Strain AI (SAI001)

K242359

Exo Inc · cleared 2024-11-20 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Exo's Strain Al is a software as a medical device (SaMD), intended as an aid in diagnostic analysis of echocardiography data.”

AlgorithmDeep Convolutional Neural Networks for Segmentation or Landmark Detection

source quote (p.7)

“Deep Convolutional Neural Networks for Segmentation or Landmark Detection”

Adaptive (vs locked)No

source quote (p.6)

“non-adaptive machine learning algorithms”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: Intraclass Correlation Coefficient (ICC); Root Mean Square Difference (RMSD)

standards: IEC 62304:2006/AC:2015, FDA's 'Content of Premarket Submissions for Device Software Functions' Guidance, FDA Guidance 'Technical performance assessment of quantitative imaging in radiological device premarket submissions'

Reported performance (1 observation)

agreement_kappaas written: “ICC”0.95CI 0.91 – 0.97

source quote (p.8)

“0.95 (0.91 – 0.97)”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).