CINA-ASPECTS

K233342

Avicenna.AI · cleared 2024-03-15 · product code POK · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“CINA-ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data.”

Algorithmartificial intelligence algorithm, machine learning algorithms based on deep learning techniques, AI/Deep Learning

source quote (p.9)

“CINA-ASPECTS uses machine learning algorithms based on deep learning techniques.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (3)

Bench

sample size not stated

standards: NEMA PS 3.1 - 3.20

Retrospective clinical

n=200 cases · 5 site(s)

endpoints: generalize to a range of typical patient demographics, Clinical parameters, ASPECTS regions, and image acquisition parameters

Reader study (MRMC)

n=200 cases

endpoints: assessment of ASPECTS; improving reader accuracy

Reported performance (1 observation)

aurocas written: “auc”0.79

source quote (p.8)

“In addition, the overall readers' ROC AUC also improved significantly from 0.75 (Unaided arm) to 0.79 (Aided arm).”

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).