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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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