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)

K241887

Cosmo Artificial Intelligence - AI Ltd · cleared 2024-07-25 · product code QNP · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“GI Genius is composed of software (namely, ColonPRO™ 4.0) and hardware (namely, GI Genius™ Module 100, 200, and 300).”
AlgorithmGI 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. This device with advanced software algorithms brings attention to images to aid in the detection of lesions.
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. This device with advanced software algorithms brings attention to images to aid in the detection of lesions.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

n=40 other

endpoints: Non-inferiority of performance

Retrospective clinical

n=150 images

endpoints: 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)

sensitivity0.8807
source quote (p.9)
“Lesion-based sensitivity 88.07%”
aurocas written: “auc”0.826
source quote (p.9)
“Frame-Based TPr/FPr ROC curve, AOC 0.826”
sensitivityas written: “True positive rate per frame”0.6014
source quote (p.9)
“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
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 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/K241887