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Overview
Innolitics' History Hi! We're the co-founders of Innolitics, Yujan & David.
News
How Far Can a 510(k) Predicate Stretch?
Ask most people what a valid predicate looks like and you get the same checklist: same body region, same modality, same product code. The clearance record says otherwise. One in five AI 510(k)s cites a predicate under a different product code. 85 cleared
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How many cases to power an AUC analysis?
Figure 1. Choose the smallest evaluable sample size that reaches the target pass probability. Split that total by the prespecified class ratio and inflate it for missing or unusable cases before enrollment. The short answer There is no single sample size
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What FDA Reviewers Will Ask About Your Sensitivity/Specificity Sample Size
Figure 1. General workflow for sensitivity and specificity sample size planning. Calculate the condition-positive and condition-negative case targets separately, require both endpoint criteria to pass, and then convert those targets into total enrollment
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Cadence Enters TEMPO: What the Second Participant Suggests About the Pilot's Direction
On August 5, FDA named Cadence the second participant in its TEMPO pilot, for a system called HypertensionOS. When FDA named Dexcom as the first participant on July 22, I wrote about how TEMPO and the CMS ACCESS model are designed to address two problems
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How TEMPO and ACCESS Could Support Wearable Diagnostic AI
I've watched too many device companies do everything right, get FDA-cleared, and then stall out because no one will pay for their device. Evidence and payment are two separate mountains, and most teams don't start on the second one until they've finished
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