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510(k) Data Aggregation
(255 days)
The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.
Third Eye Panoramic Auxiliary Endoscopy System consists of two main portions:
- Disposable device components packaged and supplied together as a 1. single-use sterilized unit.
- a. The Panoramic Device: (catheter with cameras and LED light sources at the distal end and connection to video processors at the proximal end)
- b. Attached Water Module to rinse the camera lenses: (catheter with water rinse sprayer distal end and connection to water source at the proximal end)
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- Facility Equipment: The non-disposable facility equipment portions of the device include two Third Eye Video Processors and cables (No change from predicate except for a minor label change).
The Panoramic Device is designed as an accessory device for use with a standard colonoscope to provide lateral and partial retrograde visualization and illumination of the colon during a colonoscopy procedure. Prior to insertion of a standard colonoscope, the Panoramic Device (including the Water Module) is attached to the distal end of the colonoscope with a flexible clip. The Panoramic Device travels with the colonoscope and provides continuous left-side and right-side views of the colon that supplement the forward view of the colonoscope. The images from the colonoscope and the Panoramic Device are displayed simultaneously on three separate monitors, providing a panoramic image with a total angle of view of approximately 310° as shown schematically below.
Here's a breakdown of the acceptance criteria and study information for the Third Eye Panoramic Auxiliary Endoscopy System, based on the provided document:
This device is not an AI/ML device, therefore, many of the typical acceptance criteria and study components related to AI/ML devices (e.g., standalone performance, MRMC studies, training set details) are not applicable. The device is an accessory to a colonoscope that provides additional visualization.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is not an AI/ML device, the acceptance criteria are focused on the device's functional performance, safety, and its ability to provide additional visualization without obstructing the colonoscope. The document does not explicitly state quantitative acceptance criteria in a table format, but rather describes the desired performance outcomes.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance: | |
| Provide additional visualization and illumination of the colon. | The Panoramic Device provides continuous left-side and right-side views that supplement the forward view of the colonoscope. Images from both devices are displayed simultaneously, offering a panoramic image with a total angle of view of approximately 310°. The side-viewing cameras were useful for detecting lesions not found in the colonoscope’s forward view. |
| Maintain colonoscope function and not interfere with its operation. | The presence of the Third Eye Panoramic Device did not interfere with any of the functions of the colonoscope. Its external attachment allows the colonoscope channel to remain unobstructed, facilitating use during both intubation and withdrawal, and permitting biopsies or polypectomies without removal. |
| Assist in determining colonoscope deflection. | The left and right-lateral views assist the endoscopist in determining the most appropriate direction to deflect the colonoscope’s tip during intubation, potentially reducing patient discomfort and perforation risk. |
| Safety: | |
| Meet design specifications and safety requirements. | Bench verification testing demonstrated that the modified device meets design inputs and intended performance requirements. All changes from the predicate device were subjected to risk analysis and verified to meet current design specifications. |
| No new or unresolved issues for safety and efficacy. | The testing described demonstrates that the proposed Third Eye Panoramic Auxiliary Endoscopy System does not raise any new or unresolved issues for safety and efficacy. |
| Operability: | |
| Simplification of operation compared to predicate. | The Panoramic Device reduces the complexity of setup and simplifies operability compared to the Retroscope (predicate) by being externally attached to the colonoscope rather than inserted through its channel. This allows it to remain in place during various procedure phases and when instruments are used. Results from the feasibility study supported the operability of the device. |
2. Sample Size Used for the Test Set and Data Provenance
The document refers to a clinical feasibility study for performance and operability.
- Sample Size: Initial 17 subjects.
- Data Provenance: Conducted at New York Hospital Queens Medical Center (USA). This indicates prospective data collection from a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of "experts" used to establish ground truth in the context of lesion detection for the 17-subject feasibility study. For a device like this, the "ground truth" would implicitly be the clinical findings made by the performing endoscopist(s) during the colonoscopy procedures, potentially confirmed by pathology for detected lesions. The document only mentions that the side-viewing cameras were useful for detecting lesions that were not found in the colonoscope's forward view, implying that clinicians using the device made these observations.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method for the test set. Given this was a feasibility study for an accessory device, the assessment of usefulness and non-interference likely came from the endoscopist(s) performing the procedures, integrated into their clinical decision-making.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC study was not done for this device. This is not an AI/ML device; it is a mechanical and optical accessory providing additional visualization. Therefore, metrics like "human readers improve with AI vs. without AI assistance" are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study was not done. This device is an accessory that enhances human visualization; it does not operate as a standalone algorithm.
7. The Type of Ground Truth Used
For the clinical feasibility study, the "ground truth" for the device's performance regarding lesion detection would be the clinical findings and observations made by the endoscopist during the procedures, potentially corroborated by pathology results for any detected and biopsied lesions. The key finding mentioned, "side-viewing cameras were useful for detecting lesions that were not found in the colonoscope's forward view," suggests that the ground truth was the actual presence of lesions identified by the physician using the device.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware accessory with optical components, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable. As established, there is no training set for this type of device.
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