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The Medical Surgical Gowns 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 Medical Surgical Gowns met the requirements for Level 3 classification.

The proposed device is a poly-reinforced surgical gown, the critical zone is front chest and sleeves. The critical zone is reinforced with PP/PE composite laminated material and the reinforced layer is attached with the gown by ultrasonic welding. The proposed device is available in five different sizes, include S-160, M-165, L-70, XL-175, XXL-180, and XXXL-185. Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the proposed devices can meet the requirements for Level 3 classification. The proposed devices are disposable medical devices and provided in sterile.

This document is a 510(k) Pre-market Notification for a medical device, specifically Medical Surgical Gowns. The information provided does not describe an AI medical device or a study involving human readers.

Therefore, most of the requested points are not applicable. I can only extract information related to the performance of the Medical Surgical Gowns based on the provided text.

Here's a summary of the information that is available:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are generally based on the ANSI/AAMI PB70:2012 Level 3 classification for liquid barrier performance, along with specific physical and biological properties.

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Disposable gowns are worn by operating room personnel during surgical procedures to protect both the surgical patient and OR personnel from the transfer of body fluids and particulate material.

Gowns are provided as sterile and non-sterile.

Non-sterile surgical gowns are to be sold to OEMs, which require EtO sterilization according to the ISO 11135 standard. Sterile surgical gowns are to be sold directly to users and must be sterilized by an EtO cycle validated to ISO 11135 standard.

Not Found

The provided document is a 510(k) premarket notification letter for a medical device (Jiehong Medical Surgical Gown). This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document primarily focuses on:

• Substantial equivalence determination for a physical product (surgical gown).
• Regulatory classifications and requirements.
• Indications for Use for the surgical gown.
• Material, gown style, sterility, sizes, and model numbers of the surgical gowns.

In summary, this document cannot be used to answer the questions you've posed about acceptance criteria and device performance studies related to AI/ML devices.

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