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The Sklar Surgical Gown is a single use, sterile or non-sterile item that is intended to be used in the operating room to be a protective covering, for operating room staff, from the transfer of body fluids and particulates.

The Sklar Surgical Gown is a disposable item that is intended to be used in the operating room as a protective covering, for operating room staff, from the transfer of body fluids and particulates.

The Sklar Surgical Gown is provided as sterile and non-sterile.

Sterile gowns are to be sold directly to users following EtO sterilization validation according to ISO 11135-1:2007. Non-sterile gowns are to be sold to OEMs for EtO sterilization according to ISO 11135-1:2007.

The Sklar Surgical Gown is an open back gown manufactured from a non-woven fabric. The non-woven fabric is a polypropylene spunbond meltblown and the fibers are mechanically bonded together. The Surgical Gown comes in various sizes without any areas of reinforcement. The Surgical Gowns are supplied sterile and non-sterile, for single use only.

The provided text describes a 510(k) premarket notification for the "Sklar Surgical Gown." This document focuses on the regulatory submission and approval process for a medical device (a surgical gown), rather than a study evaluating the performance of an AI/ML powered device.

Therefore, the information required to answer the questions about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/ML device is not present in the provided text.

The text includes:

• Device Name: Sklar Surgical Gown
• Classification: Class II, 21 CFR 878.4040, Product Code: FYA (Surgical Apparel)
• Predicate Device: Welmed Inc. Surgical Gowns - K070431
• Device Description: Open back gown from non-woven fabric (polypropylene spunbond meltblown), various sizes, no reinforcement, supplied sterile and non-sterile for single use.
• Indications for Use: "A single use, sterile or non-sterile item that is intended to be used in the operating room to be a protective covering, for operating room staff, from the transfer of body fluids and particulates."
• Regulatory Outcome: Found substantially equivalent to a predicate device.

To answer your request, I would need a document detailing a study specifically designed to evaluate an AI/ML device against acceptance criteria, including performance metrics, data sets, expert review, and statistical analyses.

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