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For percutaneous introduction, manipulation, and removal of epidural stimulation leads.

The MedAmicus Epidural Introducer is intended to be used in the same manner as the ANS (Neuromed) Introde INT-8 cleared by the FDA under K930242 and in a similar manner to the Coaxial Dilator manufactured by MedAmicus, Inc. and cleared by the FDA under K990705.

The provided text is a 510(k) submission for a medical device called the "MedAmicus Epidural Introducer." It describes the device, its intended use, and its substantial equivalence to predicate devices, leading to FDA clearance.

Crucially, this document does not include information about acceptance criteria, detailed studies proving device performance, sample sizes for test sets or training sets, ground truth establishment, or expert involvement as described in your request.

The submission focuses on demonstrating substantial equivalence to already cleared predicate devices based on intended use, materials, labeling, method of operation, and manufacturing methods. This type of submission relies on the prior approval of the predicate devices rather than new, extensive performance studies for the new device.

Therefore, I cannot provide the requested information from the given text. The text explicitly states:

"MedAmicus believes the MedAmicus Epidural Introducer is safe and effective based on substantial equivalence to the predicate MedAmicus and ANS Introducer Sheaths. The intended use, materials, labeling, method of operation and manufacturing methods are substantially equivalent."

This indicates that the "proof" for meeting acceptance criteria is the argument of substantial equivalence, not a new clinical or performance study with detailed metrics, sample sizes, or expert panels.

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