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The separately-licensed CT Colonography option is intended for closely examining the lumen of the colon using features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.

Vitrea® CT Colon Analysis software generates 2D and 3D images of the colon to allow close examination of the lumen of the colon, thereby increasing the speed and ease of locating and analyzing suspected polyps, masses and lesions. Vitrea®CT Colon Analysis software has the following features:

• . Auto-seqmentation of the colon
• . Segmentation editing
• . Axial imaging, multi-planar reformatting and 3D views
• . Manual and automatic endoluminal fly-through of the colon
• . Eye-based navigation for performing fly-through and target-based navigation for examining POI and Reverse View mode
• MPR eye placement to adjust view direction down lumen
• . Transparent wall view of the colon with a field-of-view cone to act as a reference during fly-through
• . Dual Volume Viewer window format for side-by-side comparison of prone and supine studies
• Ability to mark points in the colon with arrows; arrow are hidden from view when you fly too close
• SPACE BAR to step through images containing arrows
• Prone/supine registration .
• . Polyp Probe tool to select and characterize polyps
• Polyp assessment using the C-RADS guidelines
• . Fly-through image batches and digital movies
• Special report template that contains an anatomically-labeled diagram of the colon for . easier documentation of findings, as well as a C-RADS report template
• . Fly-through keyboard shortcuts
• . Automatic fluid/stool tagging and subtraction

Vitrea® CT Colon Analysis software deploys from the Vitrea® Platform, cleared under K150258, Vitrea®, Version 7.0 Medical Image Processing Software. The software provides imaging information as an assistance to the physician. The software does not provide diagnosis or determine the recommended medical care.

Here's an analysis of the acceptance criteria and study information for the Vitrea® CT Colon Analysis software, based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative metrics directly linked to the device's performance for functions like auto-segmentation accuracy, polyp detection sensitivity, or specificity. Instead, the document focuses on demonstrating substantial equivalence to a predicate device and a reference device, primarily through feature comparison and qualitative assessment of enhancements.

The core "acceptance criteria" from the document's perspective appear to be:

• The software successfully performs its described functions (auto-segmentation, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, transparent wall view, Electronic Bowel Cleansing).
• The new Electronic Bowel Cleansing (EBC) feature does not negatively impact the device's safety or effectiveness compared to the predicate.
• The device adheres to relevant standards (DICOM, IEC 62304, ISO 14971).
• The medical benefits outweigh the residual risks.

Given this, the "reported device performance" is largely qualitative and focused on functionality and safety rather than specific quantitative metrics.

• Device successfully performs features such as auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, and transparent wall view.
• Device successfully performs Electronic Bowel Cleansing (EBC) (automatic fluid/stool tagging and subtraction).
• EBC feature does not affect intended use, indications for use, or fundamental scientific technology of the cleared predicate.
• EBC feature does not raise new questions of safety or effectiveness.
• The risk of incorrectly removing polyps when hiding tagged material in 3D is acceptably low (observed 0% during validation).
• Device is safe and effective as the predicate device.
• Device compiles with voluntary recognized consensus standards (DICOM, ISO 14971, IEC 62304). | - Software generates 2D and 3D images as described.
• All listed features (auto-segmentation, axial imaging, multi-planar reformatting, fly-through, simultaneous display of prone and supine images, transparent wall view) are successfully implemented and function.
• Electronic Bowel Cleansing functions by electronically removing residual fecal material tagged with an agent.
• The added EBC feature does not alter the intended use, indications for use, or fundamental scientific technology.
• Verification and validation testing demonstrated the modified device is as safe and effective as the predicate, raising no different questions of safety and effectiveness.
• "The risk of incorrectly removing polyps when hiding tagged material in 3D (which was observed 0% of the time during our validation) has been mitigated because the polyps can still be seen in 2D."
• Device operates according to defined requirements and fulfills standards. |

Study Details for Vitrea® CT Colon Analysis software (focus on Electronic Bowel Cleansing feature):

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: "datasets based on real patient data and phantoms." The specific number of real patient datasets or phantoms is not provided in this summary.
   • Data Provenance: "real patient data and phantoms." The country of origin is not specified. The studies were likely retrospective as they refer to "real patient data" being used for testing.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document mentions "experienced professionals" for usability testing as part of internal validation and "experienced users" for external validation. However, it does not specify the exact number or qualifications of experts used to establish the ground truth for the test set (e.g., diagnosis of polyps, accurate segmentation). The ground truth establishment for the EBC feature likely involved comparing the "cleansed" images to the original data and potentially to expert assessments, but the details are not provided.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • No adjudication method details are provided in this summary.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No MRMC comparative effectiveness study is explicitly mentioned for the enhancement (Electronic Bowel Cleansing). The general clinical performance tests "demonstrate performance, safety, and effectiveness," but it's not described as a comparative MRMC study measuring human reader improvement with/without AI assistance. The statement "The risk of incorrectly removing polyps when hiding tagged material in 3D (which was observed 0% of the time during our validation) has been mitigated because the polyps can still be seen in 2D" suggests some form of evaluation but not necessarily a formal MRMC study on reader performance.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, implicitly. The "Verification" section confirms "Test cases were executed against the system features and requirements" and "Validation of the software that included phantom testing." The "Internal Validation and Phantom Testing" section also states "Internal validation included internal user acceptance testing using real scans as well as synthetic phantoms. The validation criteria covered image qualitative comparison of segmentation to previous releases, quantitative evaluation of polyp diameter accuracy using phantom datasets, and run time performance evaluation." This indicates algorithm-only performance assessment.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the Electronic Bowel Cleansing feature, the ground truth appears to be based on "real patient data and phantoms." For "quantitative evaluation of polyp diameter accuracy using phantom datasets," it would be the known dimensions within the phantoms. For "image qualitative comparison of segmentation," it would be comparison to previous releases or potentially expert-reviewed segmentation. Explicit pathology or outcomes data as ground truth for the EBC feature's "acceptance" is not specified here, though the general product's goal is to aid in detecting "suspected polyps, masses and lesions."

7. The sample size for the training set:

   • The document does not provide information on the sample size used for training the algorithms, nor does it explicitly state if machine learning was used for the EBC feature (though the term "algorithm" is used). This document focuses on the validation of the enhanced feature rather than the initial development of the core CT Colon Analysis algorithms.

8. How the ground truth for the training set was established:

   • Not specified, as information regarding a dedicated training set is not provided in this summary.

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