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The Pathfinder Endoscope Overtube with Balloon is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder Endoscope Overtube with Balloon device consists of a hollow tube with a balloon at the distal end for use over a flexible gastrointestinal endoscope. The purpose of the balloon is to contact the lumen walls to provide stabilization to the distal end of the overtube within the GI tract. The endoscope is inserted through the proximal end of the device and comes out the distal end. The free space between the overtube and the endoscope is lubricated with water through the irrigation line by connecting to the irrigation/water Luer (female Luer lock fitting) and injecting water. The vacuum line is connected to free space within the device and is completely contained. A source of vacuum must be connected to the barb fitting per the diagram below for the overtube to transition between the flexible and rigid conditions. The balloon line is connected to an extrusion within the device that creates an air pathway from handle to the balloon. An inflation device must be connected to the Luer (male Luer lock fitting) to inflate and/or deflate the balloon. The handle rotator has two positions. The first position connects the device to atmosphere (vent) to stay in the flexible condition. The second position connects the device to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. Balloon inflation and deflation are actuated and controlled by an existing balloon controller unit within the endoscopy suite. The device must be connected to the balloon controller to transition into the inflated and deflated condition.

The provided text does not contain information about a study that proves a device meets acceptance criteria related to AI/algorithm performance.

The document is a 510(k) Premarket Notification from the FDA to Neptune Medical, Inc. for their "Pathfinder Endoscope Overtube with Balloon Device." It describes the device, its intended use, comparison to predicate devices, and summaries of functional and performance bench testing, and biocompatibility testing. It explicitly states:

• "No clinical testing was applicable to this submission."
• The entire submission focuses on a physical medical device, not an AI or algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI-powered device's performance, as the provided text pertains to a traditional medical device not involving AI.

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The Pathfinder Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder Endoscope Overtube (Pathfinder) device consists of a flexible overtube that may be connected to vacuum for rigidization. It is used with an endoscope for procedures in the gastrointestinal tract. The handle includes a vacuum line which is connected to free space within the device that is completely contained, forming the vacuumable volume. The handle rotator has two positions: the first connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible position, and the second position connects the vacuumable volume to a source of vacuum to transition to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to the surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.

The provided document describes a Special 510(k) submission for modifications to the Pathfinder Endoscope Overtube, specifically the addition of new sizes and a change in material durometer for the vacuum and irrigation line. This is NOT a typical AI/ML medical device submission, and therefore, many of the requested fields related to AI/ML performance, ground truth, and expert evaluation are not applicable.

Here's the breakdown of the information that can be extracted from the provided text, and where it indicates non-applicability for AI/ML specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a device modification submission for physical characteristics (sizes, material), the "acceptance criteria" are related to the functional and performance testing of the physical properties of the device, rather than a quantifiable performance metric like sensitivity or specificity for an AI algorithm. The document states that the "line extension was the subject of extensive testing under applicable design control requirements."

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

The document mentions "extensive testing" but does not provide specific sample sizes for each type of functional and performance testing (e.g., how many devices were tested for lubricity, how many cycles for rigidization).

• Sample Size (Test Set): Not specified in the provided summary.
• Data Provenance: The testing appears to be bench testing (laboratory-based) as stated in section 1.10: "the modified Pathfinder Endoscope Overtube has been shown to be safe through bench testing." This is not retrospective or prospective clinical data.

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

This question is not applicable as this submission is for a physical medical device (endoscope overtube) and not an AI/ML device that requires human interpretation for ground truth.

4. Adjudication method for the test set

This question is not applicable for the same reason as point 3.

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

This question is not applicable as this is not an AI-assisted device requiring human interpretation of results. No MRMC study was conducted.

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

This question is not applicable as this is not an AI algorithm.

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

This question is not applicable as there is no "ground truth" in the context of an AI algorithm's performance. The "truth" for this device modification is adherence to design specifications and successful functional performance as measured by engineering tests.

8. The sample size for the training set

This question is not applicable as this is not an AI/ML device, and therefore, there is no "training set."

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

This question is not applicable as there is no "training set" and no "ground truth" in the AI/ML context.

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The Pathfinder™ Endoscope Overtube is intended to be used with an endoscope to facilitate intubation, change of endoscopes, and treatment in the gastrointestinal (GI) tract in adult patients (22 years of age and older).

The Pathfinder™ Endoscope Overtube (Pathfinder™) device consists of a flexible overtube that may be connected to vacuum for rigidization via an attached stopcock and is used with an endoscope for procedures in the gastrointestinal tract. The stopcock is connected to the vacuum line which is connected to free space within the device and is completely contained, forming the vacuumable volume. The stopcock has two positions: the first position connects the vacuumable volume within the device to atmosphere (vent) to stay in the flexible condition, and the second position connects the device to a source of vacuum to the rigid condition. When transitioned to the rigid condition, the device maintains its shape at the time of rigidization, allowing the endoscope to advance or withdraw relative to the overtube with minimal disturbance to surrounding anatomy. When transitioned to the flexible condition, the device is able to move relative to the patient anatomy and endoscope for navigation through the GI tract. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations.

This document is a 510(k) premarket notification for a medical device called the Pathfinder™ Endoscope Overtube. It does not describe a study involving an AI-based medical device, nor does it include information on acceptance criteria for such a device.

The document focuses on demonstrating substantial equivalence to a predicate device (KMS Medical EndoGuide) primarily through:

• Comparison of technological characteristics: This involves comparing the design, materials, intended use, and other features of the new device to the predicate.
• Non-clinical performance data: This typically includes biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity) and mechanical testing (simulated use, lubricity, insufflation, insertion/removal, steering, navigation, rigidization/de-rigidization, endoscope compatibility).

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria for an AI-based device and the study proving it meets them. The document does not contain any of the following:

• Table of acceptance criteria and reported device performance for an AI device.
• Sample size used for an AI test set or data provenance.
• Number of experts or their qualifications for establishing ground truth for an AI test set.
• Adjudication method for an AI test set.
• MRMC comparative effectiveness study or human reader improvement with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used for an AI algorithm.
• Sample size for an AI training set.
• How ground truth for an AI training set was established.

The provided text is solely for a traditional medical device (an endoscope overtube) and its regulatory clearance process, not for an AI/ML-based diagnostic or therapeutic device.

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