Search Results

Medline Medcrest Surgical Gowns are surgical apparel that is intended to be worn by operating room personnel during surgical procedures to help protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Medline Surgical Gowns, non sterile, reusable

I apologize, but the provided text from the FDA 510(k) letter for "Medline Medcrest Surgical Gowns and Surgical Drapes" does not contain information regarding acceptance criteria or a study to prove device performance in the context of an AI/ML powered medical device.

The document is a standard 510(k) clearance letter confirming substantial equivalence to a predicate device for traditional medical devices (surgical gowns and drapes). It mentions general controls, manufacturing practices, labeling, and responsibilities under the Act. It also includes the intended use for the surgical gowns.

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set details) as it is not present in the provided text.

Ask a specific question about this device