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3L. Surgical Drapes described in this submission are intended to be used to provide an isolating barrier during surgical procedures. The drapes cover the patient and are made of plastic with a protective film that stops fluid strike-through.

The drapes submitted provide an isolator as a vertical barrier to keep the C-arm from the surgical field during hip/femur fracture or trauma procedures, or create a isolating barrier during orthopedic procedures, or provide secure adhesion on drapes for general use, or meet surgical minor procedural needs, or give a sterile surface all of the way to the wound.

3L® Surgical Drapes are made from PE or PU sheets with adhesive strips, sterilized or nonsterilized. They provide an isolating barrier during surgical procedures to cover the patients and stops fluid strike-through.

The provided text describes a 510(k) premarket notification for a medical device, specifically 3L® Surgical Drapes. It does not contain information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert involvement, or ground truth establishment for a diagnostic or AI-driven device.

The document states that the 3L® Surgical Drapes are "generally identical to 3M™ Surgical Drape in design, material, specifications and intended use" and that "Physical and biological tests were performed in accordance with industry recognized test methods." However, the details of these tests, including specific acceptance criteria and the results, are not present in the provided excerpts.

This submission is for a Class II medical device (Surgical Drape), and the FDA's decision is based on substantial equivalence to a predicate device (3M™ Surgical Drape, K031287), not on a study demonstrating clinical performance against predefined acceptance criteria in the manner one would see for a diagnostic or AI product.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, experts, ground truth, or an MRMC study for an AI device based on the given text. The information required for those points is not contained within this 510(k) summary.

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