Cleerly ISCHEMIA

K231335

Cleerly, Inc · cleared 2023-09-08 · product code QXZ · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool”
Algorithmautomated machine learning-based decision support tool
source quote (p.3)
“Cleerly ISCHEMIA analysis software is an automated machine learning-based decision support tool”
Adaptive (vs locked)No
source quote (p.5)
“The Cleerly ISCHEMIA algorithm is “locked,” meaning it is not a continuous learning algorithm.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.9)
“As an add-on module to Cleerly Labs, controls over Cybersecurity risks for Cleerly ISCHEMIA are enacted within Cleerly Labs. Cleerly Labs has implemented security features for device and data protection. Cybersecurity requirements, risk analysis, and mitigation was addressed in accordance with FDA guidance, “Content of Premarket Submission for Management of Cybersecurity in Medical Devices."”

Validation studies (2)

Bench

sample size not stated

Retrospective clinical

n=582 patients · 23 site(s)

endpoints: Sensitivity, per-vessel territory; Specificity, per-vessel territory

standards: ISO 14971:2019, FDA guidance, “Content of Premarket Submission for Management of Cybersecurity in Medical Devices."

Reported performance (10 observations)

sensitivity0.759CI 70.7%
source quote (p.7)
“Sensitivity, per-vessel territory 75.9% (167/220) 70.7%”
specificity0.834CI 80.2%
source quote (p.7)
“Specificity, per-vessel territory 83.4% (521/625) 80.2%”
sensitivityas written: “Sensitivity (Pooled US + OUS, per-vessel territory)”0.762CI 71.9%, 80.3%
source quote (p.8)
“Sensitivity 76.2% 71.9%, 80.3% (317/416) 80.3%”
specificityas written: “Specificity (Pooled US + OUS, per-vessel territory)”0.852CI 82.8%, 87.4%
source quote (p.8)
“Specificity 85.2% 82.8%, 87.4% (941/1105) 87.4%”
ppvas written: “PPV (Pooled US + OUS, per-vessel territory)”0.659CI 61.2%, 70.3%
source quote (p.8)
“PPV 65.9% 61.2%, 70.3% (317/481) 70.3%”
npvas written: “NPV (Pooled US + OUS, per-vessel territory)”0.905CI 88.5%, 92.3%
source quote (p.8)
“NPV 90.5% 88.5%, 92.3% (941/1040) 92.3%”
sensitivityas written: “Sensitivity (Pooled US + OUS, per patient territory)”0.866CI 82.1%, 90.1%
source quote (p.9)
“Sensitivity 86.6% 82.1%, 90.1% (246/284) 90.1%”
specificityas written: “Specificity (Pooled US + OUS, per patient territory)”0.698CI 64.4%, 74.7%
source quote (p.9)
“Specificity 69.8% 64.4%, 74.7% (208/298) 74.7%”
ppvas written: “PPV (Pooled US + OUS, per patient territory)”0.732CI 68.2%, 77.7%
source quote (p.9)
“PPV 73.2% 68.2%, 77.7% (246/336) 77.7%”
npvas written: “NPV (Pooled US + OUS, per patient territory)”0.846CI 79.5%, 88.6%
source quote (p.9)
“NPV 84.6% 79.5%, 88.6% (208/246) 88.6%”

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

cat i2026-01-01

CPT 75580 (bare code — descriptor at CMS source) · MPFS rate $886.79

MPFS (physician-office) companion to the FFRct OPPS payment. CY2026 non-facility global payment is $886.79. Both fetched CY2026 manufacturer guides also show the 75580 OPPS rate as ~$877 (APC 5724), lower than the CY2025 ~$1,017 in the sibling row — the OPPS rate changed between years. Descriptor at the CMS/AMA source.

Cleerly 2026 billing guide — 75580 PFS tableHeartFlow reimbursement page (2026 final)

5 payer coverage policies reference this clearance or its codes.

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Cardiovascular 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/K231335