The sequencing of the Activities specified in this Profile are shown in Figure 1: Figure 1: Ultrasound Measurement of Shear Wave Speed for Estimation of Liver Fibrosis - Activity Sequence 3.1. Pre-delivery This activity describes calibrations, phantom imaging, performance assessments or validations prior to delivery of equipment to a site (e.g. performed at the factory) that are necessary to reliably meet the Profile Claim. 3.1.1 3.1.2 Parameter Actor Requirement Acoustic MFR output Below FDA acoustic output limits. Output (SWS testing MFR specification and certification. Mode) Phantom MFR QA QIBA pre-specified phantom testing. 95%CI or CV [XX to YY%]. Testing Bias: +-5% of nominal. xx MFR Software version equals version specified in QIBA profile (Manufacturer Software specific section – Appendix D). verification Hardware and MFR transducer Shall ensure the equipment intended for use is listed in Appendix D as a Manufacturer compliant combination of System, Software Revision and Transducer. specified parameters
The sequencing of the Activities specified in this Profile are shown in Figure 1: Figure 1: Ultrasound Measurement of Shear Wave Speed for Estimation of Liver Fibrosis - Activity Sequence 3.1. Pre-delivery This activity describes calibrations, phantom imaging, performance assessments or validations prior to delivery of equipment to a site (e.g. performed at the factory) that are necessary to reliably meet the Profile Claim. 3.1.1 3.1.2 Parameter Actor Requirement Acoustic Output (SWS Mode) MFR output testing Below FDA acoustic output limits. MFR specification and certification. Phantom Testing MFR QA QIBA pre-specified phantom testing. 95%CI or CV [XX to YY%]. Bias: +-5% of nominal. xx Software verification MFR Software version equals version specified in QIBA profile (Manufacturer specific section – Appendix D). Hardware and transducer Manufacturer specified parameters MFR Shall ensure the equipment intended for use is listed in Appendix D as a compliant combination of System, Software Revision and Transducer.
QIBA_Profile_04112016_BSG_Edited_discussed_with_MD4-10-16.docx