Vent Creativity Knee v1.0 (Hermes)

K241961

Vent Creativity · cleared 2025-03-20 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Hermes is intended for use as a software interface and image segmentation system for the transfer of medical imaging information to an output file. It is also intended as preoperative software for diagnostic and surgical planning.”
AlgorithmConvolutional Neural Networks model
source quote (p.6)
“The segmentation aspect is a Convolutional Neural Networks model trained with arthritic CT scans from 120 de-identified patients with varying arthritic states, demographics, and CT machines and centers partnering with surgeon champions.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.6)
“Vent Hermes is a cloud-based python code that allows users to upload the de-identified DICOM files to their encrypted Google Cloud Platform folder (a business agreement certified partner with HIPAA and 21 CFR 11 certifications available).”

Validation studies (1)

Retrospective clinical

sample size not stated

endpoints: segmentation accuracy; Dice Similarity Coefficient (Dice score)

Reported performance (1 observation)

diceas written: “Dice Similarity Coefficient (Dice score)”stated without value
source quote (p.7)
“The study compared the segmentation accuracy of Hermes with two predicate segmentation tools, Synopsys and Mimics, using the Dice Similarity Coefficient (Dice score) as the primary metric.”

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
3
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/K241961