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The Medline Reusable Surgical Gown is intended to be used by operating room personnel du surgical procedures to help protect both the patient and the health care worker from transfer mirco-organisms, body fluids, and particulate material.

Medline Reusable Surgical Gowns (100X)

This document is a 510(k) premarket notification letter for a medical device, specifically Medline Reusable Surgical Gowns. It is not a study report or a technical document detailing the performance of an AI/ML powered device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies or standalone performance cannot be extracted from the provided text.

The document confirms that the FDA has determined the Medline Reusable Surgical Gowns are "substantially equivalent" to legally marketed predicate devices, allowing them to be marketed. This determination is based on the device meeting the existing regulatory framework for surgical apparel (Regulation Number: 878.4040, Product Code: FYA).

The letter does include an "Indications for Use" statement, which typically describes what the device is intended for, but does not provide performance metrics or acceptance criteria in the manner requested for an AI/ML study.

In summary, none of the requested information regarding acceptance criteria and a study to prove device performance (especially in the context of AI/ML) is present in the provided FDA 510(k) letter.

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