StrokeSENS ASPECTS Software Application

K250221

Circle Cardiovascular Imaging Inc. · cleared 2025-07-01 · product code POK · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“StrokeSENS ASPECTS is a stand-alone software device that uses machine learning algorithms to automatically process NCCT (non-contrast computed tomography) brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines.”
Algorithmmachine learning algorithms / artificial intelligence algorithm (Deep Learning)
source quote (p.4)
“StrokeSENS ASPECTS is a stand-alone software device that uses machine learning algorithms to automatically process NCCT (non-contrast computed tomography) brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. Technical Implementation ML/AI (Deep Learning)”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.13)
“StrokeSENS has been developed and tested to meet cybersecurity requirements using design vulnerability Assessments (Threat Models), SBOM's, NVD assessments, and Penetration Testing”

Validation studies (2)

Standalone

n=200 patients

endpoints: AUC-ROC; accuracy; sensitivity; specificity

standards: ISO 13485:2016+A11:2021, IEC 62304:2006+A1:2015, IEC 62366:2015+A1:2020, ISO 14971:2019+A11:2021, NEMA 3.1-3.20 (2021)

Reader study (MRMC)

n=100 patients · 23 site(s)

endpoints: AUC; sensitivity; specificity; overall percentage agreement (accuracy); Fleiss's Kappa value

Reported performance (4 observations)

sensitivity0.706CI [69.2%, 72.1%]
source quote (p.13)
“The analysis demonstrated an AUC-ROC of 90.9% (95% CI = [88.7%, 93.1%]), with a accuracy of 90.6 [89.7%, 91.5%], a sensitivity of 70.6% [69.2%, 72.1%] and a specificity of 93.9% [93.2%, 94.7%].”
specificity0.939CI [93.2%, 94.7%]
source quote (p.13)
“The analysis demonstrated an AUC-ROC of 90.9% (95% CI = [88.7%, 93.1%]), with a accuracy of 90.6 [89.7%, 91.5%], a sensitivity of 70.6% [69.2%, 72.1%] and a specificity of 93.9% [93.2%, 94.7%].”
aurocas written: “auc”0.909CI [88.7%, 93.1%]
source quote (p.13)
“The analysis demonstrated an AUC-ROC of 90.9% (95% CI = [88.7%, 93.1%]), with a accuracy of 90.6 [89.7%, 91.5%], a sensitivity of 70.6% [69.2%, 72.1%] and a specificity of 93.9% [93.2%, 94.7%].”
accuracy0.906CI [89.7%, 91.5%]
source quote (p.13)
“The analysis demonstrated an AUC-ROC of 90.9% (95% CI = [88.7%, 93.1%]), with a accuracy of 90.6 [89.7%, 91.5%], a sensitivity of 70.6% [69.2%, 72.1%] and a specificity of 93.9% [93.2%, 94.7%].”

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

0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250221