A.I diagnostic software is considered as medical device in FDA?

Brian K

Starting to get Involved
#1
Hello,

I have noticed that 510(k) A.I devices as below

Siemens.jpg

I think diagnostic softwares(Prostate Mr, Brain Mr) seem A.I analytic algorithm and they are operating as a module under image managing software(Engine).
I know that software alone is considered as medical device(SaMD) in FDA but I wonder A.I algorithm is also considered as a medical device.

My view is
A.I algorithm can't operate alone. It must be operating with image managing software.
Then it should be considered as component of image managing software.

Does A.I algorithm diagnostic software alone is considered as medical device?
 
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Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#2
Does this platform (AI) diagnose, detect, monitor, or suggest treatment or actions related to a health condition?
 

Brian K

Starting to get Involved
#3
Does this platform (AI) diagnose, detect, monitor, or suggest treatment or actions related to a health condition?
Normally, the platform detect, monitor the patient image. When it contains additional software(A.I diagnostic algorithm), it provides diagnose function. Kind of plug-in concept.
So my question was, A.I diagnostic algorithm is considered as medical device itself
 

yodon

Staff member
Super Moderator
#4
A.I algorithm can't operate alone.
Agreed. And based on that statement alone, the algorithm cannot be a medical device (software). As @Ed Panek points out, it has to have a medical purpose.

It must be operating with image managing software.
This, I think, is not totally accurate. Obviously there has to be input but it wouldn't have to be from image managing software.

Think of it like a database. You have a database back-end engine (e.g., SQL). The engine does nothing until an application is put on top of it. So you have to have a system that performs a medical purpose.
 

Brian K

Starting to get Involved
#5
Agreed. And based on that statement alone, the algorithm cannot be a medical device (software). As @Ed Panek points out, it has to have a medical purpose.



This, I think, is not totally accurate. Obviously there has to be input but it wouldn't have to be from image managing software.

Think of it like a database. You have a database back-end engine (e.g., SQL). The engine does nothing until an application is put on top of it. So you have to have a system that performs a medical purpose.

Then, you mean the devices captured in my question seem that they can perform a medical purpose not restricted to database right ?
 
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