To clear things up for yourself and potentially others if they’re confused. That 80% figure you’re referencing is not for blockages, it is for hemorrhages, which we knocked out of the park with 92% sensitivity and 85% specificity, and LVO's, which are far easier to see than regular smaller clots as far as I am aware. It would be interesting to see what our figures are for LVO's if you took them out of the clots category, being easier to see, I would imagine (guessing, but perhaps a radiologist here can chime in) that our LVO figure would be higher than our overall ischaemic figures, if this makes sense?
See Ann from 29 of October, 2024. “1 Relevant previously accepted minimum performance targets by the FDA for devices in the area of l *arge vessel occlusion* stroke and intracerebral *haemorrhage* : 80% sensitivity and specificity.”
I don’t believe there has been any mentions of an accepted minimum performance for blockages besides this mention of LVO, but happy to be corrected. I am fairly certain, however, that non-contrast CT would have lower sensitivity/specificity numbers than us in blockages/ischaemic.
It would be great if we do have any radiologists who can add their thoughts to this, but I understand our figure of 78% is not entirely relevant/out of context with the footnote mentioned of 80% in one of the latest updates.
Cheers and Happy Holidays everyone, looking forward to an exciting 2025 for EMV!
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