(6 days)
The Viatronix V3D Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of screening a colon to detect polyps, masses, cancers and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. It generates a centerline for guided interactive navigation and fly through of the entire colon, and also includes a reporting facility to enhance workflow for screening a colon. It is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image studies utilizing PC hardware.
The Viatronix V3D Colon contains all of the required hardware and software components to provide interactive 3D and 2D views of diagnostic CT and MR scan images of the colon. The views include both inner and outer surface 3D volume rendered images as well as orthogonal and multiplaner reformatted 2D images. This ability to view the dataset in different perspectives from which it was acquired is performed by first transferring DICOM images from the MR or CT scanners to the Viatronix V3D Colon, which automatically identifies regions of interest and displays these regions to the user in the above mentioned views. The user can then navigate freely within the dataset/region of interest or follow automatically computed paths to fly through the colon or around the outside of the colon structure. Measurements of the size of colon polyps, masses or lesions can be made for patient screening and for planning treatment.
Here's a summary of the acceptance criteria and study information for the Viatronix V3D Colon, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria with specific numerical targets. Instead, the acceptance criteria are implicitly defined by the goals of the clinical testing, focusing on functionality, accuracy, and substantial equivalence to predicate devices.
| Acceptance Criteria (Inferred from Clinical Testing Goals) | Reported Device Performance |
|---|---|
| Generate an accurate 3D model of the entire colon | Verified that an accurate 3D model of the entire colon is generated. |
| Enable fly-through in the 3D model of the entire colon | Verified that fly-through in the 3D model of the entire colon is possible. Demonstrated the ability to fly through and visualize the entire colon. |
| Enable viewing of 2D and MPR images of the entire colon | Verified that viewing 2D and MPR images of the entire colon is possible. |
| Accurate measurements (e.g., of polyps, masses) using a phantom | Using a phantom, verified that measurements are accurate. Demonstrated the ability to visualize and measure polyps, masses, and lesions for patient screening. Accuracy was assessed by comparing test results with actual phantom structures. |
| Ability to visualize structures (compared to optical endoscopy) | In comparison to optical endoscopy, the Viatronix V3D Colon is able to visualize structures of similar size and shape. Qualitative judgment by radiologists indicated accurate and medically useful rendering. |
| Substantial equivalence in essential features to predicate devices (e.g., quality, effectiveness, rendering accuracy) | Clinical data reviewed by a radiologist experienced with predicate devices found the Viatronix V3D Colon "substantially equivalent in essential features," with improvements in speed of rendering and ease of segmentation. Non-clinical phantom testing determined its level of accuracy to be "substantially equivalent to that of its predicate devices." Concluded to be substantially equivalent. |
| Perform as intended with a broad sampling of input data (core functionality: fly-through and visualization) | Each patient was assessed as to whether the core functionality permitted fly-through and visualization. |
| Reliability and ease of use | The product has shown itself to be reliable, easy to use, and capable of rendering useful 3D medical images. |
2. Sample Size Used for the Test Set and Data Provenance
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Non-clinical (Phantom) Test Set:
- Sample Size: Not explicitly stated, but implies multiple "structures of a known size and distance" inserted into the phantom.
- Data Provenance: N/A (phantom data)
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Clinical (Human) Test Set:
- Sample Size: Not explicitly stated, described as "broad sampling of input data" and "each patient was assessed."
- Data Provenance: Prospective (clinical studies were performed under IRB overview, which included Patient Consent Forms). Country of origin is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
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Non-clinical (Phantom) Test Set:
- Number of Experts: One independent reviewer.
- Qualifications: "An independent reviewer." Specific qualifications (e.g., years of experience, medical specialty) are not detailed.
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Clinical (Human) Test Set:
- Number of Experts: One radiologist.
- Qualifications: "A radiologist who determined that the rendering was accurate and medically useful. The radiologist was experienced with the predicate devices." Specific years of experience or subspecialty are not detailed.
4. Adjudication Method for the Test Set
- For the non-clinical phantom study, the "independent reviewer" compared test results with the actual phantom to assess accuracy. This implies direct comparison rather than a formal adjudication process involving multiple experts for disagreement resolution.
- For the clinical study, a single radiologist made the determination of accuracy and medical usefulness. There is no mention of a multi-reader adjudication method (e.g., 2+1, 3+1).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus human readers without AI assistance was not explicitly described. The clinical evaluation involved a single radiologist assessing the device's output and comparing it qualitatively to optical endoscopy and predicate devices.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the testing described appears to be a standalone evaluation of the device. The system automatically identifies regions of interest, displays them, generates centerlines for navigation, and provides measurement tools. The radiologist then reviews and uses this output. The evaluation focuses on the device's ability to render images, permit navigation, and make accurate measurements, which are functions of the algorithm without continuous human-in-the-loop intervention for its primary output generation. The radiologist's role was to review and determine accuracy and usefulness, implying the device produced results first.
7. The Type of Ground Truth Used
- Non-clinical (Phantom): Physical ground truth – "structures of a known size and distance" inserted into the phantom, against which the device's measurements were compared.
- Clinical (Human): Relative ground truth –
- Qualitative judgment by a radiologist.
- Comparison with "optical endoscopy" for visualization capabilities.
- Comparison to the performance of predicate devices.
- The "System Clinical Test Results (Visualization of Polyps)" suggests comparison to pathology or clinical findings might have been part of the evaluation, but the direct method for establishing truth related to specific lesions is not fully detailed beyond "qualitative judgment."
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. The focus is on the evaluation of the finalized device.
9. How the Ground Truth for the Training Set was Established
Since no training set information is provided, how its ground truth was established is also not present in the document.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).