Conducting performance studies for NMPA registration (National Medical Products Administration) of invasive blood pressure monitoring devices in China involves demonstrating the device's accuracy, reliability, and clinical effectiveness through rigorous testing and evaluation. Here’s a structured approach on how to conduct performance studies:

1. Study Design and Planning

1. Define Study Objectives:

   • Clearly outline the specific performance parameters and objectives to be evaluated, such as accuracy of blood pressure measurements, device reliability, and usability in clinical settings.

2. Performance Metrics:

   • Identify and define primary and secondary performance endpoints that will be used to assess the device’s effectiveness. This may include parameters like sensitivity, specificity, mean arterial pressure accuracy, and precision.

2. Protocol Development

1. Study Protocol:

   • Develop a detailed study protocol that outlines the study design, inclusion/exclusion criteria, patient population characteristics, device handling procedures, and data collection methods.

2. Comparator Device or Method:

   • Select appropriate comparator devices or methods against which the device performance will be evaluated. This could include gold standard methods like arterial line catheters or validated non-invasive blood pressure monitors.

3. Participant Recruitment and Informed Consent

1. Participant Selection:

   • Recruit participants based on predefined criteria that represent the intended use population for the device. Ensure diversity in patient demographics to reflect real-world clinical scenarios.

2. Informed Consent:

   • Obtain informed consent from each participant or their legally authorized representative before enrollment. Clearly explain the study procedures, risks, benefits, and participant rights in the consent form.

4. Conducting the Study

1. Device Installation and Training:

   • Ensure proper installation and calibration of the invasive blood pressure monitoring device according to manufacturer instructions and study protocol.
   • Provide training to investigators and site staff on device operation, data collection, and safety protocols.

2. Data Collection and Analysis:

   • Collect data on blood pressure measurements obtained using the device and comparator methods during specified study conditions.
   • Use standardized procedures to minimize variability in data collection and ensure accuracy.

5. Statistical Analysis

1. Data Analysis:
   • Perform statistical analysis to compare the device’s performance against the comparator, including calculations of sensitivity, specificity, accuracy, precision, and other relevant metrics.
   • Use appropriate statistical tests (e.g., paired t-tests, Bland-Altman analysis, correlation coefficients) to assess agreement and correlation between device measurements and reference standards.

6. Reporting and Documentation

1. Study Report:

   • Prepare a comprehensive study report that summarizes the study objectives, methods, participant demographics, data analysis results, and conclusions regarding the device’s performance.
   • Include detailed descriptions of study protocols, statistical analyses, and graphical representations of study findings.

2. Regulatory Submission:

   • Compile all relevant documentation, including the study report, informed consent forms, investigator brochures, and regulatory forms, for submission to the NMPA through a qualified local agent or representative.

7. Post-Study Follow-Up and Monitoring

1. Follow-Up Assessments:
   • Conduct follow-up assessments as per the study protocol to monitor participant outcomes and device performance post-study.
   • Evaluate any long-term implications or safety concerns identified during the performance study.

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