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The Avantis Medical Systems, Inc. Third Eye Panoramic Auxiliary Endoscopy System - Resposable is indicated for use as an accessory to a conventional colonoscope to provide additional visualization and illumination of the colon for diagnostic purposes.

The Third Eye Panoramic Auxiliary Endoscopy System - Resposable consists of two main portions:

1. Resposable Panoramic Device (catheter with cameras and LED light sources at the distal end and connections to video processors at the proximal end) packaged and supplied as a non-sterile unit.
2. Facility Equipment: The non-disposable facility equipment portions of the device includes Third Eye Video Processors and cables (No change from predicate).

The TEPR is designed as an adjunct 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 TEPR is attached to the distal end of the colonoscope with a flexible clip. The TEPR 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 (forward) and the Panoramic Device (left and right lateral) are displayed simultaneously on three separate monitors, providing a panoramic image with a total angle of view of approximately 310° as shown schematically below.

The TEPR utilizes the same video processors as used in the predicate.

The provided text describes a medical device, the Third Eye Panoramic Auxiliary Endoscopy System - Resposable (TEPR), which is an accessory to a colonoscope for diagnostic purposes. The document is a 510(k) summary, indicating a submission to the FDA for market clearance based on substantial equivalence to a predicate device.

However, the document does not contain specific acceptance criteria, quantitative performance metrics, or detailed study results that would allow for the direct completion of the requested table and detailed study description. The summary states that "Bench verification testing was conducted to verify that the modified device meets the design inputs and intended performance requirements. Results demonstrate that the TEPR performs as intended. The cleaning and disinfection procedures were validated to demonstrate effectiveness." This is a general statement and lacks the specific data points requested.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's an attempt to answer the questions based only on the provided text, with explicit notation where information is missing:

1. Table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not specified in the provided text.
• Data provenance: Not explicitly stated, but the submission is for FDA clearance in the USA. The testing mentioned is "Bench verification testing."

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

• Not specified in the provided text. The document refers to "Bench verification testing" rather than human-reader studies requiring ground truth established by experts.

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

• Not applicable as no expert-adjudicated test set is described.

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 MRMC comparative effectiveness study is mentioned. The device is an "Auxiliary Endoscopy System," and the document focuses on its technical performance and safety, not on AI assistance or human reader improvement studies.

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

• The device itself is an auxiliary visualization system, not an algorithm. Therefore, "standalone (algorithm only)" is not directly applicable. The device's performance is inherently tied to its use by a human endoscopist. The document mentions "Bench verification testing" for the device's technical performance.

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

• For the "Bench verification testing," the ground truth likely refers to engineering specifications and performance standards rather than clinical "ground truth" like pathology. The document does not specify the exact nature of this "ground truth." For the cleaning and disinfection validation, the ground truth would be microbiological standards.

8. The sample size for the training set:

• Not applicable. This device is a hardware endoscopy accessory, not an AI algorithm that requires a training set.

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

• Not applicable. This device is a hardware endoscopy accessory, not an AI algorithm that requires a training set.

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