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The OverStitch NXT Endoscopic Suturing System is intended for endoscopic placement of suture(s) and approximation of soft tissue.

The OverStitch NXT Endoscopic Suturing System (ESS) and accessories are intended for endoscopic placement of sutures and approximation of soft tissue within the gastrointestinal tract utilizing a single-channel endoscope. The system is comprised of the Needle Driver Assembly and Anchor Exchange Device (collectively referred to as ESS), and accessories such as the Tissue Helix or NXT Tissue Helix Pro, Suture Cinch and Suture-Anchor Assembly devices. All devices are sterile packaged and designed for single use and are manufactured from various thermoplastic, silicone, stainless steel and other medical grade materials.

The OverStitch NXT ESS is designed for compatibility with single channel endoscopes. The ESS is mounted onto the endoscope using polyester medical tape for the endcap assembly. The external catheter sheath has two working channels through which the Anchor Exchange and OverStitch accessories can operate, independent of the endoscope channel.

The handle of the Needle Driver Assembly is squeezed to actuate the needle body and exchange the proprietary Suture-Anchor Assembly with the Anchor Exchange to perform stitching operations.

The document is a 510(k) summary for the OverStitch NXT Endoscopic Suturing System, indicating that clinical performance data was not required to demonstrate substantial equivalence. Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance or AI algorithm output. The acceptance criteria and performance data mentioned in section {5} refer to non-clinical bench testing, functional testing on an ex vivo model, and packaging integrity, as well as biocompatibility.

Here's the information derived from the document regarding the non-clinical performance:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

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

This document describes non-clinical testing. It does not provide specific sample sizes for the bench tests, ex vivo model, or packaging integrity tests. The provenance of the data is from Apollo Endosurgery Inc./Boston Scientific's own testing procedures. The tests are prospective in the sense that they were conducted specifically for this submission.

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

This information is not applicable to the non-clinical and ex vivo testing described. There were no human expert evaluations in the context of clinical "ground truth" establishment for this submission as clinical data was not required.

4. Adjudication Method for the Test Set

Not applicable as it was non-clinical and ex vivo testing, not human expert adjudication.

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 study was conducted. This device is not an AI-assisted diagnostic or therapeutic device that would involve human readers.

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

Not applicable. This is a medical device (endoscopic suturing system), not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" was established by engineering specifications, validated test methods (e.g., ASTM standards), and comparison to the predicate device's established performance parameters. For the ex vivo model, the ground truth was the expected device function and intended use observed in the model.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable for the same reason as point 8.

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