Vent Creativity Knee v1.0 (Hermes)
K241961Vent 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 addressedFDA source did not state this
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). 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).