In vivo joint loads have been measured for a small number of telemetric TKR patients, but in order to assess device performance across the entire patient population, a larger patient cohort is necessary.
Definitions of the metrics used to assess device reliability, including those suggested by recent consensus recommendations [8], are described in detail in Additional file 1 and included the percentage of real-time data, skips in data acquisition, failures to calibrate, sensor failures and CVC failures.
To assess device characteristics associated with false-positive tests, we reviewed test storage conditions at the performance study site and examined expiration dates and manufacturer lot numbers of the tests yielding false-positive results.
Postprocedural imaging aims to assess device position, peridevice residual flow in the LAA, and thrombus formation on the device.
We assessed device placement, use during treatment, associated clinical outcomes and infusion pump perfomance in the NO16966 trial.
To assess device reliability, we compared the band shape over three separate trials in structures with 0 and 20% glycerol concentrations.
Definitions of the metrics used to assess device reliability, including those suggested by recent consensus recommendations [ 1], are described in Additional file 1.
As such, it is critical to control as many experimental variables as possible, and to measure those that cannot be controlled during ex vivo testing in order to achieve results that realistically assess device performance.
We also assessed device specific administration rules such as sufficient number of breaths in case of using a spacer, air-tight fit of mask/mouthpiece, and proper shaking of metered dose inhaler (MDI).
