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The Avantis Medical Systems, Inc. Third Eye is indicated for use in the instrument channel of a conventional colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

The Third Eye System consists of both disposable portions and facility equipment. The disposable portions include the Third Eye Retroscope and Caps. The facility equipment portions of the device include the Third Eye Video Processor and accessories. The Third Eye is designed as an auxiliary device for use with a colonoscope during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eye Retroscope is inserted through the instrument channel of the colonoscope. As the Third Eye Retroscope emerges from the distal tip of the instrument channel of the colonoscope, it automatically bends 180 degrees to form a "J" shape. The Third Eye then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eye Video Processor is a piece of electrical equipment that acts as an interface for the Third Eye Retroscope, the video output signals, and user input controls. The output video signals from the Video Processor are displayed on a monitor for viewing by the physician. Application software that runs on the Video Processor allows the user to adjust the light intensity and various picture settings of the Third Eye Retroscope image.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Avantis Medical Systems, Inc. Third Eye® Retroscope® Auxiliary Endoscopy System, structured to answer your specific questions.

Based on the provided document, this is a Special 510(k) submission, which means the device is a modified version of an already cleared device (K083180). Special 510(k)s typically focus on demonstrating that modifications do not adversely affect safety and effectiveness, rather than proving initial efficacy. Therefore, a comprehensive de novo clinical study demonstrating efficacy against specific acceptance criteria is not expected or presented here.

1. Table of Acceptance Criteria and Reported Device Performance

No specific, quantified acceptance criteria or detailed device performance metrics (e.g., sensitivity, specificity, accuracy for diagnostic purposes) are provided in this Special 510(k) summary. The document states:

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

• Test Set Sample Size: Not applicable. No clinical or diagnostic performance test set (e.g., images for diagnostic accuracy) is described.
• Data Provenance: Not applicable. The "test dataset" described is limited to "Bench verification testing."

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

Not applicable. No expert-based ground truth establishment is described, as the testing was limited to bench verification.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring adjudication is described.

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

No. An MRMC comparative effectiveness study was not done or described in this document. The submission is a Special 510(k) for a device modification, focusing on engineering verification.

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

Yes, in a conceptual sense. The "testing" mentioned is "Bench verification testing." This means the device itself (the modified Retroscope and its components) was tested to ensure it met design inputs and performed as intended without human intervention in the diagnostic interpretation process. However, this is for the device's functionality (e.g., image quality, mechanics, material compatibility) and not for its diagnostic accuracy in identifying pathologies.

7. The Type of Ground Truth Used

For the bench verification testing, the "ground truth" would be the engineering specifications and design requirements for the device components. The testing aimed to verify that the modified components (specifically the hydrophilic coating) still met these pre-defined standards.

8. The Sample Size for the Training Set

Not applicable. This device is an endoscope system, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is an endoscope system, not an AI/ML algorithm that requires a training set.

Summary of the Study Presented (Special 510(k) Context):

The submission is a Special 510(k) for a minor modification to an already cleared device (K083180). The modification involved changing the hydrophilic coating on the camera polarizer from one manufacturer to another.

The study presented is "Bench verification testing." The purpose of this testing was to confirm that the modified device still met its original "design inputs and intended performance characteristics." The results, as stated, "demonstrate that the modified Third Eye Retroscope Auxiliary Endoscopy System performs as intended." This implies that physical and functional tests were conducted to ensure the new coating did not negatively impact the device's operation, sterility, or mechanical properties, thus confirming it remained substantially equivalent to the predicate device. No clinical efficacy study or diagnostic performance study was conducted or required for this type of submission.

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