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The SRI/Surgical Express SRI LP Drapes are reusable drapes, including back table covers (model numbers 1616, 1822, 3010, 3015, 3020, 3025, 3030, and 6113), mayo stand covers (model numbers 1247C, 3000, 30004, 3006, and 6247A), and drape sheets (model numbers 3870, 3871, 3872, and 3873) that are intended to be used by health care personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Reusable drapes, including back table covers (model numbers 1616, 1822, 3010, 3015, 3020, 3025, 3030, and 6113), mayo stand covers (model numbers 1247C, 3000, 30004, 3006, and 6247A), and drape sheets (model numbers 3870, 3871, 3872, and 3873).

I am sorry, but the provided text does not contain the detailed information needed to fill out the table and answer all the questions regarding acceptance criteria and a study proving device performance.

The document is a 510(k) clearance letter from the FDA for SRI/Surgical Express Level IV Drapes. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not describe the specific acceptance criteria used in a performance study, nor does it provide details about such a study (sample sizes, expert qualifications, ground truth establishment, etc.). It only mentions that the device is subject to general controls and existing major regulations.

Therefore, I cannot generate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based only on the provided text.

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