GI Genius
DEN200055Cosmo Artificial Intelligence - AI, LTD · granted 2021-04-09 · product code QNP · Gastroenterology-Urology
Premarket evidence — what FDA accepted
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.”
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.”
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)
source quote (p.10)
“Sensitivity > 0 ms: 81.96% [77.35%; 85.97%]”
source quote (p.14)
“AUC=0.787 [95% C.I.:0.755-0.817]”
source quote (p.19)
“Adenoma Detection Rate (ADR*) (adjusted estimate, %) [95% C.I.] GI Genius (136 subjects): 55.1 [44.0; 65.8]”
source quote (p.19)
“Adenoma Detection Rate (ADR*) (adjusted estimate, %) [95% C.I.] Standard colonoscopy (127 subjects): 42.0 [31.3; 53.4]”
source quote (p.21)
“Positive Percent Agreement (PPA) (%) [95% C.I.] GI Genius: 62.1 [43.4; 77.8]”
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
Not yet tracked — the weekly postmarket refresh hasn't snapshotted this device.
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 guidance2021-10De 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 guidance2026-01Clinical 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 guidance2026-01General 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 guidance2025-09Computer 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 guidance2025-06Cybersecurity 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 guidance2024-12Marketing 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 guidance2023-10Electronic 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 guidance2023-08Off-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 guidance2023-06Content 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 guidance2022-09Policy 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 guidance2016-12Postmarket Management of Cybersecurity in Medical Devices
Cybersecurity · Postmarket
- Final guidance2002-01General 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 guidance2025-01Artificial 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 guidance2024-08Predetermined 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 principles2024-06Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles
Transparency · AI/ML lifecycle
- Guiding principles2023-10Predetermined 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 principles2021-10Good 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.