ArteraAI Breast sorted breast cancer patients by risk of spread

In FDA's review of ArteraAI Breast, five-year distant metastasis risk was 8.7% in its high risk group and 0.9% in its low risk group, against 3.6% across 1,271 patients.

  • Not rated an organization

    The study measured how well the risk groups separate later metastasis on archived cases, and no patient's care depended on the software.

Depth runs from 1, a convenience or time saved, to 5, a life or a livelihood preserved.

Status
Intended benefit.
Evidence

foundstudiedreportedclaimed

An independent regulatory document supports the benefit.

Compared with

Five-year distant metastasis risk across all 1,271 patients. Measured.

Without the system
3.6%
With it
8.7% in the high risk group and 0.9% in the low risk group
The system’s part
Not isolated. The study measured how the software's risk groups track later metastasis. It did not compare decisions or outcomes with and without the software.
Limits
Not yet checked.
Costs and harms
Not yet checked.
Later
Not yet checked.

Download data Cite Suggest a correction

Benefit type
Improved Task Accuracy
System
ArteraAI Breast
Made by
Artera, Inc.
Used by
Artera (retrospective clinical validation on archived slides from 1,271 patients at three US sites)
Where
Three sites, United States
Stage
Tested in a laboratory
Date
, when the source was published
Kind
Aggregate result
Broad benefit
Analyzing Data or Information
Collections
Scrutiny and findings
Last revised
31 October 2026

Sources

  1. Regulatory document, by authors with no tie to the system.

    U.S. Food and Drug Administration, Center for Devices and Radiological Health. 510(k) substantial equivalence determination decision summary for ArteraAI Breast (K254115). Cleared 2026-05-04.

    5-year risk of DM for ArteraAI Breast Risk category High (8.7%) is statistically significantly higher than the overall risk (3.6%) and this difference (5.1%) is clinically significant.

Details

AI system

Workflow

Slides from treatment-naive breast resections were stained with H&E and scanned on a Philips Ultra Fast Scanner or a Leica Aperio GT450 DX. Physicians supplied the patient's age, tumor size and nodal status.

Follow-up

Conditions for replication

The patient is an adult with HR+/HER2-, N0 or N1 early-stage invasive breast cancer who is a candidate for adjuvant therapy. A pathologist confirms cancer on the slide and releases the report.

Entry details

Sector

Healthcare.

Purpose

Artera built ArteraAI Breast to give physicians five- and ten-year risks of distant metastasis for prognostic decisions in early breast cancer.

Not yet checked: model, release, provider, role, configuration, inputs and outputs, autonomy, human oversight, AI contribution, beneficiaries, reach, distribution and access, duration, every measurement question, every money question, ownership and control, dependencies, cross-border connections, geopolitical implications, replication attempts, availability, institutional decision, grounds, action and result, success criterion, every evidence question, observed or intended, alternative assessments, related entries, other identifiers, category mappings.

Cite this record

Peter H. Vartanian. (2026). ArteraAI Breast sorted breast cancer patients by risk of spread (AIBD-0799). Artificial Intelligence Benefits Database, edition of 31 October 2026. https://petervartanian.xyz/aibd/records/AIBD-0799.html (archived at https://doi.org/10.7910/DVN/AADSII, version 4.0)

BibTeX Data Field definitions