GI Genius

DEN200055

Cosmo Artificial Intelligence - AI, LTD · granted 2021-04-09 · product code QNP · Gastroenterology-Urology

FDA De Novo summary for GI Genius (DEN200055)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies: 2
Cited predicates: 0
Performance observations: 6
Product code: QNP

FDA De Novo source PDF ↗

Premarket evidence — what FDA accepted

Device typehardware with ml

source quote (p.2)

“The GI GENIUS™™ is an artificial intelligence/machine learning (AI/ML) device system comprised of software, hardware, and accessories that is intended for polyp detection during standard white-light colonoscopy.”

Algorithmconvolutional neural network (CNN)

source quote (p.4)

“AI/Detection Module: This module is responsible for identifying potential mucosal lesions. The main component consists of a convoluted neural network. ... This includes the convolutional neural network (CNN) of the AI/ML algorithm.”

Adaptive (vs locked)FDA source did not state this

PCCPNo

Cybersecurity addressedYes

source quote (p.5)

“Regarding the cybersecurity, the documentation included all the recommended information from the FDA guidance document “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.” This includes a threat model, cybersecurity mitigation information, a malware-free shipping plan, an upgrade plan, and other information for safeguarding the algorithms.”

Validation studies (2)

Bench

n=150 cases

endpoints: object-level sensitivity; false positive rate (object-level); receiver operating characteristic (ROC); frame-level True Positive Rate (TPR); frame-level False Positive Rate (FPR)

standards: ANSI/AAMI/IEC 60601-1-2:2014, IEC 60601-1:2005 + A1:2012 (Ed. 3.1)

Prospective clinical

n=263 patients · 3 site(s)

endpoints: Adenoma Detection Rate* (ADR*); Adenomas per Colonoscopy* (APC*); Positive Percent Agreement (PPA); Adenoma Detection Rate (ADR); Adenomas per Colonoscopy (APC); Polyps per Colonoscopy (PPC); Polyp Detection Rate (PDR); Serrated Lesions per Colonoscopy (SLPC); Serrated Lesions Detection Rate (SLDR); Advanced Adenoma Detection Rate (aADR); Small Adenoma Detection Rate (sADR); Flat Adenoma Detection Rate (fADR); Proximal Adenoma Detection Rate (pADR); False Positive Rate (FPR)

Reported performance (6 observations)

sensitivity0.8196CI [77.35%; 85.97%]

source quote (p.10)

“Sensitivity > 0 ms: 81.96% [77.35%; 85.97%]”

aurocas written: “auc”0.787CI [0.755-0.817]

source quote (p.14)

“AUC=0.787 [95% C.I.:0.755-0.817]”

detection_rateas written: “Adenoma Detection Rate* (ADR*) (GI Genius)”0.551CI [44.0; 65.8]

source quote (p.19)

“Adenoma Detection Rate (ADR*) (adjusted estimate, %) [95% C.I.] GI Genius (136 subjects): 55.1 [44.0; 65.8]”

detection_rateas written: “Adenoma Detection Rate* (ADR*) (Standard Colonoscopy)”0.42CI [31.3; 53.4]

source quote (p.19)

“Adenoma Detection Rate (ADR*) (adjusted estimate, %) [95% C.I.] Standard colonoscopy (127 subjects): 42.0 [31.3; 53.4]”

agreement_kappaas written: “Positive Percent Agreement (PPA) (GI Genius)”0.621CI [43.4; 77.8]

source quote (p.21)

“Positive Percent Agreement (PPA) (%) [95% C.I.] GI Genius: 62.1 [43.4; 77.8]”

agreement_kappaas written: “Positive Percent Agreement (PPA) (Standard Colonoscopy)”0.652CI [46.0; 80.4]

source quote (p.21)

“Positive Percent Agreement (PPA) (%) [95% C.I.] Standard Colonoscopy: 65.2 [46.0; 80.4]”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: De Novo decision summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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 2026-07-22 · 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 2026-07-22 · 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 2026-07-22 · k_number:K231143
re_clearance
The FDA AI/ML device list shows a newer 510(k) K211951 (decision 2021-07-23) from Cosmo Artificial Intelligence - AI Ltd for a matching device line ("GI Genius") — a new clearance for the same line is a change event.
first seen 2026-07-22 · k_number:K211951

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 2026-09-02.

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 De Novo 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.

Final guidance2021-10
De Novo Classification Process (Evaluation of Automatic Class III Designation)
De Novo pathway
Final (Oct 2021), issued with the De Novo final rule. Most relevant to first-of-a-kind devices without a predicate (DEN-numbered clearances).
Final guidance2026-01
Clinical Decision Support Software
Clinical decision support · SaMD (general)
New final guidance issued Jan 2026, superseding the Sept 2022 version; narrows the device-CDS scope. Applies to software that informs clinical management.
Final guidance2026-01
General Wellness: Policy for Low Risk Devices
SaMD (general) · Clinical decision support
Revised final (Jan 2026); now addresses noninvasive products estimating physiologic parameters (SpO2, BP, glucose). Reshapes the device / non-device line for AI wellness features.
Final guidance2025-09
Computer Software Assurance for Production and Quality Management System Software
SaMD (general) · Postmarket
Final (Sept 2025). Covers software used in production/QMS (incl. ML development-pipeline tooling), superseding Section 6 of the 2002 GPSV — not device software functions themselves.
Final guidance2025-06
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
Cybersecurity · Software premarket content
Reissued June 2025 (retitled 'Quality Management System', was Sept 2023 'Quality System'); adds coverage of FD&C Act §524B cyber devices.
Final guidance2024-12
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Predetermined Change Control Plan · AI/ML lifecycle · Software premarket content
Final (Dec 2024). Supersedes the April 2023 AI/ML PCCP draft.
Final guidance2023-10
Electronic Submission Template for Medical Device 510(k) Submissions
Software premarket content
eSTAR has been mandatory for 510(k)s since Oct 2023 — operationally unavoidable, though not AI-specific.
Final guidance2023-08
Off-The-Shelf Software Use in Medical Devices
Software premarket content · SaMD (general)
Final (Aug 2023). Applies when a device incorporates off-the-shelf software components (common in ML stacks).
Final guidance2023-06
Content of Premarket Submissions for Device Software Functions
Software premarket content · SaMD (general)
Final (June 2023); replaced the May 2005 'Software Contained in Medical Devices' guidance. Documentation level drives the software content of the submission.
Final guidance2022-09
Policy for Device Software Functions and Mobile Medical Applications
SaMD (general) · Clinical decision support
Current version Sept 2022. Frames which software functions FDA regulates as devices.
Final guidance2016-12
Postmarket Management of Cybersecurity in Medical Devices
Cybersecurity · Postmarket
Final guidance2002-01
General Principles of Software Validation
SaMD (general) · Software premarket content
Still active except Section 6 (superseded Sept 2025 by the Computer Software Assurance final guidance).
Draft guidance2025-01
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
AI/ML lifecycle · Software premarket content · Transparency
Draft as of July 2026 (published Jan 2025); finalization is on CDRH's FY2026 agenda but not yet published. Treat as FDA's stated direction, not a binding expectation.
Draft guidance2024-08
Predetermined Change Control Plans for Medical Devices
Predetermined Change Control Plan · Postmarket
Draft (Aug 2024) extending PCCPs beyond AI to all devices under FD&C §515C; not final as of July 2026.
Guiding principles2024-06
Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles
Transparency · AI/ML lifecycle
Guiding principles2023-10
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
Predetermined Change Control Plan · AI/ML lifecycle
FDA/Health Canada/MHRA joint principles (Oct 2023); companion to the GMLP and Transparency principles.
Guiding principles2021-10
Good Machine Learning Practice for Medical Device Development: Guiding Principles
AI/ML lifecycle · SaMD (general)
FDA/Health Canada/MHRA joint principles (Oct 2021). Foundational, not a binding guidance; IMDRF issued a related GMLP document Jan 2025.

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.

Related FDA clearances

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

SKOUT system

K253664

Iterative Health

cleared 2025-12-22

MAGENTIQ-COLO (ME-APDS)

K252178

Magentiq Eye, Ltd.

cleared 2025-10-03

CADDIE

K252586

Odin Medical Limited

cleared 2025-09-12

SKOUT system

K251126

Iterative Health

cleared 2025-05-09

MAGENTIQ-COLO (ME-APDS)

K244023

Magentiq Eye LTD

cleared 2025-01-24

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

CADDIE

K240044

Odin Medical Limited

cleared 2024-07-24

SKOUT® system

K241508

Iterative Scopes, Inc.

cleared 2024-07-03

FDA De Novo summary for GI Genius (DEN200055)

Premarket evidence — what FDA accepted

Validation studies (2)

Reported performance (6 observations)

Predicate network

Postmarket — what happened after clearance

Reimbursement — how devices like this got paid

Applicable FDA guidance — what the submission is measured against

Related FDA clearances

More AI/ML devices under product code QNP

SKOUT system

MAGENTIQ-COLO (ME-APDS)

CADDIE

SKOUT system

MAGENTIQ-COLO (ME-APDS)

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)

CADDIE

SKOUT® system

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)