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Disposable surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the disposable surgical gowns met the requirements for Level 3 classification.

The proposed devices are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and are provided in sterile.

There are two types of disposable surgical gown: standard disposable surgical gown, reinforced disposable surgical gown. And each type of surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for standard and reinforce disposable surgical gown meet AAMI Level 3.

The provided document is a 510(k) Summary for a Disposable Surgical Gown (K212925). It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance testing.

Therefore, the requested information pertaining to acceptance criteria and study proving a device that uses AI meets criteria, specifically including details like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment, is not applicable to this document.

This document details the physical and biological characteristics of a surgical gown and its performance against established standards for protective apparel (e.g., fluid barrier, flammability, strength), not an AI/software as a medical device.

Key takeaways from the document regarding the device's performance and acceptance:

• Device Type: Disposable Surgical Gown, Class II medical device.
• Purpose: To protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures.
• Acceptance Criteria/Performance Standard: The device "met the requirements for Level 3 classification" per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.
• Testing Basis: Primarily non-clinical tests to verify that the proposed device met design specifications and was safe/similar to the predicate device.
• No Clinical Study: The document explicitly states, "No clinical study is included in this submission."
• No AI Component: The device is a physical surgical gown; there is no mention or indication of any AI component, algorithm, or software.

Since the request is about an AI-powered device and this document describes a physical medical device (a surgical gown) with no AI component, a direct answer to the outlined points is not possible based on the provided text.

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