V&V phase: Justification of acceptance criteria (statistical method ) - (Medical Device)

#1
Hello !

I am working in a medical device start-up (developping an invasive device) and we are currently finishing our specification phase and drafting our V&V master plan, to define the necessary tests to proove our specifications are well achieved.
We are struggling with one our test, and more specifically with its associated criteria and I hope someone here could help us with this!

One of our specification is "the temperature raising of the medical device does not lead to safety issue".
As there is no published article/study regarding the impact on our environment (temperature level vs. the defined part of body), we don't have a specific temperature limit that can be justified with litterature (and as we are the first to develop this device, we also don't have any concurent to compare with!).
The management does not want us to define a critieria based on our R&D testing, meaning that we can't use a nominal value/targeted temperature value as a criteria.

So for now we have the following strategy:
We'd show that the temperature does not lead to safety issue by performing these two tests :
- Preclinical study on animals : criterion are linked to histological results
- Temperature repetability testing : to show all our devices reach more or less the same temperature in order to give credit to our preclinical study

My questions are the following :
1) Can we just use the criteria "the temperature range of all tested devices is +/-2°C" without giving any further justification ? I'm not at ease with that at all but other point of view would be helpfull...
2) Is there any statistic method that could make a "link" between the number of tested devices and the results obtained to show the temperature is repeatable enough, but without nominal value to refer to ?
I thought of the "UTL=Mean+k*s" but the criteria is usually related to a predetermined specification limit like UTL=Mean+k*s<=USL
And sadly here, we are asked not to use an USL ...

I hope it's clear enough!
Thank you in advance for your feedback !

Mhal2
 
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#2
In these situations, it is normal to perform characterization studies to gain the knowledge needed to define a specification.
Product specifications must have engineering level of detail and must have a clear pass/fail criterion unless it is absolutely not possible to do so. It seems to me that it would be fairly easy for you to define a specification. You could even do some testing using a meat product from the grocery store or just use general information like what is the proper temperature for a baby's bathwater. Also, there has to be information regarding heat effect on tissue in the literature somewhere.

It is not clear to me how the repeatability would be related to safety. I think for safety you would be concerned only with the temperature values over time. Your spec should be something like, "Device temperature shall be less than or equal to xx degrees over xxx period of use."

Also, you need to know what "safety issue" you are trying to prevent. This is where your risk analysis comes in.
 
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