Jesus Recio

Docket FDA-2026-N-7874
Supplement to my comment of October 15, 2026 (tracking number mv9-2465-yzny)

To the Digital Health Center of Excellence:

Three corrections to my comment and two additions, after an independent review of it.

1. In point 1, I quoted the AnesTRACE benchmark (arXiv 2609.32740) as saying that model recommendations "do not change subsequent patient states." That wording was mine. The paper says its replay "reveals recorded states without allowing their proposals to alter the clinical trajectory," and that a proposed action "does not alter the trajectory." The point stands. The quotation marks were wrong.

2. In point 1, I wrote that a mechanistic physiology engine "can’t inherit the device’s blind spots." It can have blind spots of its own, and the sentence should have said so. After filing, I checked one open-source engine’s propofol model against the Diprivan label. It produced no apnea where the label reports apnea in 43 percent of adults at induction doses, and it lowered heart rate 39 percent where the label reports little or no change. An engine used for benchmarking should itself be validated against published pharmacology before its results count, and the Agency’s Medical Device Development Tool program, named in Section V.D.2, is a fitting route.

3. In point 2, I referred to "the situation described in footnote 25." That situation, an agentic system whose action sequence controls another medical device, is described in Section VII.B; footnote 25 only cites the guidance behind it. Question 26 and element A.1 are the direct basis for the fault-injection test I proposed.

Addition on throughput. The claim in point 1 that thousands of cases a day are practical rests on my own measurement: Pulse 4.4.0 simulated 330 seconds of a patient in 7.6 seconds on a laptop, about 3,000 twenty-minute cases per processor core per day.

Addition on Question 16. On October 5, 2026, Utah’s Office of Artificial Intelligence Policy announced six independent third-party evaluators for its healthcare AI sandbox, paid directly by the companies they evaluate. That arrangement is the independence problem my first criterion addresses.

Sincerely,

Dr. Jesus Recio, CRNA
Tampa, Florida