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Clinical Decision Support Software Question

#1
Hello everyone,

I am looking for some guidance on how to interpret criterion (1) of the FDA's Clinical Decision (CDS) Support Software.

The criterion is as follows:
"Software that is not intended to acquire, process, or analyze a medical image or a signal from an IVDD or a pattern/signal from a signal acquisition system."

If a software uses an algorithm to compare peak amplitude and latency values that are pre-acquired and pre-analyzed by an EEG assessment (using regulated EEG hardware and software) to a normative database of peak amplitude and latency values and generates scores in percentiles that are then used to graph the results in the output report, would this software functionality meet criterion (1)? Why or why not?

Again, would the fact that the algorithm takes the EEG data, compares it to a normative database and spits out percentiles scores mean that the algorithm is processes / analyzing that data? From a software perspective, I could see how this would be interpreted as processing or analyzing the data, but from a clinical perspective the data is not really being analyzed... it is simply a different way of displaying that comparison.

If anyone can help that would be very greatly appreciated. Additionally, if any further context is needed to provide insight let me know.

Thanks!
 
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JeantheBigone

Quite Involved in Discussions
#2
It depends on how you interpret "process" or "analyze" I guess. Is comparing "analyzing?" Is spitting out "processing?" Is it creating any information that did not previously exist?

On another note, is it taking the values and showing them on a pre-existing graph template? Maybe?
 

Tidge

Trusted Information Resource
#3
If anyone can help that would be very greatly appreciated. Additionally, if any further context is needed to provide insight let me know.
I will try to offer my perspective. When I think about the difference between direct diagnosis and monitoring, I recall a (circa 2012) European recommendation to define a device as providing direct diagnosis when it either announces the specific diagnosis or if the information provided by the device is the decisive information for the diagnosis. I believe the FDA is somewhat aligned with this interpretation, but there will be shades that ought to be explored. For example, displaying a 'raw scan' of a mammogram may be one thing, but automatic application of colored shading specifically to indicate tissue that must be removed would likely step over the line (in the absence of a specific and widely accepted standard of diagnosis and treatment).

In the case of your specific application: IF the 'normative database' is publicly available (i.e. from some published source) and the scoring mechanism is described in your material, then I don't think this by itself would lead your software into the diagnostic area.

An example that I think might be similar: If a ME devices software collected repeating waveforms over some period of time and then presented a Fast Fourier Transform decomposition of component sinusoids, I don't think this would be diagnostic because it would be applying a commonly accepted algorithm (as long as the algorithm was disclosed). The medical professionals are assumed to be able to use the information, as presented, to aid in the making of decisions in care and treatment.
 
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