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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 Eve 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 Eve 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 Eve then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eve 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.

The provided document is a 510(k) summary for the Avantis Medical Systems, Inc. Third Eye® Retroscope® Auxiliary Endoscopy System. This submission is a "Special 510(k)" indicating modifications to a previously cleared device (K091783).

Therefore, the primary focus of this document is to demonstrate that the modifications made to the device do not raise new issues of safety or effectiveness and that the modified device remains substantially equivalent to its predicate. The study described is bench verification testing rather than a clinical study assessing diagnostic performance against a ground truth.

Because this is a Special 510(k) for modifications to an existing device, a full clinical study with specific acceptance criteria related to diagnostic performance (like sensitivity, specificity, accuracy) using a human-in-the-loop or standalone algorithm performance on a clinical test set is not typically required or presented in such a submission. The focus is on demonstrating that the changes do not negatively impact safety or effectiveness.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes "Bench verification testing." This typically involves laboratory-based tests of the device's hardware and software specifications, rather than clinical data from human subjects. Therefore, there is no human "test set" in the traditional sense of clinical data reported in this document. The testing is of the device's components and system functionality. If any data was used, it would likely be synthetic or internal test data generated to assess performance against engineering specifications. Data provenance is not applicable as this is not a study using retrospective or prospective patient data.

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

This is not applicable as the testing described is bench verification testing against engineering specifications, not a clinical study requiring expert-established ground truth on patient data.

4. Adjudication Method for the Test Set

This is not applicable as there is no clinical test set requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence of the modified device through bench testing, not on assessing the improvement of human readers with AI assistance. The device itself is an auxiliary endoscopy system providing visualization, not an AI-assisted diagnostic tool in the typical sense of interpreting images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is an auxiliary endoscopy system, not an AI algorithm performing standalone interpretation. Therefore, a standalone algorithm performance study was not done or reported. The device provides images to a physician, who then performs the interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

As this was bench verification testing, the "ground truth" would be the design specifications and engineering requirements for the device's performance (e.g., video quality, illumination, mechanical movement, electrical functionality).

8. The Sample Size for the Training Set

This is not applicable as the device is not an AI algorithm that requires a training set of data.

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

This is not applicable as the device is not an AI algorithm that requires a training set with established ground truth.

In summary: The provided 510(k) summary for the Third Eye® Retroscope® Auxiliary Endoscopy System describes modifications to a previously cleared device. The "study" mentioned is bench verification testing aimed at confirming that the modified device still meets its design specifications and intended performance, and that the changes do not introduce new safety or efficacy concerns, thus maintaining substantial equivalence to its predicate. It is not a clinical study involving human subjects or AI algorithm performance assessment.

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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 during a colonoscopy procedure. After a colonoscope has been advanced to the cecurn, 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 Eve 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 Eve Retroscope image.

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Avantis Medical Systems' Third Eye Retroscope Auxiliary Endoscopy System:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in terms of a specific number of patients or cases. The document refers to a "multi-center post-market study."
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Prospective.

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

• This information is not provided in the document. The document states that the Third Eye "improves detection of polyps and adenomas," implying a comparison, but it does not detail how the ground truth for "polyps and adenomas" was established in the clinical study (e.g., standard colonoscopy findings, pathology, or a panel of experts).

4. Adjudication Method for the Test Set

• This information is not provided in the document.

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

• It states that a clinical study "demonstrate(s) that retrograde viewing of the colon with the Third Eye improves the detection of polyps and adenomas compared to traditional colonoscopy alone." This indicates a comparative effectiveness study, however, it's not explicitly labeled as an MRMC study and the specific effect size quantifying "how much human readers improve with AI vs without AI assistance" is not provided. The document only states that the results were "statistically significant." The device itself is an auxiliary endoscope, not an AI, so the framing of "human readers improve with AI vs without AI assistance" isn't directly applicable in this context. It's about improved detection with the device vs. without.

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

• No, this was not done. The device is an auxiliary endoscopic system designed for human use during a colonoscopy to provide additional visualization. It is not an algorithm that operates independently.

7. The Type of Ground Truth Used

• The document states the study measured "detection of polyps and adenomas." While not explicitly defined as pathology, in the context of colonoscopy clinical trials, pathology from biopsied or resected lesions is the generally accepted gold standard for confirming polyps and adenomas. However, the document does not definitively state that pathology was the sole or primary ground truth method.

8. The Sample Size for the Training Set

• This information is not applicable/not provided. The Third Eye Retroscope is a medical device, not an AI algorithm that requires a "training set" in the machine learning sense. The clinical study described is for validation of the device's performance.

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

• This information is not applicable/not provided for the same reason as point 8.

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The Avantis Medical Systems, Inc. Third Eye Retroscope Auxiliary Endoscopy System is intended for use in the instrument channel of a standard colonoscope to provide retrograde illumination and visualization of the colon for diagnostic purposes.

The Third Eye Retroscope Auxiliary Endoscopy System is designed as an auxiliary device for use during a colonoscopy procedure. After a colonoscope has been advanced to the cecum, the Third Eye Retroscope auxiliary Endoscopy device is inserted through the instrument channel of the colonoscope. As the auxiliary device emerges from the distal tip of the instrument channel of the colonoscope, the auxiliary device automatically bends 180 degrees to form a "J" shape. The device then provides a continuous retrograde image of the colon throughout the process of withdrawal of the colonoscope. The Third Eye Retroscope is deployed through the instrument channel of a colonoscope in what is commonly referred to as a mother-daughter configuration. As a result, only approximately 4 cm of the distal tip of the device protrudes from the distal end of the colonoscope's instrument channel except for a few seconds during insertion and removal, when up to 9 cm of the distal tip extends beyond the end of the colonoscope. Any contact of the device with the colonic mucosa is transitory. The system consists of both disposable portions, and facility equipment. The disposable portions include the Third Eye Retroscope and Cap. The Third Eye Retroscope is an endoscope that consists of a distal section, flexible insertion tube and proximal section. The distal section houses an imaging sensor, light source and related circuitry. The flexible insertion tube consists of a standard braided catheter with electrical wires located inside the lumen. These wires carry signals from the distal region to the proximal region. The proximal section includes a torquing knob, flexible wire extension region, and electrical connector. The Third Eye Cap with polarizing filter is placed on the distal end of the colonoscope. The facility equipment portions of the device include the Third Eye Retroscope Video Processor and accessories. The video processor is a piece of electrical equipment that acts as an interface box for the Third Eve 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 various picture settings of the Third Eye Retroscope image and adjust the light intensity of the Retroscope. Additionally, the software facilitates the capture of still images, the export of these still images, and allows a user to save system settings under a profile name.

This document is a 510(k) summary for the Avantis Medical Systems, Inc. Third Eye™ Retroscope™ Auxiliary Endoscopy System. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study design with performance metrics typically associated with AI/ML device evaluations.

Therefore, many of the requested data points (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set sample size, and ground truth for training set) are not applicable or not provided in this type of regulatory submission. This document predates the widespread use of sophisticated AI/ML in medical devices and the associated regulatory expectations for performance studies.

However, I can extract the available information related to performance and create a table for what is provided.

Here's the breakdown of the information based on the document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices in terms of intended use, operation, materials, and safety through in vitro bench testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified. The document only mentions "in vitro bench testing" without providing details on participants or specific datasets.
• Data Provenance: Not specified. Given it's "in vitro bench testing," it likely refers to laboratory testing and not human or animal study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Number of Experts/Qualifications: Not applicable/not specified. The testing described is "in vitro bench testing," which typically does not involve expert readers establishing ground truth for diagnostic accuracy in the way AI/ML systems are evaluated.

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

• Adjudication Method: Not applicable/none specified. This type of adjudication is relevant for studies involving human interpretation and ground truth establishment, which isn't described here.

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

• MRMC Study: No. This document is for a traditional medical device (an auxiliary endoscope system), not an AI/ML diagnostic system. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" was not performed.

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

• Standalone Performance: Not applicable. The Third Eye Retroscope is an auxiliary endoscopy system used by a physician (human-in-the-loop). It's a visual aid, not an autonomous diagnostic algorithm. While it has "application software that runs on the video processor," this software adjusts picture settings and light intensity, and facilitates image capture, rather than providing autonomous diagnostic interpretations. The document refers to "in vitro bench testing" for performance evaluation, which is likely about image quality, functional integrity, and safety attributes of the device itself.

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

• Type of Ground Truth: Not explicitly stated or required for this type of 510(k) submission which relies on substantial equivalence based on physical and functional characteristics of the device tested via "in vitro bench testing." For imaging performance, the "ground truth" would likely be objective measurements of image resolution, clarity, field of view, illumination, and mechanical reliability, compared against expected performance or established standards.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This device is not an AI/ML product developed using training datasets in the conventional sense. Its "application software" serves control and display functions, not machine learning.

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

• Ground Truth for Training Set: Not applicable for the reasons mentioned above.

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