EchoGo Amyloidosis (1.0)

K240860

Ultromics Limited · cleared 2024-11-15 · product code SDJ · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.7)
“Both subject and primary predicate devices are software-only devices and automated machine learning-based decision support system, indicated for patients undergoing routine cardiovascular assessment using echocardiography.”
AlgorithmAI algorithm developed using a convolutional neural network
source quote (p.6)
“The binary classification decision is derived from an AI algorithm developed using a convolutional neural network that was pre-trained on a large dataset of cases and controls.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.15)
“Cybersecurity and data security testing were conducted to verify that data and patient protected health information security measures are included in the design of the software.”

Validation studies (1)

Retrospective clinical

n=1,164 patients · 15 site(s)

endpoints: sensitivity; specificity; PPV; NPV

standards: ISO 14971:2019, IEC 62304:2015, IEC 62366-1:2020, NEMA PS 3.1 - 3.20 2022d, IEC ISO 10918-1:1994, ISO 14155:2020

Reported performance (6 observations)

sensitivity84.5CI 80.3%, 88.5%
source quote (p.17)
“This equates to a sensitivity of 84.5% (95% CI: 80.3%, 88.5%)”
specificity89.7CI 87.0%, 92.4%
source quote (p.17)
“a specificity of 89.7% (95% CI: 87.0%, 92.4%)”
ppvas written: “Positive Predictive Value at 2.2% prevalence”15.6CI 11.0%, 20.8%
source quote (p.17)
“Positive Predictive Value at 2.2% prevalence* 15.6% (11.0%, 20.8%)”
npvas written: “Negative Predictive Value at 2.2% prevalence”99.6CI 99.5%, 99.7%
source quote (p.17)
“Negative Predictive Value at 2.2% prevalence* 99.6% (99.5%, 99.7%)”
ppvas written: “Positive Predictive Value at 36.7% prevalence”82.7CI 78.8%, 86.5%
source quote (p.17)
“a PPV of 82.7% (95% CI: 78.8%, 86.5%)”
npvas written: “Negative Predictive Value at 36.7% prevalence”90.9CI 88.8%, 93.2%
source quote (p.17)
“NPV of 90.9% (95% CI: 88.8%, 93.2%).”

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 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/K240860