GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

K233964

Cosmo Artificial Intelligence - AI Ltd · cleared 2024-01-12 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“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. GI Genius is composed of software (namely, ColonPRO™ 4.0) and hardware (namely, GI Genius™ Module 100 and 200).”
Algorithmartificial intelligence-based device; neural network
source quote (p.6)
“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. New software version ColonPRO™ 4.0 has improved detection performance resulting from the retraining of the neural network.”
Adaptive (vs locked)No
source quote (p.7)
“New software version ColonPRO™ 4.0 has improved detection performance resulting from the retraining of the neural network. This is the only software change affecting the detection performance.”
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“SOUP VPN and SSH service configured with certification-based authentication”

Validation studies (2)

Retrospective clinical

n=150 images

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

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

Bench

n=162 other

endpoints: Verification of the revised software at the system level; Validation of the revised software at the user level; Risk mitigation measures identified during Risk Management; Tests according to the Standalone Performance Testing Protocol v2.0

Reported performance (4 observations)

sensitivity88.07
source quote (p.8)
“Lesion-based sensitivity 88.07%”
specificity0.9821
source quote (p.8)
“True negative: 5,248,406 False positive: 95,391”
aurocas written: “auc”0.826
source quote (p.8)
“Frame-Based TPr/FPr ROC curve, AOC 0.826”
sensitivityas written: “True positive rate per frame”60.14
source quote (p.8)
“True positive rate per frame Mean: 60.14%”

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
1
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

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/K233964