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The Lac-Mac, Limited, InnerBloc® LR Surgical Gowns, based on the GORE® LR Fabric, are reusable gowns that are intended to be worn by health care personnel during surgical and other medical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.

reusable gowns that are intended to be worn by health care personnel during surgical and other medical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

This document is an FDA 510(k) clearance letter for a surgical gown, not a study report for a medical device that uses AI or performs diagnostic tasks that would typically require acceptance criteria based on performance metrics like sensitivity, specificity, etc.

Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, as it relates to performance metrics for a diagnostic or AI-driven device.

The document is a regulatory approval for a physical product (surgical gowns) based on substantial equivalence to a predicate device, which focuses on manufacturing, materials, and intended use as defined by existing regulations. It does not involve performance studies with test sets, ground truth, expert adjudication, or MRMC studies.

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