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Bard® 3DMax™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, in the repair of inguinal hernias.

The Bard® 3DMax™ Mesh is anatomically designed to fit the inquinal anatomy. The device is curve shaped and preformed with sealed edges that allow for easier positioning of the device than a traditional flat sheet of mesh in a laparoscopic inguinal hernia repair. The device is constructed of knitted polypropylene monofilaments 7.5 millimeters in diameter. The knit construction allows the mesh to be stretched in both directions in order to accommodate and reinforce tissue defects. The device contains an orientation marker in an M shape with an arrow to facilitate mesh positioning and placement.

This submission, K233402, describes a Special 510(k) for the Bard 3DMax Mesh, which focuses solely on labeling changes to align with European medical device regulations and other devices in the Davol Inc. portfolio. The submission explicitly states:

"No non-clinical or clinical testing was provided in support of this Special 510(k)." and "The purpose of this Special 510(k) is to notify FDA of the changes to the Bard® 3DMax™ Mesh labeling. There are no changes to the device itself."

Therefore, based on the provided document, there are no acceptance criteria or studies associated with this specific submission to describe regarding device performance, as the device itself (materials, design, manufacturing, etc.) has not changed from its predicate, K081010.

To provide the requested information, one would need access to the original 510(k) submission (K081010) that established the substantial equivalence of the device itself, rather than just its labeling.

Since the prompt asks for information from the provided input, and the input explicitly states no testing was done, I cannot fulfill the request for acceptance criteria and study details.

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