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The EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Fastener is indicated for use in endoluminal, 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 SerosaFuse™ implantable fasteners, and associated EsophyX delivery device and accessories consist of sterile polypropylene fastener implants and an ergonomic, flexible fastener delivery device. The fasteners and delivery devices are provided sterile and are for single use. The polypropylene fasteners are proprietary and function only with the EGS delivery devices. The delivery devices use either a stainless steel helix or suction to grasp tissue and fasten it using the SerosaFuse polypropylene fasteners. The fastener delivery subsystem comprises 3 elements: stylet, pusher, and a lumen. They run the length of the device, the pusher being a hollow tube that rides over the length of the stylet, both riding in the lumen. The stylet is sharp at the distal tip to pierce tissue. The fastener is loaded by snapping it onto the stylet in the loading port of the handle. When pushed by the operator, the stylet carries the fastener down the lumen which runs from the proximal handle assembly to the distal tissue port where it will eventually be deployed into the tissue.

The provided text describes a 510(k) summary for the EndoGastric Solutions (EGS) EsophyX™ System with SerosaFuse™ Fastener and accessories. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size, data provenance, expert adjudication, MRMC study, standalone performance, ground truth establishment, and training set details are not explicitly available in the provided document. The document focuses on device description, intended use, and comparison to predicate devices for regulatory approval based on substantial equivalence.

Here's what can be extracted based on the limitations of the provided document:

1. A table of acceptance criteria and the reported device performance:

• Not explicitly provided. The document focuses on demonstrating substantial equivalence to predicate devices, not on meeting specific, quantifiable acceptance criteria with reported performance metrics from a study.

2. Sample size used for the test set and the data provenance:

• Not provided. The document does not describe a performance study with a test set. It mentions a 510(k) submission which relies on comparison to predicate devices, not typically a new clinical study for performance metrics in the way implied by these questions.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Provided. No specific test set or ground truth establishment by experts is described in the context of this 510(k) summary.

4. Adjudication method for the test set:

• Not applicable/Provided. No test set requiring adjudication is described.

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:

• Not applicable/Provided. This device is an endoscopic tissue approximation/plication system, not an AI-assisted diagnostic device that would typically involve human readers and an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable/Provided. This is a medical device for tissue approximation, not an algorithm.

7. The type of ground truth used:

• Not applicable/Provided. As there is no described performance study for the device against specific criteria, the concept of a "ground truth" for performance evaluation is not detailed.

8. The sample size for the training set:

• Not applicable/Provided. This device is not an AI/algorithm-based system that requires a "training set."

9. How the ground truth for the training set was established:

• Not applicable/Provided. As there is no training set mentioned, this information is not relevant or provided.

In summary, the provided 510(k) summary primarily demonstrates substantial equivalence to existing predicate devices based on intended use and method of operation. It does not detail specific performance studies with acceptance criteria, test sets, or ground truth establishment in the manner typically associated with the evaluation of AI or diagnostic devices.

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