Medical device software without user interface

ralf90

Starting to get Involved
#1
Dear all,

Currently I am involved with medical device software which can be considered a PACS plugin. What I mean with this is that the PACS is the non-medical device part, while the plugin modifies an image in such a manner that it is a medical device. The basic principle is that you have an image as input for the plugin and a modified image is output, thats it. There is no user interface. It is just, image in, image out.

Question: would you just rationalise that no usability study is needed?
 
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ECHO

Involved In Discussions
#2
If you can justify in writing that usability testing or human factors testing is not necessary, you can replace it with the justification in your DHF.

However, just because your SaMD doesn't have a traditional GUI, doesn't mean that your device doesn't have UI. For example, how does the user select which image is to be modified? Does your plugin require installation and activation? Can the image be modified in a way that the user can misinterpret the information? Could your device affect the usability of a different device?
 

ralf90

Starting to get Involved
#3
Dear Echo,

That is indeed what I also was thinking of. I can imagine a SaMD being without a GUI, but how you state the presence of a UI I interpret this that there will always be a UI. In that sense usability always needs to be performed. Right?
 
#5
Your module has its own intended purpose and provides a medical function to the image? Now what kind of transformation would that be?
Your usability study or summative evaluation has to cover scenarios that are identified within the Risk Management process.
 
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