So, specifically, one of the barriers to utilization of robots is the time it takes for the robot to actually do the cutting. So, we believe that our changes could enhance the fee rates of the system, and we’ve proven that to be the case in kind of our testing. Dr. Unis was here actually last week for a lab, and he can speak more to that. But there are some improvements. So, I don’t want folks to think that we’re just purely modifying the system so we don’t have to do a 510(k) — not a 510(k) clinical trial. There are actually ways that we think this will make our device even more attractive to surgeons. So, I just want to kind of help explain where we are. Now, this is — might be a little bit tedious, but I think it’s really important. So, Monogram is kind of where — not that it’s a little bit small in production, should have made a little bigger, but Monogram’s kind of — it says Monogram is here and it’s circled design verification phase.
So, we are in the thick of the design verification phase. So, there’s approximately 60 hardware and system test protocols that we’re working through and then another over 100 software test protocols we’re working through. And these are all tests to basically prove that the system is safe. The goal is to be largely complete, I say largely, and that’s bolded complete with the verification and validation, what we said is in the first half of this year. So, we’re pushing very aggressively on that. We’re making very good headway. Is it possible for it to that time line to slip? Yes, certainly. And I’ll get into what would make it slip. The biggest risk really is that we’re a pretty small team and working very hard. And most of this is in our control, but there are some of it that’s not, I’ll get into that.
And then we are in parallel preparing the 510(k). So, our quality and regulatory team is working very hard to have kind of everything ready, so that once we finish the verification and validation testing, we would be able to submit that to the FDA as quickly as possible. So, our target that we’ve said publicly is for a submission in the second half of 2024. And what we’ve said is we believe we have the capital on hand for that submission. And the reason I corrected Noel is the — right now the time for the FDA to respond is on the order of between five and six months, that’s kind of their turnaround time for clearance or approval or rejection of a 510(k). So, that’s variable. The FDA — that’s out of our hands if the FDA took longer, obviously, we would need to account for that if they took shorter, that’s great.
But this gives you some idea of kind of where we are. So, we — the biggest risk, and I’ll just kind of talk to the verification and validation. So, this is what we have to do before we consume at 510(k), I’m just going to get into some of the big ones. The biggest risk is — and we have Kamran on the phone who’s had many kind of sleepless nights over this is what’s called ISO 6601. So, this is a kind of an industry gold standard for safety. It’s a third-party that basically is kind of certifying the safety of your device. It’s not a requirement for the FDA, but it’s a very, very, very strong and good, nice to have, and we think that it greatly enhances our 510(k) submission to have this. The biggest, most risky part of this that we’ve already passed was radiated and conductive emissions.
So, we pushed very hard through that. The team — I can’t say you had many sleepless nights getting through that, but the pace at which we cleared that was phenomenal and so we’re halfway through that. And we expect that that’s going to be done. And the next piece of it, we have more confidence in. We’ve been able to derisk the remaining piece with internal testing. The radiated and conducted emissions is very hard to simulate in house, but the remaining tests we’ve already tested, we’re pretty confident our system is good. There’s a huge amount of paperwork involved, but we are pushing really hard on that. But that is a risk if that — that’s a third-party and a steady or slow, there’s not much we can do about it. But we do think we’re on track there.
We’re pushing them very hard. The other thing is just kind of resource constraints. We have a lean team. We’ve been running it very lean, and that’s always a risk if you have key people get sick that hurts us, but I think we’re in a good spot. We — human factors, which is part of the verification requires a minimum of 15 patient surgeons. Surgeons are very busy. We have identified the surgeons for the most part that we’re going to be working with, and we’re getting them booked in on aggressive schedules, but it’s tough. Surgeons have very busy schedules and sometimes things don’t work out. We think we have plenty of cushion there, but I do want to flag it as a risk. And then again, this is what we’ve said. These aren’t guarantees. We think we have a pretty good shot at it and we’re pushing to do it as aggressively as possible.
And of course, we think that it’s a very meaningful milestone for the company to submit a 510(k) with what we think are very, very strong equivalence arguments and what we think is a very, very attractive safety profile to the FDA. So, to — we’re not just going in with risk of that. We want to mitigate risk every possible way. So, what we’re doing in parallel, as I said, is we are preparing to launch a clinical trial outside of the U.S. This is well underway. So, we expect, hopefully, we can make some more announcements in the near future about this. But we are currently targeting about — we need to do just to make the statistics work out about 88 surgeries at three sites, and we have — we’re looking for a 25% safety event rate reduction.