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The EndoGastric Solutions EsophyX Z Device with SerosaFuse is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

The EndoGastric Solutions EsophyX Z Device with SerosaFuse Fasteners and Accessories is a prescription use only, disposable, single use system consisting of an all mechanical, flexible fastener delivery device with user controls outside the patient's body. The transoral device and tissue fasteners are provided sterile (EO). A separate, commercial endoscope operating independently down the center of the device's flexible shaft lumen provides visualization of the procedure from device insertion through extraction. Two polypropylene fasteners are loaded from a replaceable fastener cartridge containing ten fasteners for each channel. The loaded fasteners are pushed simultaneously from the proximal device end, to the distal end down two separate channels via lumens in a flexible shaft where they are then in position for deployment into the tissue. The operator, controlling the distal end of the device through the mechanical controls captures and positions a fold of tissue at the gastroesophageal junction. The delivery trigger mechanism deploys both fasteners simultaneously at the captured tissue position, creating a permanent surgical fundoplication. Additional fasteners are used as needed to complete the valve restoration.

This document is a 510(k) Premarket Notification for the EsophyX® Z Device with SerosaFuse Fasteners and Accessories. It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study. Therefore, much of the requested information regarding acceptance criteria and a study design with specific numbers (sample sizes, ground truth establishment, expert qualifications, etc.) is not present in this document.

However, I can extract the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a formal table of acceptance criteria with quantitative performance metrics for the device. Instead, it relies on demonstrating that the modified device "met the design specifications and user needs" and performed "as well as the predicate device."

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

The document mentions "cadaver and animal labs" for "design validation" and "fastener deployment in various tissue types," but it does not provide specific sample sizes for these tests. The data provenance is experimental (cadaver and animal labs), not derived from human patient data in a test set. It does not mention country of origin or whether it was retrospective or prospective in detail, but given the nature of cadaver and animal labs, it would be prospective in an experimental setting.

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

This information is not provided in the document. The document refers to "design specifications and user needs" and "biocompatibility testing," which are typically evaluated against established technical standards and test protocols, not directly against ground truth established by medical experts in a clinical study context for performance metrics.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a human-read test set requiring adjudication in the context of device performance metrics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not mentioned or performed as the purpose of this submission is to demonstrate substantial equivalence of a medical device (EsophyX® Z Device with SerosaFuse Fasteners and Accessories) to a predicate device (EsophyX Z System), not to assess human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a medical instrument (Endoscopic Clip Applier, Implantable Fastener and Accessories) and not an algorithm or AI software. Therefore, an "algorithm only" performance study was not conducted.

7. Type of Ground Truth Used

For the mechanical, dimensional, and performance specifications, the ground truth would be based on engineering standards, design specifications, and successful operation within experimental settings (cadaver and animal tissue). For biocompatibility, the ground truth is established by validated laboratory tests (cytotoxicity, sensitization, and irritation or intracutaneous reactivity) against regulatory standards. There is no mention of pathology or outcomes data as a ground truth for the verification and validation reported.

8. Sample Size for the Training Set

This is not applicable as the device is a medical instrument, not an AI/ML algorithm that requires a training set.

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

This is not applicable as there is no training set mentioned for this device.

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