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The EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system is indicated for use in endoluminal trans-oral tissue approximation and ligation in the GI tract.

The EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system consist of The Lauvousi. flexible fastener delivery device and sterile polypropylene fastener implants. The unit is provided sterile and is a single use device. The polypropylene fasteners are proprietary and function only with the StomaphyX device. The device uses vacuum to invaginate tissue through a port into a chamber and fasten it using H shaped polypropylene fasteners. The fastener delivery subsystem is comprised of 3 elements: stylet, pusher, and internal lumens. 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.

This document is a 510(k) summary for the EndoGastric Solutions StomaphyX™ endoluminal fastener and delivery system. It describes the device, its intended use, and argues for its substantial equivalence to predicate devices. However, it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.

Therefore, I cannot provide an answer that includes:

1. A table of acceptance criteria and reported device performance
2. Sample sizes for test set and data provenance
3. Number and qualifications of experts for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth for the test set
8. Sample size for the training set
9. How ground truth for the training set was established

The document focuses on mechanical and functional equivalence to predicate devices, rather than clinical performance metrics. It primarily addresses regulatory requirements for a 510(k) submission, emphasizing the physical design, intended use, and comparison to existing marketed devices.

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