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The Surgimatix Absorbable Fixation System is indicated for the approximation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

The Surgimatix Absorbable Fastener System is designed to deliver an absorbable fastener for tissue-to-tissue fixation or mesh-to-tissue fixation during surgical procedures. The deployment device consists of an ergonomic handle with trigger, shaft and tip. The shaft is 38 cm long, and can be utilized for laparoscopic or open surgical procedures. The device is preloaded with 20 polydioxanone absorbable fasteners. During deployment into soft tissue or mesh the absorbable fastener is formed into a helical configuration to establish fixation.

The provided FDA 510(k) summary for the Surgimatix Absorbable Fixation System does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for the type of AI/diagnostic device typically associated with such detailed performance evaluation.

This document describes a medical device (an absorbable fixation system/stapler), not an AI/software as a medical device (SaMD) or diagnostic tool. The "acceptance criteria" and "study" details requested (e.g., sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance) are specific to the validation of AI/ML algorithms or diagnostic tests.

The information provided in the document focuses on:

• Device Description: What the Surgimatix Absorbable Fixation System is and how it works.
• Indications for Use: What the device is intended for (mesh to tissue approximation in hernia repair).
• Predicate Device Comparison: How the Surgimatix device is similar to legally marketed predicate devices (Davol Absorbable Fastener System) in terms of indications, basic components, and function, despite differences in material and fastener deployment mechanism.
• Performance Testing: It mentions "Mechanical, biocompatibility, and preclinical data confirmed that the Surgimatix Absorbable Fixation System performs as intended and that no new issues of safety and effectiveness are introduced." It also states, "The Surgimatix Absorbable Fasteners were tested in vivo in an animal model to confirm the mechanical strength of the repair over time as compared to the predicate device."

Therefore, it is not possible to extract the requested information from this document because it is irrelevant to the type of device being described.

To answer your prompt with the provided document, I would have to state that the information is not present, as the document is a 510(k) summary for a physical medical device (an absorbable stapler), not an AI/diagnostic software.

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