art align with those of the subject device so that proper benchmarking can be done.
Deficiency #3: Lack of Rationalization for Deviations from Threshold Values
In some cases, deficiencies arise when deviations from the specified threshold values occur without proper rationalization. These deviations may impact the assessment of the device’s safety and performance.
Response: To rectify this deficiency, it is important to provide a rationalization for any deviations from the specified threshold values. The CEP should include a clear explanation of why these deviations are considered acceptable and how they do not compromise the device’s safety and performance. This requires careful examination of demographic information of the clinical data and the quality of the clinical study conducted. Often times, a lower level of evidence (LOE) study or a heterogeneous patient population can lead to unexpected clinical outcomes. By providing a rationalization, reviewers can understand the reasoning behind the deviations and assess their impact on the benefit-risk ratio.
Conclusion: Addressing deficiencies related to threshold values is crucial for ensuring successful clinical evaluation. By specifying clear threshold values, maintaining consistency between the CEP and CER, and providing rationalization for deviations, the evaluation process becomes more robust and effective. Ultimately, these improvements contribute to better decision-making and the delivery of safe and effective medical devices to patients.
*Disclaimer: Please note that the information provided in this blog post is based on the given context and past experience and may not apply to your specific situation as each audit and submission is unique.