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AMS Pelvic Floor Repair System is intended for use where the connective tissue has ruptured or for implantation to reinforce soft tissues where weakness exists in the urological, gynecological and gastroenterological anatomy. This includes but is not limited to the following procedures: pubourethral support, including urethral slings for the treatment of incontinence, vaginal wall prolapse repairs including anterior and posterior wall repairs, vaginal suspension, reconstruction of the pelvic floor and tissue repair.

The Apogee and Perigee Systems with IntePro Lite and InteXen LP are sterile, single use procedure kits that consist of stainless steel, curved needle passers and an implantable mesh assembly.

The provided text is a 510(k) summary statement and related FDA correspondence for a surgical mesh device. The document states that the device components were "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." However, it does not provide specific quantitative acceptance criteria or a detailed study description that proves the device meets those criteria.

Therefore, the requested information, which typically involves detailed performance metrics, sample sizes, expert involvement, and ground truth establishment, is not present in the provided text.

Here's a breakdown of why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: The document states "tested for biocompatibility and performance requirements and found to be substantially equivalent to the predicate devices." It does not provide a table with specific criteria (e.g., tensile strength, pore size, elasticity) or the numerical results from these tests.
2. Sample sized used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The testing described is for biocompatibility and performance, not involving human interpretation of medical data where experts would establish ground truth.
4. Adjudication method for the test set: Not applicable for the type of testing described (biocompatibility and performance).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document is about a surgical mesh, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a physical medical device.
7. The type of ground truth used: Not applicable in the context of the described physical device testing. The "ground truth" for material properties would be the established standards or values of the predicate device.
8. The sample size for the training set: Not applicable. This is not a machine learning device.
9. How the ground truth for the training set was established: Not applicable. This is not a machine learning device.

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