Clinical Data to Prove Equivalence

C

CPLLC

#1
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
 
Elsmar Forum Sponsor
M

MIREGMGR

#3
I think your goal may be (1) to prove equivalence to the old model, and (2) to prove safety and effectiveness.

Maybe proving (1) also proves (2), but I'd think the FDA would want (2) proved from first principles unless it was self-evident.

The test process you propose may prove (1), but a better understanding of what the device does and what the data means is necessary to accept that supposition.

I don't see how it would prove (2).
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
without knowing what the device does, I would have to say that recrunching the data would not generally be acceptable to the FDA if it were the sole test. Typically, one should run actual patient trials to ensure that the two devices are not substantially different (the statisticians at the FDA may croak if you say prove "equivalence")
 
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