What is the specificity and sensitivity of the VT/VF detection algorithm?
The LifeVest meets the applicable portions of the AAMI standards for Automatic External Cardioverter Defibrillators “AECDs” (ANSI/AAMI DF2-1989 and AAMI DF39-1/93), which specify that the sensitivity for detecting VF should be greater than 90% and the sensitivity for detecting VT should be greater than 75%. It also meets the AAMI standard for specificity which states that the specificity for AECDs should be greater than 95% (without artifacts). ZOLL Lifecor bench testing demonstrated 100% detection sensitivity for VF and 95% detection sensitivity for treatable VT. Bench testing for specificity of the algorithm was 100%.
