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The Lac-Mac, Ltd, Innerbloc LR Surgical Gowns are reusable gowns that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

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The provided text is a 510(k) clearance letter from the FDA for a surgical gown. It does not contain any information about acceptance criteria or a study proving that a device meets such criteria.

The document primarily focuses on:

• Confirming the substantial equivalence of the Lac-Mac, Ltd, Innerbloc LR Surgical Gowns to legally marketed predicate devices.
• Outlining the regulatory requirements and responsibilities of the manufacturer.
• Stating the intended use of 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) from this document as it pertains to the evaluation of a medical device's performance against specific metrics.

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