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The Enteroscopy Overtube is indicated for use to aid the insertion, advancement and removal of appropriately sized endoscopes and endoscopic devices during diagnostic and therapeutic endoscopic procedures in the upper gastrointestinal tract, including the small intestine.

The device is an endoscopic accessory designed to provide external support to and maintain a path for an endoscope to minimize the formation of gastric looping by the endoscope and to minimize mucosal pinching, while inserting, advancing, and removing the endoscope during endoscopic procedures in the upper gastrointestinal tract, including the small intestine. The device is intended for prescription use, is non-sterile, is intended for single use, and is not intended for reprocessing.

The provided text describes a 510(k) Premarket Notification for an "Enteroscopy Overtube." It outlines the device's purpose, classification, predicate devices, and indications for use. However, it explicitly states that "Performance testing consisted of functional bench testing" and does not include any information about clinical studies with human subjects, AI performance, or the establishment of ground truth in the context of diagnostic accuracy.

Therefore, many of the requested details about acceptance criteria, statistical studies, ground truth establishment, or AI-related metrics cannot be extracted from this document.

Here's a breakdown of the information that can and cannot be provided based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not detail specific acceptance criteria in a quantifiable manner, nor does it report specific performance metrics from functional bench testing. It broadly states: "Performance testing consisted of functional bench testing. All components that come into direct contact with the patient have a long history of use in medical devices and are biocompatible."

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

This information is not provided in the document. The testing mentioned is "functional bench testing," which implies testing of the device's physical properties and functionality, not a clinical test set with patient data.

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

This information is not applicable and not provided. "Ground truth" in the context of diagnostic accuracy is not relevant for a functional bench test of a physical medical device.

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was mentioned, nor is there any mention of AI in the document.

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

No standalone algorithm performance was mentioned, as the device is a physical medical instrument, not an AI algorithm.

7. The Type of Ground Truth Used

For the "functional bench testing," the "ground truth" would be engineering specifications and design requirements that the device must meet (e.g., tensile strength, flexibility, dimensions, ease of insertion/removal of endoscopes, minimization of looping and pinching). However, these specific specifications are not detailed in the provided text. No ground truth related to clinical outcomes or diagnostic accuracy in human subjects is mentioned.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The product is a physical device, and the testing described is functional bench testing. There is no mention of a "training set" in the context of an algorithm or diagnostic study.

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

This information is not applicable and not provided.

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