See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

K240697

See-Mode Technologies Pte. Ltd. · cleared 2024-09-09 · product code QDQ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“See-Mode Augmented Reporting Tool, Thyroid (SMART-T) is a stand-alone reporting software to assist trained medical professionals in analyzing thyroid ultrasound images of adult (>=22 years old) patients who have been referred for an ultrasound examination.”
Algorithmmachine learning algorithms
source quote (p.6)
“The software analyzes thyroid ultrasound images and uses machine learning algorithms to extract specific information.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Standalone

n=600 cases

Reader study (MRMC)

n=600 patients

endpoints: readers' localization and characterisation of thyroid nodules

Reported performance (7 observations)

aurocas written: “auc”0.703CI (0.642, 0.762)
source quote (p.16)
“IOU > 0.5 Standalone (95% CI) 0.703 (0.642, 0.762)”
accuracyas written: “Localisation Accuracy”0.951
source quote (p.17)
“Localisation Accuracy Standalone (95% CI) 95.1%”
accuracyas written: “Composition Accuracy”0.867
source quote (p.17)
“Composition Standalone (95% CI) 86.7%”
accuracyas written: “Echogenicity Accuracy”0.682
source quote (p.17)
“Echogenicity Standalone (95% CI) 68.2%”
accuracyas written: “Shape Accuracy”0.934
source quote (p.17)
“Shape Standalone (95% CI) 93.4%”
accuracyas written: “Margin Accuracy”0.584
source quote (p.17)
“Margin Standalone (95% CI) 58.4%”
accuracyas written: “Echogenic Foci Accuracy”0.703
source quote (p.17)
“Echogenic Foci Standalone (95% CI) 70.3%”

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/K240697