Re: earlier Q about "breakthrough", there is some blurb in one...

Re: earlier Q about "breakthrough", there is some blurb in one of the Appendices of the meddev2.7 device guideline that explains basis for "breakthrough" under CE, largely for unmet need. In which case regulator will accept much greater uncertainty about a product.
Agree with your "solid if unspectacular" description for OSL trial data. I picked up this interesting plot from one of the papers you cited in an earlier post (Ruarus; thanks for posting) where the authors have plotted survival results from trials for various devices and stereotactic RT in LA pancreatic ca. Bit scattered as would be expected. PANCO 16 month median survival result puts it in that crowded bunch towards the left of the plot, and Panco trial had big advantage of using much better chemotherapy which wasn't around when many of these trials ran. So not the best results, but also not the worst.