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For temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary.

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This document is a 510(k) clearance letter from the FDA for a device called "STAR Temporary Wound Cover." It primarily deals with the regulatory approval process and doesn't contain information about specific acceptance criteria, study details, or device performance metrics as requested in the prompt. The letter states that the device is "substantially equivalent" to previously marketed devices, but it does not specify the quantitative performance metrics or studies used to demonstrate this equivalence.

Therefore, I cannot provide the requested information from this document. The document primarily confirms regulatory clearance based on substantial equivalence, rather than detailing a specific performance study.

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