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To be used in conjunction with an endoscope for foreign body removal or endoscopic procedures requiring multiple insertions of the endoscope into the lower or upper gastrointestinal tract.

The OverTube™ Endoscopic Access System is comprised of a single, polymer extrusion shaft reinforced with a metallic coil. The hub located at the proximal end of the device contains a cuff seal which can be inflated with air using a syringe to reduce loss of pressure when insufflation is used. The device is available in a single effective length of 27 cm with a tapered distal tip. The OverTube™ Endoscopic Access System will be delivered in a manner that a clinician may open one (1) OverTube per clinical procedure. The OverTube™ Endoscopic Access System will be provided in both sterile and non-sterile models. The sterile model is terminally sterilized by ethylene oxide (EO).

Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the OverTube™ Endoscopic Access System:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria for the OverTube™ Endoscopic Access System. Instead, it states that "Performance testing was conducted on the OverTube™ Endoscopic Access System to establish substantial equivalence." The tests conducted are listed as:

• Insertion and removal force requirements
• Shaft deflection
• Leakage rate
• Bond strength
• Foreign body removal
• Biocompatibility (in accordance with ISO 10993-1:2009)
• Sterilization cycle validation (in accordance with ISO 11135-1:2007)

The document asserts that these tests "show that the differences between the OverTube™ Endoscopic Access System and predicate device do not raise any questions regarding its safety and effectiveness." This implies that the device performed comparably to, or within acceptable limits for, its predicate device for each of these parameters, thereby meeting the implicit acceptance criteria for substantial equivalence.

Since specific numerical acceptance criteria and reported performance values are not provided, the table below reflects what is stated in the document about the performance evaluation.

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

The document does not specify the quantitative sample sizes for the performance tests (e.g., how many over-tubes were tested for insertion force or leakage rate). It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective. Given the nature of a 510(k) summary for a medical device that relies on substantial equivalence to a predicate, these tests are typically bench and/or in-vitro tests, not clinical studies involving patient data provenance from specific countries.

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

This information is not provided in the document. For bench/functional testing of a device like an overtube, the "ground truth" is typically established by engineering specifications, standard test methods, and comparison to the predicate device's known performance, rather than expert clinical consensus on a test set.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of the described performance testing. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies, especially those involving expert reviews for ground truth establishment, which is not the type of study 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

This information is not applicable/provided. The device described is an endoscopic access system (a physical medical device), not an AI algorithm or a diagnostic tool that involves "human readers" interpreting output. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this submission.

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

This information is not applicable/provided. As mentioned above, this filing concerns a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the functional performance tests (insertion/removal force, shaft deflection, leakage, bond strength, foreign body removal), the "ground truth" would be the engineering specifications, established test methodologies, and the performance characteristics of the legally marketed predicate device (Guardus® Disposable Overtube). The goal was to demonstrate that the new device performs acceptably within these engineering and predicate-based parameters.

For biocompatibility, the ground truth is established by the requirements of ISO 10993-1:2009.
For sterilization, the ground truth is established by the requirements of ISO 11135-1:2007.

8. The Sample Size for the Training Set

This information is not applicable/provided. As this is a submission for a physical medical device based on substantial equivalence and performance testing, there is no "training set" in the context of machine learning or AI.

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

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

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