Allix5

DEN240047

Clairity, Inc. · granted 2025-05-30 · product code SEZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.2)
“Allix5 is a Software as a Medical Device (SaMD)”
Algorithmcomputer vision-based deep learning model
source quote (p.3)
“Allix5's risk prediction algorithm was developed using a computer vision-based deep learning model that was trained on screening mammograms across diverse patient populations.”
Adaptive (vs locked)No
source quote (p.15)
“A post-market device monitoring plan was provided to ensure that changes to the hardware and/or software of the compatible mammography systems will be monitored and any changes that could impact Allix5's performance will be identified. Additionally, to ensure Allix5's consistent performance across diverse clinical environments, the post-market device monitoring plan was designed to monitor site-specific statistics that may be potential causes of changes in performance or outputs indicating drift. Data will be collected through ongoing, active systematic collection, and monitoring will include analysis and interpretation of data.”
PCCPYes
source quote (p.18)
“The device manufacturer must develop and implement a post-market performance management plan that ensures regular assessment of the generalizability and device performance in the intended patient population in real-world use.”
Cybersecurity addressedYes
source quote (p.5)
“Allix5 cybersecurity documentation demonstrates that the device meets all 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 adversarial examples, cyber risk management, labeling, cyber testing, and post market cyber vulnerabilities and other information for safeguarding the algorithms.”

Validation studies (1)

Retrospective clinical

n=44,112 patients · 5 site(s)

endpoints: Clinically acceptable discrimination of Allix5 in the total study population as measured by the area under the time-dependent, cumulative-dynamic receiver operating characteristic (ROC) curve (AUC); Clinically acceptable calibration of Allix5 in the total study population as evaluated by the Greenwood-Nam-D'Agostino (GND) test

Reported performance (1 observation)

aurocas written: “auc”0.7CI [0.69, 0.72]
source quote (p.10)
“AUC(5) [95% CIs] 0.70 [0.69, 0.72]”

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 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/DEN240047