Genius Digital Diagnostics System with the Genius Cervical AI algorithm
DEN210035Hologic Inc. · granted 2024-01-31 · product code QYV · Pathology
Premarket evidence — what FDA accepted
source quote (p.2)
“The Genius Digital Diagnostics System with the Genius Cervical AI algorithm includes the Genius Digital Imager, Genius Image Management Server (IMS), the Genius Review Station, and the Genius Cervical AI algorithm.”
source quote (p.5)
“The Genius Cervical AI algorithm uses Convolutional Neural Network (CNN) technology to analyze ThinPrep® Pap Test whole slide images scanned using the Genius Digital Imager and selects OOIs to be displayed for review by a CT or PT.”
source quote (p.9)
“The Genius Cervical AI algorithm v1.0.16.0 will remain locked for use with the authorized device and will not be continually trained and improved with each cohort analyzed in clinical practice, after marketing authorization.”
source quote (p.9)
“Cybersecurity: The cybersecurity documentation is consistent with the recommendations for information that should be included in premarket submissions outlined in the FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices: Guidance for Industry and Food and Drug Administration Staff" (issued October 2, 2014).”
Validation studies (3)
Reader study (MRMC)
n=1,994 cases · 4 site(s)
endpoints: sensitivity; specificity
standards: EN ISO 14971:2019 Medical Devices - Application of risk management to medical devices, EN 61010-1:3rd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General Requirements, IEC 61010-1:3rd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General Requirements, CSA C22.2 #61010-1-12:3rd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General Requirements, EN 61010-2-101:2nd Edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for IVD medical equipment, IEC 61010-2-101:2nd Edition Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101: Particular requirements for IVD medical equipment, CSA C22.2 # 61010-2-101:2nd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for IVD medical equipment, IEC 60601-1-2:4th Edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests, IEC TR 62366-2 Medical Devices-Part 2: Guidance on the application of usability engineering to medical devices, EN 60601-1-2:4th edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances -Requirements and tests, EN 61326-2-6:2nd edition Electrical equipment for measurement, control and laboratory use-EMC requirements-Part 2-6 Particular requirements-IVD medical equipment, IEC 61326-2-6:2nd Edition Electrical equipment for measurement, control and laboratory use-EMC requirements-Part 2-6 Particular requirements-IVD medical equipment, IEC 61326-1:2nd edition Electrical equipment for measurement, control and laboratory use EMC requirements – Part 1: General requirements, EN 61326-1:2nd edition Electrical equipment for measurement, control and laboratory use EMC requirements – Part 1: General requirements, EN ISO 13485:2016 Medical Devices - Quality management systems-requirements for regulatory purposes, EN 13612:2002 Performance evaluation of IVD medical devices, ASTM D4169-16:2016 Standard Practice for Performance Testing of Shipping Containers and Systems, EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labeling) Part 1: Terms, definitions and general requirements, EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labeling) Part 3: In vitro instruments for professional use, EN 62304:2015 Medical Device Software - Software life cycle processes, EN 62366-1:2015 Medical Devices - Application of usability engineering to medical devices, ISO 15223-1:2016 Medical devices- symbols to be used with medical device labels, labelling and information to be supplied-Part 1 General requirements, FDA Guidance: 2016 Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, FDA Guidance: May 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, FDA Guidance September 2019 Guidance for Off-the-Shelf Software Use in Medical Devices, FDA Guidance: February 2016 Applying Human Factors and Usability Engineering to Medical Devices
Bench
n=37 cases · 1 site(s)
endpoints: accuracy; reproducibility; agreement rates
standards: EN ISO 14971:2019 Medical Devices - Application of risk management to medical devices, EN 61010-1:3rd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General Requirements, IEC 61010-1:3rd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General Requirements, CSA C22.2 #61010-1-12:3rd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General Requirements, EN 61010-2-101:2nd Edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for IVD medical equipment, IEC 61010-2-101:2nd Edition Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101: Particular requirements for IVD medical equipment, CSA C22.2 # 61010-2-101:2nd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for IVD medical equipment, IEC 60601-1-2:4th Edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests, IEC TR 62366-2 Medical Devices-Part 2: Guidance on the application of usability engineering to medical devices, EN 60601-1-2:4th edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances -Requirements and tests, EN 61326-2-6:2nd edition Electrical equipment for measurement, control and laboratory use-EMC requirements-Part 2-6 Particular requirements-IVD medical equipment, IEC 61326-2-6:2nd Edition Electrical equipment for measurement, control and laboratory use-EMC requirements-Part 2-6 Particular requirements-IVD medical equipment, IEC 61326-1:2nd edition Electrical equipment for measurement, control and laboratory use EMC requirements – Part 1: General requirements, EN 61326-1:2nd edition Electrical equipment for measurement, control and laboratory use EMC requirements – Part 1: General requirements, EN ISO 13485:2016 Medical Devices - Quality management systems-requirements for regulatory purposes, EN 13612:2002 Performance evaluation of IVD medical devices, ASTM D4169-16:2016 Standard Practice for Performance Testing of Shipping Containers and Systems, EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labeling) Part 1: Terms, definitions and general requirements, EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labeling) Part 3: In vitro instruments for professional use, EN 62304:2015 Medical Device Software - Software life cycle processes, EN 62366-1:2015 Medical Devices - Application of usability engineering to medical devices, ISO 15223-1:2016 Medical devices- symbols to be used with medical device labels, labelling and information to be supplied-Part 1 General requirements, FDA Guidance: 2016 Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, FDA Guidance: May 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, FDA Guidance September 2019 Guidance for Off-the-Shelf Software Use in Medical Devices, FDA Guidance: February 2016 Applying Human Factors and Usability Engineering to Medical Devices
Bench
n=50 cases
endpoints: cell count accuracy; within-imager reproducibility; between-imager reproducibility
standards: EN ISO 14971:2019 Medical Devices - Application of risk management to medical devices, EN 61010-1:3rd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General Requirements, IEC 61010-1:3rd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General Requirements, CSA C22.2 #61010-1-12:3rd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 1: General Requirements, EN 61010-2-101:2nd Edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for IVD medical equipment, IEC 61010-2-101:2nd Edition Safety requirements for electrical equipment for measurement, control and laboratory use Part 2-101: Particular requirements for IVD medical equipment, CSA C22.2 # 61010-2-101:2nd edition Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101: Particular requirements for IVD medical equipment, IEC 60601-1-2:4th Edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests, IEC TR 62366-2 Medical Devices-Part 2: Guidance on the application of usability engineering to medical devices, EN 60601-1-2:4th edition Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances -Requirements and tests, EN 61326-2-6:2nd edition Electrical equipment for measurement, control and laboratory use-EMC requirements-Part 2-6 Particular requirements-IVD medical equipment, IEC 61326-2-6:2nd Edition Electrical equipment for measurement, control and laboratory use-EMC requirements-Part 2-6 Particular requirements-IVD medical equipment, IEC 61326-1:2nd edition Electrical equipment for measurement, control and laboratory use EMC requirements – Part 1: General requirements, EN 61326-1:2nd edition Electrical equipment for measurement, control and laboratory use EMC requirements – Part 1: General requirements, EN ISO 13485:2016 Medical Devices - Quality management systems-requirements for regulatory purposes, EN 13612:2002 Performance evaluation of IVD medical devices, ASTM D4169-16:2016 Standard Practice for Performance Testing of Shipping Containers and Systems, EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labeling) Part 1: Terms, definitions and general requirements, EN ISO 18113-3:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labeling) Part 3: In vitro instruments for professional use, EN 62304:2015 Medical Device Software - Software life cycle processes, EN 62366-1:2015 Medical Devices - Application of usability engineering to medical devices, ISO 15223-1:2016 Medical devices- symbols to be used with medical device labels, labelling and information to be supplied-Part 1 General requirements, FDA Guidance: 2016 Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices, FDA Guidance: May 2005 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, FDA Guidance September 2019 Guidance for Off-the-Shelf Software Use in Medical Devices, FDA Guidance: February 2016 Applying Human Factors and Usability Engineering to Medical Devices
Reported performance (2 observations)
source quote (p.21)
“91.7 [1950/2127] (90.1, 93.3)”
source quote (p.21)
“91.0 [3414/3753] (89.7, 92.1)”
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 Pathology 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.