AusculThing ACC

K230823

AusculThing Oy · cleared 2023-07-12 · product code DQD · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The AusculThing ACC software is a decision-support SW for the healthcare provider (the user) in the evaluation of patient heart sounds.”
AlgorithmAI-based algorithm, neural network model
source quote (p.5)
“After recording, the ACC analyzes the recordings in conjunction automatically using an AI -based algorithm, which is trained using a proprietary echocardiogram validated high-quality data database. The Murmur detection algorithm is based on a neural network model that uses heart sounds to detect the presence of pathological heart sounds.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.8)
“No protected health information is stored on the user's devices. User has authentication on the app and the mobile device.”

Validation studies (1)

Retrospective clinical

n=133 patients · 4 site(s)

standards: GCP/ISO14155

Reported performance (3 observations)

sensitivity0.905CI 82.3%-95.1%
source quote (p.10)
“90.5% (82.3%-95.1%)”
specificity0.96CI 86.3%-98.9%
source quote (p.10)
“96.0% (86.3%-98.9%)”
accuracyas written: “Accuracy”0.925CI 86.7%-95.9%
source quote (p.10)
“92.5% (86.7%-95.9%)”

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
1
MAUDE reports in code, 12mo
+200%
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/K230823