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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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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)
• 2. 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.

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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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 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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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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