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Master & Frank Surgical Gowns (Sterile) are single use article of 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.

Master & Frank Surgical Gowns (Sterile), is manufactured from non-woven fabric. This surgical Gown is supplied sterile and for single use only.

The provided text is a 510(k) summary for a medical device, specifically Master & Frank Surgical Gowns (Sterile). It outlines the device description, intended use, and a performance summary. However, it does not describe an AI medical device, but rather a physical sterile surgical gown.

Therefore, the requested information regarding acceptance criteria and a study proving a digital device meets those criteria (which would typically involve performance metrics like accuracy, sensitivity, specificity, statistical analysis of a test set, expert adjudication, etc.) is not applicable to this submission.

The "Performance Summary" section of the 510(k) states:

"In terms of Physical specification -- ASTM D1424 , ASTM D5034 & NFPA Flammability standards----etc, Biological specification ISO 10993 series & Sterilization Specification ISO 11137 & ISO 11607-1 , the device are designed to meet applicable standards.."

This indicates that the acceptance criteria for this physical device are based on compliance with established industry standards for physical properties (like tear strength, tensile strength, flammability), biological safety (biocompatibility), and sterilization. The "study" proving it meets these criteria would typically involve bench testing against these specific material and sterilization standards, rather than the types of studies performed for AI software (e.g., test set evaluations with ground truth derived from expert consensus or pathology).

Since the submission is not for an AI device, I cannot provide the requested details regarding AI-specific criteria.

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