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The SRI Level II Surgical Gown is a reusable surgical gown intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

SRI Level II Surgical Gown SRI Part Numbers of various sizes: 7001, 7002, 7003, 7004, 7005

The provided text is a 510(k) premarket notification letter from the FDA regarding a SRI Level II Surgical Gown. This document is a regulatory approval for a medical device and does not contain the kind of detailed study information (like acceptance criteria, sample sizes, expert qualifications, or multi-reader multi-case studies) that would typically be found in a performance study report for AI/machine learning medical devices.

Therefore, I cannot extract the information required by your prompts from this document. The document primarily focuses on regulatory approval based on "substantial equivalence" to previously marketed devices, rather than a detailed performance study with quantifiable metrics as typically seen in AI device approvals.

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