C
Hello everyone,
This is the first time I have ever done this, so please excuse my clumsiness with the process...
A company is improving its device and wants to prove equivalence to the older model for safety and effectiveness. The manufacture has hundreds of data files generated from patients who have used the predicate device and these same data files are able to be run through the new device to obtain the same results. Is this an acceptable way of proving the new device is substantially equivalent to the old device? If so, how many records should be used in the population for the test? Are there any other rules or issues to be aware of?
Thank you all for your assistance,
CPLLC
This is the first time I have ever done this, so please excuse my clumsiness with the process...
A company is improving its device and wants to prove equivalence to the older model for safety and effectiveness. The manufacture has hundreds of data files generated from patients who have used the predicate device and these same data files are able to be run through the new device to obtain the same results. Is this an acceptable way of proving the new device is substantially equivalent to the old device? If so, how many records should be used in the population for the test? Are there any other rules or issues to be aware of?
Thank you all for your assistance,
CPLLC