Inter-operator Variability Testing - Requirements for

MakingADifference

Starting to get Involved
#1
Hi All.

Is there any requirement to perform inter operator variability testing like you would do under the FDA? I am trying to find some guidance and not having much luck and wondered if this was required or not?

Thanks
James
 
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shimonv

Trusted Information Resource
#2
I don't think there is official regulatory requirement for it. Product requirements, specifications, and risks should indicate which level of V&V to apply.

Shimon
 

DanMann

Starting to get Involved
#3
Could this fall under your requirements for Usability? If the product gets different results for different operators, this would be a risk. What kind of product are you thinking of?
 

yodon

Staff member
Super Moderator
#4
62366 is a harmonized standard for usability. Coupled with what @DanMann and @shimonv mention about risk management, you would definitely consider this.

By the way, what FDA regulation requires inter-operator variability testing?
 

MakingADifference

Starting to get Involved
#5
Thanks for the comment.

This is a software device where there will be operators interpreting images. We have a risk that the software can calculate something incorrectly. The operator is not doing any measurements.
 

yodon

Staff member
Super Moderator
#6
If the operator has to interpret the results, there are clear usability concerns. FDA guidance on HF & UE application notes that a minimum of 15 users (of each class) be included in a study. Depending on where / how it's used, you may well need more. Factors such as age, sex, ethnicity, level of education, etc. might all need to be considered. It will also be something you need to keep close postmarket eyes on!
 
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