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The primaGARD Surgical Drapes are NoNSterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The drapes are made of natural and/or synthetic material and used as a protective patient covering. One example of use of this drape is to isolate the site of surgical incision from particulate, microbial and other forms of contamination.

The primaGARD Surgical Drapes are NoNSterile Surgical Drape, identified in 21 CFR, part 878.4730, as a medical device intended to be used by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material. The drapes are made of natural and/or synthetic material and used as a protective patient covering.

The provided text is a 510(k) premarket notification letter from the FDA to PrimeLine Medical Products, Inc. regarding their Primagard Nonsterile Femoral Angiography Drapes. This document does not contain any information about acceptance criteria or a study proving that the device meets those criteria, as it relates to a device's performance in a clinical or technical sense.

The letter is a regulatory document confirming that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a previously approved device. The "indications for use" statement describes what the device is intended to be used for, but it does not specify performance metrics or study results.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, ground truth types, training set details) from this document because it is not a study report or a technical specification document for the device's performance.

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