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Temporary mesh fixation to the inner surface of the abdominal wall to facilitate the permanent placement, by stapling, of the mesh when used in the standard fixation technique for Laparoscopic Hernia Repair.

Stylet with 16 gauge Cannula, for insertion through a separate incision into the abdominal cavity, in Laparoscopic Hernia Repair, to capture and temporarily hold. with spring retraction, the surgical mesh against the abdominal wall for permanent attachment by stapling. On completion of stapling, the stylet and cannula are advanced to release the mesh, enclose the hook within the cannula and safely remove the Hernia Mesh Stabilizer from the surgical site.

This document is an FDA 510(k) summary for a medical device called the "Hernia Mesh Stabilizer." It describes the device, its intended use, and its substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as per your request.

The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to an already legally marketed device (the predicate device) in terms of intended use, technological characteristics, and safety and effectiveness. It does not typically involve the submission of detailed performance studies against specific acceptance criteria in the same way a Premarket Approval (PMA) application would for a higher-risk device.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to a predicate device, not on specific performance metrics.
2. Sample size used for the test set and the data provenance: No test set or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth is discussed.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable (this device is not an AI/ML algorithm that requires a training set).
9. How the ground truth for the training set was established: Not applicable.

The document states that the Hernia Mesh Stabilizer is substantially equivalent to the GraNee Needle System for Hernia Repair due to similar intended use, entry method, function (capturing and holding surgical mesh), and material (stainless steel for internal body contact surfaces), and being sterile and single-use. This comparison serves as the basis for its market clearance, not a performance study against specific acceptance criteria.

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