<div dir="ltr">Greetings Group members.<div><br></div><div>This is a reminder that the submission deadline time for comments to the FDA document is on 3/24.</div><div><br></div><div><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions" target="_blank">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions</a><br></div><div><br></div><div>Unless there is an interest by the group members to submit any text in a group, I will submit the text I send below next weekend and mention our new published paper.</div><div><br></div><div>Hopefully others will choose to submit comments.</div><div><br></div><div> Jacob</div><div><br></div><div><br></div></div><br><div class="gmail_quote"><div dir="ltr" class="gmail_attr">On Sun, Feb 6, 2022 at 5:36 PM Jacob Barhak <<a href="mailto:jacob.barhak@gmail.com">jacob.barhak@gmail.com</a>> wrote:<br></div><blockquote class="gmail_quote" style="margin:0px 0px 0px 0.8ex;border-left:1px solid rgb(204,204,204);padding-left:1ex"><div dir="auto"><div>Greetings group members,<div dir="auto"><br></div><div dir="auto">Hopefully this thread caught your attention and you plan to submit feedback to the FDA.</div><div dir="auto">Here is the FDA link again:</div><div dir="auto"><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions" target="_blank">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions</a><br></div><div dir="auto"><br></div><div dir="auto">I do hope we hold a discussion to generate more impactful ideas.</div><div dir="auto"><br></div><div dir="auto">Regardless, I plan to submit a response based on the text I sent and our paper in mid March.</div><div dir="auto"><br></div><div dir="auto">I do hope many of you will read the document and then their thoughts to this mailing list as well.</div><div dir="auto"><br></div><div dir="auto"> Jacob</div><div dir="auto"><br></div><br><br><div class="gmail_quote"><div dir="ltr" class="gmail_attr">On Sun, Jan 30, 2022, 11:51 Jacob Barhak <<a href="mailto:jacob.barhak@gmail.com" target="_blank">jacob.barhak@gmail.com</a>> wrote:<br></div><blockquote class="gmail_quote" style="margin:0px 0px 0px 0.8ex;border-left:1px solid rgb(204,204,204);padding-left:1ex"><div dir="ltr">Greetings group members,<div><br></div><div>The purpose of this email is to start a discussion on the FDA draft: Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.</div><div><br></div><div>I went back to the paper draft and looked at it. The draft does a good job on focusing on procedures and steps to assess credibility. Especially important is the work flw suggested. From those perspectives it's a good document that may help others in the future.</div><div><br></div><div>One basic idea that we also discussed in the paper was the "question of interest" - Early on John Rice introduced this concept into our paper and others supported it later. However, even in our paper there were different opinions on how to approach credibility and reuse models defined for different questions in mind. The design process may start from a different question than the one that we wish to satisfy. Since this document is a draft from a regulatory body, it is less about the design process and more about compliance. However, our discussion in the paper may be still relevant since it introduced the concept of comparison among models. </div><div><br></div><div>I looked through the draft and could not see an element of relativity , or in other words, a reference to compare to. And this concept may be important in the future since the modeling field evolves quickly, especially with regards to machine learning techniques that evolve rapidly. A model that seems credible today and passes some tests may not be very good in a few years. Also one model may not perform as good as a combination of models. Yet this model, although outdated may outperform human decision - therefore I believe there should be 2 elements considered by the FDA that include a reference / relative performance. </div><div><br></div><div>1. Group of models - how does a model perform compared to existing models with regards to satisfying the question of interest. Models will eventually become outdated and although models may be sufficient to answer a question, within time some models may not be as good as others. And this time period may be relatively short. So the regulator has to consider outdated models and not only set a threshold for compliance. So to keep compliance over time a model has to outperform existing models. This idea can be extended to allow models to cooperate in an ensemble, yet the first step is benchmark models taking into account other models as a relative reference.</div><div><br></div><div>2. Relative to human practice - the model also has to be compared with current human standards without the model. A device with a model may not be accurate, yet human accuracy may be even worse without that model to aid. Moreover, humans may not agree with the same evidence produced. To give an example, please look at this paper: <a href="https://arxiv.org/abs/1806.02121" rel="noreferrer" target="_blank">https://arxiv.org/abs/1806.02121</a> . In this paper the authors test their model against humans and show that humans test to agree with their model more than they agree with each other. So the FDA should keep in mind that humans that are certified may not perform well and the lower threshold for compliance should take this into consideration. </div><div><br></div><div>I am writing those ideas in hope this will start a discussion where we can formulate and combine answers by group members and submit them together. Otherwise I will submit a version of this text myself. </div><div><br></div><div>I hope there will be interest in providing this feedback.</div><div><br></div><div> Jacob</div><div><br></div><div><br></div></div><br><div class="gmail_quote"><div dir="ltr" class="gmail_attr">On Thu, Jan 27, 2022 at 9:37 PM Jacob Barhak <<a href="mailto:jacob.barhak@gmail.com" rel="noreferrer" target="_blank">jacob.barhak@gmail.com</a>> wrote:<br></div><blockquote class="gmail_quote" style="margin:0px 0px 0px 0.8ex;border-left:1px solid rgb(204,204,204);padding-left:1ex"><div dir="ltr">Greetings reproducibility and integration groups,<div><br></div><div>John Rice has sent this message. about the FDA document:</div><div><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions" rel="noreferrer" target="_blank">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions</a><br></div><div><br></div><div>And indeed this is relevant to our work - in fact this was my suggestion for the next activity. </div><div><br></div><div>FDA has released a request for comments for a document drafted. We actually referred to this document in our paper. </div><div><br></div><div>I was planning to start a discussion on this paper so we can submit responses, either individually or as a group or sub-groups after we finish with the paper.</div><div><br></div><div>Yet since the paper is almost done and time is running short, it is perhaps a good idea to discuss this now.</div><div><br></div><div>Looking forward to your feedback.</div><div><br></div><div> Jacob</div><div><br></div><div><img src="https://links.govdelivery.com/track?enid=ZWFzPTEmYnVsbGV0aW5yZWNpcGllbnRpZD0xMjU3MjEzOTE2MzctbCZzdWJzY3JpYmVyaWQ9MTI1NjEwMzAxMiZtc2lkPSZhdWlkPSZtYWlsaW5naWQ9MjAyMjAxMjcuNTI0NDUyNjEmbWVzc2FnZWlkPU1EQi1QUkQtQlVMLTIwMjIwMTI3LjUyNDQ1MjYxJmRhdGFiYXNlaWQ9MTAwMSZ0eXBlPW9wZW4mc2VyaWFsPTE3MDUxNDUyJmVtYWlsaWQ9am9obi5yaWNlQG5vYm94ZXMub3JnJnVzZXJpZD1qb2huLnJpY2VAbm9ib3hlcy5vcmcmdGFyZ2V0aWQ9JmZsPSZtdmlkPSZleHRyYT0mJiY=" width="1" height="1" alt="" style="border-width: 0px; border-style: hidden;"><br></div></div>
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