(28 days)
Not Found
Yes
The device description explicitly states "GI Genius is an artificial intelligence-based device" and mentions "Al-based software".
No
The device is a computer-assisted reading tool that aids in the detection of colonic mucosal lesions; it is not intended to provide therapy or treatment.
Yes
The device is designed to "aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time," which directly supports diagnosis.
No
The device description explicitly states, "The device includes hardware to support interfacing with video endoscopy systems." This indicates it is not solely software.
Based on the provided information, the GI Genius System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- GI Genius Function: The GI Genius System works by processing live video images from an endoscope during a procedure. It analyzes these images in real-time to aid the endoscopist in detecting lesions. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions... in real time during standard white-light endoscopy examinations." This describes a tool used during a procedure, not for analyzing samples outside the body.
Therefore, the GI Genius System falls under the category of a medical device used in vivo (within the body) to assist in a diagnostic procedure, rather than an in vitro diagnostic device.
No
The input text does not contain any explicit statements indicating that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
Product codes
ONP, QNP
Device Description
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 compatible with Video Processors featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) output ports and endoscopic display monitor featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) input ports.
GI Genius is connected between the video processor and the endoscopic display monitor. When first switched on, the endoscopic field of view is clearly identified by four corner markers, and a blinking green square indicator appears on the connected endoscopic display monitor to state that the system is ready to function.
During live video streaming of the endoscopic video image, GI Genius generates a video output on the endoscopic display monitor that contains the original live video together with superimposed green square markers that will appear when a polyp or other lesion of interest is detected, accompanied by a short sound. These markers will not be visible when no lesion detection occurs.
The operating principle of the subject device is identical to that of the predicate device, this being a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device includes hardware to support interfacing with video endoscopy systems.
The baseline clinical validation for the subject device was conducted and reviewed in DEN200055 and is still applicable to the versions of the device that are the subject of this submission.
Mentions image processing
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.
Mentions AI, DNN, or ML
artificial intelligence-based device
Input Imaging Modality
standard white-light endoscopy imaging
Anatomical Site
colonic mucosal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
endoscopists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical testing:
- Verification of the revised software at the system level has been carried out, incorporating tests sufficient for the verification of the SRS.
- Validation of the revised software at the user level has been carried out, incorporating tests sufficient for the validation of the SRS.
- Verification of the three new SRS related to the internal library wrapper has been carried out at the system level and found to meet requirements.
- Validation of the new SRS related to the internal library wrapper at the user level has been carried out and a Validation Test Report was generated.
- Risk mitigation measures identified during Risk Management have been successfully verified or validated, as applicable.
- Electromagnetic Compatibility (EMC) and Electrical Safety compliance tests have been successfully completed on the hardware variant with the 4K video board according to IEC 60601-1 and IEC 60601-1-2 requirements, operating with software version 3.0.2.
- Tests according to the Standalone Performance Testing Protocol v2.0, submitted as part of the K211951 predicate device submission, have been repeated for the applicable parts of the subject device.
- As part of the above protocol, non-inferiority of performance of GI Genius with the Olympus CV-1500 EVIS X1 UHD video processor has been established by means of a per-frame assessment on 42 pre-recorded procedures. Since the Olympus CV-1500 simultaneously outputs both HD and UHD video signals, the non-inferiority test has been conducted on the UHD video signal only and on GI Genius System 200 only, as this represents the worst-case condition for compatibility testing.
- The footswitch and the USB K-switch send a single switching command to the GI Genius software to turn ON/OFF the overlay on target objects. The Electromagnetic Compatibility (EMC) and Electrical Safety compliance tests have been successfully completed on the footswitch and USB K-switch, according to IEC 60601-1 and IEC 60601-1-2 requirements.
- Given that the user interface of the GI Genius system will not change, a usability study has been performed with respect to use of the footswitch and USB K-switch, to verify the acceptability of the risk control measures.
Key Metrics
Lesion-based sensitivity: 86.5 %
Frame level performance (150 videos / 338 polyps):
True positive: 269,223
True negative: 5,239,128
False positive: 104,669
False negative: 192,567
True positive rate per frame: Mean: 58.30 %, % of polyps: 100 %
False positive rate per frame: Mean: 1.96 %
Frame-based TPr/FPr ROC curve, AOC: 0.796
False positive clusters per patient: 500 ms: 1 more than baseline
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1520 Gastrointestinal lesion software detection system.
(a)
Identification. A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including detection of gastrointestinal lesions and evaluation of all adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Testing must include:
(i) Standalone algorithm performance testing;
(ii) Pixel-level comparison of degradation of image quality due to the device;
(iii) Assessment of video delay due to marker annotation; and
(iv) Assessment of real-time endoscopic video delay due to the device.
(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(4) Performance data must demonstrate electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety testing for any hardware components of the device.
(5) Software verification, validation, and hazard analysis must be provided. Software description must include a detailed, technical description including the impact of any software and hardware on the device's functions, the associated capabilities and limitations of each part, the associated inputs and outputs, mapping of the software architecture, and a description of the video signal pipeline.
(6) Labeling must include:
(i) Instructions for use, including a detailed description of the device and compatibility information;
(ii) Warnings to avoid overreliance on the device, that the device is not intended to be used for diagnosis or characterization of lesions, and that the device does not replace clinical decision making;
(iii) A summary of the clinical performance testing conducted with the device, including detailed definitions of the study endpoints and statistical confidence intervals; and
(iv) A summary of the standalone performance testing and associated statistical analysis.
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May 19, 2023
Cosmo Artificial Intelligence - AI Ltd % Roger Gray VP Quality and Regulatory Donawa Lifescience Consluting Srl Piazza Albania 10 Rome, 00153 ITALY
Re: K231143
Trade/Device Name: GI Genius System 100 and GI Genius System 200 Regulation Number: 21 CFR 876.1520 Regulation Name: Gastrointestinal lesion software detection system Regulatory Class: Class II Product Code: ONP Dated: April 20, 2023 Received: April 21, 2023
Dear Roger Gray:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
GI Genius System 100 and GI Genius System 200
Indications for Use (Describe)
The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------ | ----------------------------------------------- |
N Prescription Use (Part 21 CFR
unter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Cosmo Pharmaceuticals. The logo features a stylized figure in light blue with an orange circle above it, followed by the word "COSMO" in large, teal letters. Below "COSMO" is the word "Pharmaceuticals" in a smaller, sans-serif font.
510(k) Summary
| 510(k) Reference: | K231143 | ||
|---|---|---|---|
| Device Name: | GI Genius System 100 and GI Genius System 200 | ||
| Type of 510(k) submission: | Special | ||
| Date of submission: | 15 May 2023 | ||
| 510(k) Owner and Submitter: | Cosmo Artificial Intelligence - Al Ltd | ||
| Riverside II, Sir John Rogerson's Quay | |||
| Dublin D02 KV60 | |||
| Ireland | |||
| FDA Establishment Reg. Number: | 3018899987 | ||
| Specification Developer: | Linkverse Srl | ||
| via Ostiense 131/L | |||
| 00154 Rome, Italy | |||
| Owner/Operator Reg. Number: | 3018901422 | ||
| 510(k) Application Correspondent: | Roger Gray | ||
| VP Quality and Regulatory | |||
| Donawa Lifescience Consulting | |||
| Piazza Albania 10 | |||
| 00153 Rome, Italy | |||
| Phone: | |||
| Email: | +39 06 578 2665 | ||
| rgray@donawa.com | |||
| FDA Product Code: | QNP | ||
| FDA Regulation Number: | 21 CFR 876.1520 | ||
| FDA Classification Name: | Gastrointestinal lesion software detection system | ||
| Classification Panel: | Gastroenterology and Urology | ||
| FDA Classification: | Class II |
Indications for Use:
The GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
The indications for use statement is identical to that for the original unmodified (predicate) device, as cleared under K211951.
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Image /page/4/Picture/1 description: The image shows the logo for Cosmo Pharmaceuticals. The logo features a stylized human figure in light blue with a yellow circle above its head, followed by the word "COSMO" in teal. Below "COSMO" is the word "Pharmaceuticals" in a smaller, lighter font.
Device Description:
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 compatible with Video Processors featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) output ports and endoscopic display monitor featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) input ports.
GI Genius is connected between the video processor and the endoscopic display monitor. When first switched on, the endoscopic field of view is clearly identified by four corner markers, and a blinking green square indicator appears on the connected endoscopic display monitor to state that the system is ready to function.
During live video streaming of the endoscopic video image, GI Genius generates a video output on the endoscopic display monitor that contains the original live video together with superimposed green square markers that will appear when a polyp or other lesion of interest is detected, accompanied by a short sound. These markers will not be visible when no lesion detection occurs.
The operating principle of the subject device is identical to that of the predicate device, this being a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device includes hardware to support interfacing with video endoscopy systems.
The baseline clinical validation for the subject device was conducted and reviewed in DEN200055 and is still applicable to the versions of the device that are the subject of this submission.
Design changes:
This Special 510(k) submission describes the design changes incorporated into GI Genius following FDA clearance under K211951. The device software version number as cleared under K211951 was 2.0.0; the device software version that is the subject of this Special 510(k) is 3.0.2.
Two types of design change are detailed in this submission. The first covers planned design changes that fall within the FDA guideline for submittal of a new 510(k), and the second covers minor design changes incorporated into the design that have been the subject of internal documentation. In addition, a labeling change is planned, to include a 4K UHD video processor in the list of compatible units in the User Manual.
As a result of user requests, optional accessories are planned to be offered for use with Gl Genius, these being a footswitch/USB K-switch to operate as follows:
- Footswitch: the GI Genius software overlays on the main display image the markers around the target objects. Such overlaid markers can be switched ON/OFF by the user by means of a button on the hardware unit front panel. The footswitch allows the user to operate the same switching function by foot as an alternative to the button on the front panel.
- . USB K-switch: Allows communication between the footswitch and the GI Genius hardware unit, by converting the footswitch signal to a command already recognized by the GI Genius software, which, as a result, does not need to be modified.
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Image /page/5/Picture/1 description: The image shows the logo for Cosmo Pharmaceuticals. The logo features a stylized human figure in light blue with a yellow circle above its head, followed by the word "COSMO" in blue, and the word "Pharmaceuticals" in a smaller font below it. The logo is clean and modern, with a focus on the company's name and its connection to the pharmaceutical industry.
A new endoscopy video processor is to be added to the list of video processors that are compatible with the GI Genius, namely the Olympus CV-1500 EVIS X1, which operates in accordance with the 4K UHD standard. The current GI Genius videoboard does not support the 4K UHD standard, so a new videoboard that does support 4K UHD functionality will be sourced and incorporated into the GI Genius that is the subject of this Special 510(k).
Changing the videoboard would normally necessitate a change to the polyp detection Al-based software for the device, so to allow maintenance of the current unchanged software version, the videoboard software communication will be interfaced by a new internal library, working as a 'wrapper'. The wrapper will convert the 4K UHD video stream from the video processor to HD as an input to the GI Genius software, and then convert the GI Genius software screen overlay from HD to 4K in output. Such design allows the original video frames of the endoscopy video processor not to be altered.
With the understanding that many GI Genius users will not require 4K UHD capability, at least for the time being, this design change will result in a range extension for the GI Genius, with two versions being available, these being:
- GI Genius System 100 (the current model, as cleared under K211951, but with new device model name, and ability to use footswitch/K-switch), and
- . GI Genius System 200 (the new model with 4K UHD capability, including full 4K UHD compatibility with the Olympus CV-1500 EVIS X1 video processor, and ability to use footswitch/K-switch).
Non-clinical testing:
The following verification / validation activities have been carried out:
- . Verification of the revised software at the system level has been carried out, incorporating tests sufficient for the verification of the SRS.
- . Validation of the revised software at the user level has been carried out, incorporating tests sufficient for the validation of the SRS.
- Verification of the three new SRS related to the internal library wrapper has been carried out at the system level and found to meet requirements.
- . Validation of the new SRS related to the internal library wrapper at the user level has been carried out and a Validation Test Report was generated.
- Risk mitigation measures identified during Risk Management have been successfully verified or validated, as applicable.
- . Electromagnetic Compatibility (EMC) and Electrical Safety compliance tests have been successfully completed on the hardware variant with the 4K video board according to IEC 60601-1 and IEC 60601-1-2 requirements, operating with software version 3.0.2.
- Tests according to the Standalone Performance Testing Protocol v2.0, submitted as part of the K211951 predicate device submission, have been repeated for the applicable parts of the subject device.
- As part of the above protocol, non-inferiority of performance of GI Genius with the Olympus CV-1500 EVIS X1 UHD video processor has been established by means of a per-frame assessment on 42 pre-recorded procedures. Since the Olympus CV-1500 simultaneously outputs both HD and UHD video signals, the non-inferiority test has been conducted on the UHD video signal only and on GI Genius System 200 only, as this represents the worst-case condition for compatibility testing.
- . The footswitch and the USB K-switch send a single switching command to the GI Genius software to turn ON/OFF the overlay on target objects. The Electromagnetic Compatibility (EMC) and
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Image /page/6/Picture/1 description: The image shows the logo for Cosmo Pharmaceuticals. The logo features a stylized human figure in light blue with a yellow circle above its head, followed by the word "COSMO" in large, teal letters. Below "COSMO" is the word "Pharmaceuticals" in a smaller, light gray font.
Electrical Safety compliance tests have been successfully completed on the footswitch and USB Kswitch, according to IEC 60601-1 and IEC 60601-1-2 requirements.
- . Given that the user interface of the GI Genius system will not change, a usability study has been performed with respect to use of the footswitch and USB K-switch, to verify the acceptability of the risk control measures.
The results of the above testing aid demonstration of substantial equivalence of the subject device with the predicate device, as the same test protocols have been used where applicable.
Substantial equivalence
The predicate device for the subject device is the pre-modification version of the same device, GI Genius, FDA-cleared under DEN200055 on 9 April 2021:
| Predicate Device: | GI Genius |
|---|---|
| Sponsor: | Cosmo Artificial Intelligence - Al Ltd |
| De Novo Number: | K211951 |
| Clearance Date: | 23 July 2021 |
| FDA Product Code: | QNP |
| Classification Name: | Gastrointestinal lesion software detection system |
| Regulation No: | 21 CFR 876.1520 |
| Class: | II |
Predicate device comparison table:
Table 1 provides evidence of substantial equivalence of the subject device with the predicate device.
| Table 1: Predicate device comparison table | |||||||
|---|---|---|---|---|---|---|---|
| Characteristic | Subject device | Predicate device | Comparison | ||||
| Device name | GI Genius | ||||||
| System 200 | GI Genius | ||||||
| System 100 | GI Genius | N/A | |||||
| Manufacturer | Linkverse Srl, Italy | Linkverse Srl, Italy | Same | ||||
| FDA clearance | This submission | K211951 | N/A | ||||
| FDA Reg name | Gastrointestinal lesion software | ||||||
| detection system | Gastrointestinal lesion software | ||||||
| detection system | Same | ||||||
| FDA Reg # | 21 CFR 876.1520 | 21 CFR 876.1520 | Same | ||||
| FDA Product Code | QNP | QNP | Same | ||||
| Indications for Use | The GI Genius System is a computer- | ||||||
| assisted reading tool designed to aid | |||||||
| endoscopists in detecting colonic | |||||||
| mucosal lesions (such as polyps and | |||||||
| adenomas) in real time during | |||||||
| standard white-light endoscopy | |||||||
| examinations of patients undergoing | |||||||
| screening and surveillance | |||||||
| endoscopic mucosal evaluations. | |||||||
| The GI Genius computer-assisted | |||||||
| detection device is limited for use | |||||||
| with standard white-light endoscopy | |||||||
| imaging only. This device is not | |||||||
| intended to replace clinical decision | |||||||
| making. | The GI Genius System is a computer- | ||||||
| assisted reading tool designed to aid | |||||||
| endoscopists in detecting colonic | |||||||
| mucosal lesions (such as polyps and | |||||||
| adenomas) in real time during | |||||||
| standard white-light endoscopy | |||||||
| examinations of patients undergoing | |||||||
| screening and surveillance | |||||||
| endoscopic mucosal evaluations. | |||||||
| The GI Genius computer-assisted | |||||||
| detection device is limited for use | |||||||
| with standard white-light endoscopy | |||||||
| imaging only. This device is not | |||||||
| intended to replace clinical decision | |||||||
| making. | Same | ||||||
| Video delay, signal in to | |||||||
| signal out | 0.74 µs | 1.52 µs | 1.52 µs | Improved for | |||
| System 200 * |
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Image /page/7/Picture/1 description: The image shows the logo for Cosmo Pharmaceuticals. The logo features a stylized human figure in blue with an orange circle above its head. To the right of the figure is the company name "COSMO" in blue, with the word "Pharmaceuticals" in a smaller font size underneath.
| Table 1: Predicate device comparison table | |||
|---|---|---|---|
| Characteristic | Subject device | Predicate device | Comparison |
| Lesion-based sensitivity | 86.5 % | 86.5 % | Same |
| Frame level performance | |||
| (150 videos / 338 | |||
| polyps)* | True positive: 269,223 | ||
| True negative: 5,239,128 | |||
| False positive: 104,669 | |||
| False negative: 192,567 | True positive: 269,223 | ||
| True negative: 5,239,128 | |||
| False positive: 104,669 | |||
| False negative: 192,567 | Same | ||
| True positive rate per | |||
| frame | Mean: 58.30 % | ||
| % of polyps: 100 % | Mean: 58.30 % | ||
| % of polyps: 100 % | Same | ||
| False positive rate per | |||
| frame | Mean: 1.96 % | Mean: 1.96 % | Same |
| Frame-based TPr/FPr | |||
| ROC curve, AOC | 0.796 | 0.796 | Same |
| False positive clusters | |||
| per patient | 500 ms: 1 more than baseline | 500 ms: 1 more than baseline | Same |
| Additional video | |||
| processor | Yes: Olympus | ||
| CV-1500 EVIS X1 | |||
| with UHD output | Yes: Olympus | ||
| CV-1500 EVIS X1 | |||
| with HD output | |||
| N/A | Same | ||
| Optional footswitch | Yes, connected via K-switch to USB | ||
| port | No | New functionality | |
| Electrical safety | IEC/EN 60601-1 (including | ||
| footswitch/K-switch) | IEC/EN 60601-1 | Same | |
| Electromagnetic | |||
| compatibility | IEC/EN 60601-1-2 (including | ||
| footswitch/K-switch) | IEC/EN 60601-1-2 | Same | |
| LAN port | Yes, non-functional to user | Yes, non-functional to user | Same |
Note *: UHD pixels are 8 times faster that HD pixels. To cope with this increase, 4 parallel processors are used, resulting in a twofold lower video delay value.
The subject device and the predicate device have many identical or similar characteristics. None of the identified differences introduce new aspects of safety or effectiveness.
Conclusion
The subject and predicate devices have identical indications for use and fundamental technological characteristics. Any differences in performance between the subject and predicate devices do not raise different questions of safety and effectiveness. The performance data demonstrate that the subject device is substantially equivalent to the predicate device, which is already in interstate commerce within the USA.