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The V.A.C. Abdominal Dressing is a specialty dressing indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary. The Intended Use of this dressing is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome.

The V.A.C. Abdominal Dressing will be provided in a kit to provide an easy, tailored method of applying the dressing in the open abdomen. The V.A.C. Abdominal Dressing is supplied sterile, for single use only, double-pouched and packaged as one kit.

Each V.A.C. Abdominal Dressing kit contains:

• One (1) internal contact laver .
• Two (2) 16 mm outer layer polyurethane open-cell foam pieces .
• Four (4) V.A.C. Drapes .
• One T.R.A.C.TM pad assembly .

The provided text is a 510(k) summary for the V.A.C.® Abdominal Dressing, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific performance metrics and acceptance criteria as would be found for a new diagnostic or AI-driven medical device. Therefore, the information requested in the prompt, such as acceptance criteria, reported performance, sample sizes, expert qualifications, and ground truth establishment, is not available in this document.

The document states:

"Substantial equivalence for the V.A.C. Abdominal Dressing is based on the indications, intended use and technological features."

And also, regarding biocompatibility:

"Material Biocompatibility issues have been addressed based upon biomaterial history. The material used in the KCI V.A.C. Abdominal Dressing are the same materials used for many years in the existing commercially available devices."

This indicates that the device's acceptance was based on its similarity to previously cleared devices in terms of materials, indications, and function, not on a new study demonstrating quantitative performance metrics against specific acceptance criteria.

Thus, I cannot populate the table or answer the specific questions about study details, as these types of studies were not conducted or reported for this 510(k) submission.

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