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The SRI/Surgical Express SRI Level IV Gowns are reusable gowns that arc 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/Surgical Express Level IV Gowns

The provided text is a 510(k) premarket notification letter from the FDA regarding a surgical gown (SRI/Surgical Express Level IV Gowns). This document is a regulatory approval letter and does not contain the information requested in your prompt regarding acceptance criteria, study details, or AI performance metrics.

Therefore, I cannot extract the following information from the given text:

• Table of acceptance criteria and reported device performance
• Sample size and data provenance for the test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study details or effect size
• Standalone algorithm performance
• Type of ground truth used
• Sample size for the training set
• Ground truth establishment for the training set

This document is solely focused on the FDA's determination of substantial equivalence for a physical medical device (surgical gowns) based on existing predicate devices and general controls, not on the performance of a software or AI-based device.

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