In the clinical trial of the domestic registration certificate of the fat transfer device, it is usually necessary to evaluate the sensitivity and specificity of the product. These two indicators are key factors in evaluating the performance and effectiveness of medical devices.
Sensitivity:
Definition: Sensitivity refers to the ability of a test to correctly identify a patient in a population who actually has a disease. It indicates the ability of the test method to detect real patients.
Calculation formula: Sensitivity = number of true positives (number of true positives + number of false negatives).
Requirements: High sensitivity means that the product is able to effectively detect patients with genuine diseases, reducing the risk of missed diagnoses.
Specificity:
Definition: Specificity refers to the ability of a test to correctly rule out people who do not have a disease in a person who does not actually have the disease. It indicates the ability of the test method to identify non-patients.
Formula: Specificity = number of true negatives (number of true negatives + number of false positives).
Requirements: High specificity means that the product is effective in excluding individuals who do not have the disease, reducing the risk of misdiagnosis.
When designing and performing clinical trials of the domestic registration certificate of the fat transfer device, it is necessary to ensure that the sensitivity and specificity of the assessment meet the requirements of the NMPA. Specific requirements may vary depending on the purpose and nature of the product. In the design of the trial protocol, it is necessary to reasonably select the study population, test method, and ensure sufficient sample size to ensure accurate assessment of sensitivity and specificity.
Communication with the NMPA is also critical to ensure that the design of trials and evaluation methods comply with their regulations. In addition, ensure that the actual assessment results are fully stated in the trial report and that the necessary data support is provided to support the application for obtaining a registration certificate.