Section 11: Performance evaluation Please provide the necessary performance evaluation report to support the safe use of the device following this change. These data should arise from studies in a clinical or other 1. appropriate environment or result from relevant biological references. This should include the following: Performance Data including claims should be supported by a reference measurement system and should contain Yes No information on Reference Methods used Yes No 2. Reference Materials used Yes No The known Reference values Yes No Accuracy and measurements Yes No
Section 11: Performance evaluation 1. Please provide the necessary performance evaluation report to support the safe use of the device following this change. These data should arise from studies in a clinical or other appropriate environment or result from relevant biological references. This should include the following: 2. Performance Data including claims should be supported by a reference measurement system and should contain information on Yes No Reference Methods used Yes No Reference Materials used Yes No The known Reference values Yes No Accuracy and measurements Yes No
GRF-25-53a.docx