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Atrium ProLite S Mesh is indicated for use in hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material.

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This document is a 510(k) clearance letter from the FDA for the Atrium ProLite S Mesh. It confirms that the device is substantially equivalent to a predicate device for specific indications of use (hernia repair, chest wall reconstruction, traumatic or surgical wounds, and other fascial surgical intervention procedures requiring reinforcement with a nonabsorbable supportive material).

However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter is a regulatory approval based on demonstrating substantial equivalence, not a summary of a performance study with specific metrics and methodologies.

Therefore, I cannot provide the requested information based on the provided text. The document is solely an FDA clearance letter and does not include the details of a performance study.

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