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The biocompatible ScanTac Membrane or Pad will be used during medical diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics by being affixed to the active element of the transducer. The pad is biocompatible, sterile, and, being solid, leaves no residue. It will be used for transcutaneous ultrasound imaging over surgical wounds, during transcutaneous biopsy and to enhance acoustic coupling to difficult geometries. The pad is sufficiently adherent to remain in place during the procedure. The pad is placed onto the patient, and is a hydrogel. The exposed side of the hydrogel pad will be rendered lubricous with an application of ultrasound coupling sterile fluid, including ScanLube™, water or saline.

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The provided text is an FDA 510(k) clearance letter for a device called "ScanTacTM Pad." This document does not contain the information requested about acceptance criteria and the study proving device performance.

The letter is a notification of substantial equivalence for marketing the device. It focuses on regulatory classifications, general controls, and compliance requirements, rather than detailed performance study results.

Therefore, I cannot provide the requested table and information based on the given input.

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