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The SRI/Surgical Express SRI Level III Gowns are reusable gowns that are 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 III Gowns are reusable gowns.

My apologies, but the provided text from the FDA 510(k) clearance letter for the "SRI/Surgical Express Level III Gowns" does not contain the specific information required to answer your request regarding acceptance criteria and a study proving device performance in the context of an AI/ML-driven medical device.

This document is a regulatory clearance letter for a physical product (surgical gowns), not a software or AI device. The information typically associated with studies proving AI device performance (like sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not applicable to this type of traditional medical device.

The letter does contain:

• Trade/Device Name: SRI/Surgical Express Level III Gowns
• Regulation Number: 21 CFR 878.4040
• Regulation Name: Surgical Apparel
• Regulatory Class: II
• Product Code: FYA
• Indications for Use: "The SRI/Surgical Express SRI Level III Gowns are reusable gowns that are 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."
• 510(k) Number: K080707

However, it does not provide any data or details about performance studies in the way you've outlined for an AI/ML device. For a surgical gown, "acceptance criteria" would typically relate to physical properties like barrier protection level (e.g., AAMI Level 3), liquid resistance, tensile strength, sterility, etc., which are usually tested according to recognized standards (e.g., ANSI/AAMI PB70, ASTM F1670, ASTM F1671). The letter states that the device is "substantially equivalent" to legally marketed predicate devices, implying that it meets the same performance standards as those predicates, but it does not detail the specific test results or studies within this document.

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