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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.

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 composed of software (namely, ColonPRO™ 4.0) and hardware (namely, GI Genius™ Module 100 and 200).

GI Genius™ Module 100 and 200 are compatible with Video Processors featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) output ports and endoscopic display monitors featuring SDI (SMPTE 259M) or HD-SDI (SMPTE 292M) input ports. GI Genius™ Module 200 is also compatible with Video Processors featuring the 4K UHD standard.

The GI Genius system 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 computerassisted 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 and the accessories given by the footswitch and the USB K-switch.

Here's an analysis of the acceptance criteria and study information for the GI Genius™ Module 100, GI Genius™ Module 200, and ColonPRO™ 4.0, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for each performance metric, but it does present a comparison table that shows the performance of the Subject Device (ColonPRO™ 4.0) against its Predicate Device (GI Genius™ System 100 and 200). The implication is that the subject device's performance, being "improved" or "same" compared to the already cleared predicate, meets the necessary equivalence for clearance.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document explicitly states the frame-level performance was assessed using 150 videos / 338 polyps. It doesn't specify if this refers to the number of patients or individual lesions.
• Data Provenance: The document does not provide information on the country of origin of the data or whether it was retrospective or prospective. It only mentions that "the baseline clinical validation for the subject device was conducted and reviewed in DEN200055 and is still applicable." Since this is a Special 510(k) for a software update (version 4.0.0 replacing 3.0.2), the primary performance data seems to derive from the re-training of the neural network rather than a new clinical study. The "Non-clinical testing" section mentions that "Tests according to the Standalone Performance Testing Protocol v2.0, submitted as part of the K231143 predicate device submission, have been repeated for the applicable parts of the subject device." This suggests the test set for this submission is the same as, or comparable to, that used for the predicate.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications for establishing the ground truth on the test set.

4. Adjudication Method for the Test Set

The document does not specify the adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention or present an MRMC comparative effectiveness study where human readers improve with AI vs. without AI assistance. The device is described as a "computer-assisted reading tool," suggesting it's intended to work alongside an endoscopist, but no study on human performance improvement with the device is provided in this submission or summary. It refers to the "baseline clinical validation" for the predicate device, but the details of that validation are not present here.

6. Standalone Performance Study (Algorithm Only)

Yes, a standalone performance study was done. The performance metrics listed in the table (Lesion-based sensitivity, Frame-level True Positive/Negative/False Positive/Negative, True positive rate per frame, False positive rate per frame, Frame-Based TPr/FPr ROC curve, AUC, False positive clusters per patient) all refer to the algorithm's performance without direct human-in-the-loop interaction for the purpose of these specific measurements. The "Non-clinical testing" section explicitly states: "Tests according to the Standalone Performance Testing Protocol v2.0, submitted as part of the K231143 predicate device submission, have been repeated for the applicable parts of the subject device."

7. Type of Ground Truth Used

The document implies the ground truth for polyps and lesions was used to evaluate detection performance. However, it does not explicitly state the method for establishing this ground truth (e.g., expert consensus, pathology, outcome data). Likely, for lesion detection in endoscopic videos, ground truth would typically be established by expert endoscopist review, potentially confirmed by pathology for detected lesions.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It only mentions "retraining of the neural network" as the source of improved detection performance for ColonPRO™ 4.0.

9. How the Ground Truth for the Training Set Was Established

The document does not specify how the ground truth for the training set was established.

Ask a specific question about this device

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.

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 provided text describes the acceptance criteria and the study that proves the GI Genius System (System 100 and System 200) meets these criteria, specifically in the context of its substantial equivalence to a previously cleared device.

1. Table of Acceptance Criteria and Reported Device Performance

The relevant performance metrics are presented as a comparison between the subject device (GI Genius System 100/200) and its predicate device. Since the claim is substantial equivalence, the performance of the subject device is shown to be at least as good as the predicate.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The performance data is based on 150 videos containing 338 polyps.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, it references the "baseline clinical validation for the subject device was conducted and reviewed in DEN200055," suggesting the source of this test data comes from a prior, perhaps larger, study. The testing for the current submission involved repeatable performance tests and non-inferiority testing on "42 pre-recorded procedures."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The document does not provide details on the number or qualifications of experts used to establish the ground truth for the test set. It mentions "per-frame assessment," which implies a detailed, possibly manual, review process.

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method (e.g., 2+1, 3+1).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study to assess how human readers improve with AI vs. without AI assistance. The study focuses on the device's standalone performance and its non-inferiority (or equivalence) to a predicate device, rather than human-AI collaboration.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance study was done. The document states:

• "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."
• The performance metrics provided in the table (True Positive, True Negative, False Positive, False Negative, ROC curve AOC, per-frame rates, and false positive clusters) are indicative of standalone algorithm performance.
• "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." This further supports standalone assessment.

7. The Type of Ground Truth Used

The ground truth appears to be based on expert consensus or a similar form of expert review, as evidenced by the "per-frame assessment" and lesion-level evaluation related to polyps and adenomas, which are typically confirmed by medical professionals. Pathology or outcomes data are not explicitly mentioned as the primary ground truth.

8. The Sample Size for the Training Set

The document does not explicitly state the sample size for the training set. It mentions that "GI Genius is an artificial intelligence-based device that has been trained to process colonoscopy images." The performance evaluation focuses on the test set, not the training set details.

9. How the Ground Truth for the Training Set Was Established

The document does not provide details on how the ground truth for the training set was established. It only states that the device "has been trained to process colonoscopy images containing regions consistent with colorectal lesions like polyps."

Ask a specific question about this device

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.

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 the following Video Processors: Fujifilm VP-7000, Olympus CV-180 EXERA II, Olympus CV-190 EXERA III, Fujifilm VP-4450HD, and Pentax EPK-i7000 Video Processor.

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.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the comparison to the predicate device (GI Genius v1.0.2). The goal of the study for GI Genius v2.0.0 was to demonstrate non-inferiority or improved performance compared to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The non-clinical testing for standalone performance used 150 videos containing 338 polyps.

The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, given that it's a re-training of a neural network with "additional procedure videos," it suggests a retrospective dataset of previously recorded endoscopy procedures.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned for the GI Genius v2.0.0. The evaluation focuses on standalone performance relative to its predicate.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone performance test was done. The text states: "Standalone Performance Testing has been carried out to assess the performance of the subject device in accordance with the same test protocol as that used for the predicate device, the results of which demonstrate substantial equivalence to the predicate device."

7. The Type of Ground Truth Used

The ground truth used for performance evaluation appears to be based on the identified "polyps and adenomas" within the procedure videos. While not explicitly stated as "expert consensus" or "pathology," the context of "colonic mucosal lesions (such as polyps and adenomas)" generally implies a clinical or pathological reference standard.

8. The Sample Size for the Training Set

The document mentions that the neural network was re-trained with "additional procedure videos" and "improved data augmentation," but it does not specify the sample size of the training set (number of videos or lesions).

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. However, given that the device aids in "detecting colonic mucosal lesions (such as polyps and adenomas)," it implies that these lesions were identified and annotated within the training videos, likely by expert endoscopists or pathologists.

Ask a specific question about this device

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™ 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. The device system generates a video on the main endoscopy display that contains the original live video together with superimposed markers (in the form of green boxes) that appear when a lesion is detected.

The GI Genius takes the Serial Digital Interface (SDI) output stream from the video endoscope processor as an input and then generates an SDI output stream to the existing monitor/display system containing the original video stream with additional markers superimposed on it. In essence, the system is inserted into the video stream just prior to it being displayed to the user/operator.

Here's a breakdown of the acceptance criteria and the study that proves the GI Genius device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample Sizes and Data Provenance

• Test Set (Standalone Performance):
  • Sample Size: 150 colonoscopy videos.
    • 105 videos included 338 excised polyps with histology confirmation.
    • 45 videos did not include polyps or lesions.
  • Data Provenance: Originally from a study titled, "The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy" [NCT01694966]. This study was a multi-arm study conducted without specific country information, but the clinical study (AID study) was performed in Italy. Given the standalone performance data was derived from the MMX trial, it is retrospective. The 150 videos for the Holdout Test Set were specifically without methylene blue.
• Clinical Study (AID Study):
  • Sample Size (mITT Population): 263 patients.
    • 136 patients randomized to GI Genius+colonoscopy.
    • 127 patients randomized to standard colonoscopy.
  • Data Provenance: Randomized, prospective, multicenter, controlled clinical investigation performed in Italy (Humanitas Research Hospital [Milan], Nuovo Regina Margherita Hospital [Rome], and Valduce Hospital [Como]).

3. Number of Experts and Qualifications for Test Set Ground Truth

• Standalone Performance Test Set:
  • Experts: A panel of five expert endoscopists reviewed video clips to establish the critical time frame for lesion detection and to define the endoscopists' first detection time for object-level performance.
  • Qualifications: Not explicitly stated beyond "expert endoscopists."
• Clinical Study Test Set (AID Study):
  • Experts: Six endoscopists were involved in conducting the colonoscopies and establishing ground truth through biopsy and histological confirmation.
  • Qualifications: Endoscopists with moderate endoscopy expertise, defined as an Adenoma Detection Rate (ADR) between 25% to 40%.

4. Adjudication Method for Test Set

• Standalone Performance Test Set:
  • The reference standard for true positives, true negatives, false positives, and false negatives was established by having endoscopists review video clips around histologically confirmed polyps and placing an annotation box around the polyps visible in each frame. The device's markers were then assessed for overlap with these annotations using an Intersection over Union (IoU) criterion. This implies expert consensus/annotation was the primary method, followed by a quantitative comparison. No explicit adjudication for disagreements among experts is described, rather, the experts created the ground truth.
• Clinical Study Test Set:
  • Ground truth for polyps in the clinical study was established by histological confirmation of excised lesions. The study design does not explicitly describe a multi-reader, multi-case (MRMC) adjudication process for detection, but rather the gold standard for lesion presence/type relied on pathology.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Yes, a form of MRMC comparative effectiveness study was done, in the clinical study (AID Study).
  • The study design involved six endoscopists, performing colonoscopies both with AI assistance (GI Genius) and without (standard colonoscopy). This is a direct comparison of human performance with and without AI assistance.
  • It was a randomized, prospective, multicenter, controlled clinical investigation.
  • Effect Size of Human Reader Improvement:
    • For the primary endpoint, Adenoma Detection Rate (ADR*): The GI Genius + colonoscopy group had an adjusted ADR* of 55.1%, while the standard colonoscopy group had an ADR* of 42.0%. This represents an absolute improvement of 13.1 percentage points with AI assistance (p

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