What is considered a "core algorithm"? (From an FDA guidance document)

SSchoepel

Involved In Discussions
#1
The FDA guidance document on when to submit a software change include this definition:
“Core algorithm” changes are modifications made to an algorithm that directly impact or contribute to the device’s intended use. Examples include: alarm algorithms on a monitor, a motor control algorithm for an infusion pump, and a detection module and measurement engine algorithm for an IVD.

Internally there is some back and forth on what constitutes an algorithm in the product. So I'm coming here for regulatory opinion.

Our device is a PACS (picture archiving and communications system) that is use by radiology for displaying scans to look for lesions suspicious of cancer, segment those lesions (draw the contours of it in 2D and display and calculate information about it as a 3D object), and provide data used for diagnoses and treatment. The radiologist draws what is thought to be the longest axis of the lesion and our device finds the contours and builds the 3D structure of the lesion across the scan "slices." Some people refer to the code that finds the extent of the lesion in 2D and 3D as our algorithm. Sometimes it's even referred to as our core algorithm (but without knowledge of the definition above).

Our intended use statement includes this sentence: The product automatically and semi-automatically segments normal structures and abnormal structures (for example, nodules and lesions), and provides metrics for the structures. (And in our last submission we defined the code/algorithm that does this activity.)

Others look at the FDA definition and say that's only for "black box" type of code like artificial intelligence software (both static AI and AI that modulates based on input).

Does anyone have experience internally or with the FDA when they have defined what they consider to be a core algorithm?
 
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yodon

Staff member
Super Moderator
#2
Presume you're referring to the guidance for Deciding When to Submit a 510(k) for a Software Change to an Existing Device?

I don't believe that guidance is limited to AI / machine learning by any means (see the Discussion Paper for current thinking on that topic). The example cited for core algorithm change clearly indicates it's for any software application:

Examples include: alarm algorithms on a monitor, a motor control algorithm for an infusion pump, and a detection module and measurement engine algorithm for an IVD.
 

pziemlewicz

Involved In Discussions
#3
In short, if you were to change the way your system created 3D from 2D, that would be a change to your core algorithm. There may be others.

I've done work with CT scanners and may be able to provide additional insight if you want to PM a specific question.
 

SSchoepel

Involved In Discussions
#4
Presume you're referring to the guidance for Deciding When to Submit a 510(k) for a Software Change to an Existing Device?

I don't believe that guidance is limited to AI / machine learning by any means (see the Discussion Paper for current thinking on that topic). The example cited for core algorithm change clearly indicates it's for any software application:

Examples include: alarm algorithms on a monitor, a motor control algorithm for an infusion pump, and a detection module and measurement engine algorithm for an IVD.
Yes, that's the one I'm referencing. And thank you, I did not think it was limited to the AI/machine learning parts of a product.

I'm fairly certain the guidance document came out a few years before the discussion paper. Do you have any idea the date of release of the discussion paper? It's not listed.
 

yodon

Staff member
Super Moderator
#5
I think the discussion paper was pretty recent. The page with the link above says the content is current as of 1/28/2020 - that may well have been when it was posted.
 
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