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!
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!