GI Genius

K211951

Cosmo Artificial Intelligence - AI Ltd · cleared 2021-07-23 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology. The device includes hardware to support interfacing with video endoscopy systems.”
Algorithmartificial intelligence-based device, neural network
source quote (p.5)
“GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps, including those with flat (non-polypoid) morphology. The software design change includes an upgrade to the inference engine to optimize algorithm speed and improve energy efficiency, together with a retraining of the neural network with additional procedure videos, and improved data augmentation, to improve polyp detection capability robustness.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

standards: IEC 60601-1, IEC 60601-1-2

Standalone

n=150 images

endpoints: Lesion-based sensitivity; Frame level performance (True positive, True negative, False positive, False negative); True positive rate per frame; False positive rate per frame; Frame-Based TPr/FPr ROC curve, AOC; False positive clusters per patient

Reported performance (3 observations)

sensitivity0.865
source quote (p.7)
“Lesion-based sensitivity 86.5%”
aurocas written: “auc”0.796
source quote (p.7)
“Frame-Based TPr/FPr ROC curve, AOC 0.796”
sensitivityas written: “True positive rate per frame”0.583
source quote (p.7)
“Mean: 58.30%”

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
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
3
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K241887 (decision 2024-07-25) from Cosmo Artificial Intelligence - AI Ltd for a matching device line ("GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K241887

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K233964 (decision 2024-01-12) from Cosmo Artificial Intelligence - AI Ltd for a matching device line ("GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K233964

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K231143 (decision 2023-05-19) from Cosmo Artificial Intelligence - AI Ltd for a matching device line ("GI Genius System 100 and GI Genius System 200") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K231143

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 Gastroenterology-Urology 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/K211951