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The EndoGastric Solutions StomaphyXTM system with SerosaFuse™ Fastener is intended for tissue approximation, ligation and full-thickness plication in the G.I. tract.

The EndoGastric Solutions StomaphyX™ Delivery Device and Implantable Fasteners consist of an ergonomic, 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 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.

The provided text is a 510(k) summary for the EndoGastric Solutions StomaphyX Delivery Device, Fasteners and Accessories. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a performance study.

Therefore, the document does not contain the acceptance criteria or the details of a study that proves the device meets specific acceptance criteria in the manner requested.

The 510(k) summary states:

• "Based upon the intended use, descriptive information, and performance evaluation provided in this pre-market notification, the EndoGastric Solutions StomaphyX™ system with SerosaFusc ™ Fastener has been shown to be substantially equivalent to currently marketed predicate devices."

This indicates that the submission relies on demonstrating similarity to existing devices, rather than presenting a performance study with defined acceptance criteria for a new clinical performance claim.

Specifically, the document does not include information on:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance for such a study.
3. Number of experts, their qualifications, or adjudication methods for ground truth establishment.
4. A multi-reader multi-case (MRMC) comparative effectiveness study.
5. A standalone (algorithm only) performance study.
6. The type of ground truth used in a performance study (as no such study is detailed).
7. Sample size for a training set (as no AI/algorithm training is implied).
8. How ground truth for a training set was established.

The document's purpose is to establish substantial equivalence for market clearance, not to report on a clinical performance study with specific acceptance criteria that would typically be seen for a new or novel device's functional performance claims.

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