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The Sterile Triplex Surgical Gown (S, M, L, XL, XXL, is a sterile single-use surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

They have been tested and are classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities.

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This document is a 510(k) premarket notification letter from the FDA regarding a Sterile Triplex Surgical Gown. It clears the device for marketing due to its substantial equivalence to legally marketed predicate devices.

The information provided in the document is about the regulatory clearance for a physical medical device (surgical gown) based on its performance in barrier tests, not an AI/ML medical device. Therefore, the questions about acceptance criteria for an AI/ML model, test sets, ground truth establishment, expert adjudication, MRMC studies, and training sets are not applicable to this document.

The document states:

• Trade/Device Name: Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL)
• Regulation Number: 21 CFR 878.4040
• Regulation Name: Surgical Apparel
• Regulatory Class: Class II
• Product Code: FYA
• Indications for Use: To protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
• Performance Claim: "They have been tested and are classified as Level 4 in the critical zones per AAMI Standard PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities."

Since the request is specifically about a study proving device performance using AI/ML-related metrics, and this document pertains to a physical sterile gown, I cannot extract the requested information.

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