Avenda Health AI Prostate Cancer Planning Software

K221624

Avenda Health, Inc. · cleared 2022-11-22 · product code POK · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“The Avenda Health AI Prostate Cancer Planning Software is an artificial intelligence (AI)-based decision support software”
AlgorithmMachine learning-based algorithm based on patient information and image morphological, intensity, and geometric characteristics.
source quote (p.13)
“Machine learning-based algorithm based on patient information and image morphological, intensity, and geometric characteristics.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

n=50 patients

endpoints: accuracy in contouring GGG 2 lesions

Reader study (MRMC)

sample size not stated

endpoints: superior sensitivity; superior specificity; measures of balanced accuracy; clinical quality; complete csPCa encapsulation rate

Reported performance (3 observations)

sensitivity97.4
source quote (p.7)
“The study results demonstrated that lesion contours produced using the Proposed Device had superior sensitivity (mean 97.4% vs 38.2%, p < 0.0001) compared to SOC contours”
specificity72.1
source quote (p.7)
“and superior specificity compared to hemi-gland contours (mean 72.1% vs 53.4%, p < 0.0001).”
accuracyas written: “balanced accuracy”84.7
source quote (p.7)
“lesion contours produced using the Proposed Device were superior to both SOC and hemi-gland contours using measures of balanced accuracy (mean 84.7% vs 67.2% & 75.9% respectively, p < 0.0001)”

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/K221624