ArteraAI Prostate

DEN240068

Artera Inc. · granted 2025-07-31 · product code SFH · Pathology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“ArteraAI Prostate is a software only device intended to analyze scanned histopathology whole slide images (WSIs) from treatment-naïve prostate core needle biopsies prepared from formalin fixed paraffin-embedded (FFPE) tissue and stained using Hematoxylin & Eosin (H&E) stains.”
AlgorithmArtificial Intelligence/Machine Learning (AI/ML) based algorithm using deep learning and self-supervised learning
source quote (p.3)
“ArteraAI Prostate is a software only device that utilizes deep learning algorithms developed with WSI of H&E-stained prostate needle biopsies to assess risk of distant metastasis and prostate cancer specific mortality. The software performs an algorithmic assessment of features extracted from WSIs using self-supervised learning.”
Adaptive (vs locked)No
source quote (p.3)
“The algorithm is locked; it is not a continuous learning (continual machine learning model) algorithm.”
PCCPYes
source quote (p.22)
“The ArteraAI Prostate includes a pre-determined change control plan (PCCP) approved by the US Food and Drug Administration (FDA).”
Cybersecurity addressedYes
source quote (p.8)
“ArteraAI Prostate cybersecurity documentation demonstrated that the device met the cybersecurity requirements as outlined in Section 524B of Federal Food, Drug, and Cosmetic Act (FD&C Act). This includes a threat model, software bill of materials, data security training, validation and mitigation of cybersecurity risks, cyber risk management, labeling, cyber testing, and post market cyber vulnerabilities and other information for safeguarding the algorithms.”

Validation studies (2)

Bench

n=52 patients · 3 site(s)

endpoints: precision; reproducibility

standards: CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures, 3rd Edition

Retrospective clinical

n=886 patients · 3 site(s)

endpoints: 10-year risk of distant metastasis (DM); 10-year risk of prostate cancer specific mortality (PCSM)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.

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 De Novo AI/ML devices in the Pathology 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/DEN240068