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The Lac-Mac Limited InnerBloc® O.R. Gowns based on the RePeL PLUS™ and GORE® Surgical Barrier Fabric Materials, 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. For manufacturing, processing, or repackaging, these gowns must be reprocessed and packaged.

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.

The provided document is a 510(k) premarket notification letter from the FDA regarding surgical apparel (reusable O.R. gowns). It does not contain information about acceptance criteria, study details, or performance metrics for a device in the context of AI or diagnostic accuracy studies.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance data from a clinical or technical study.

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