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The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

The Axxess® Butterfly Anchor accessory is intended to be used with the ANS Axxess percutaneous permanent and trial leads to secure the leads to the interspinous ligament.

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Axxess® Butterfly Anchor." It primarily addresses the device's substantial equivalence to previously marketed predicate devices and its intended use.

However, this document DOES NOT contain the type of acceptance criteria or details of a study (like an MRMC or standalone study) to prove device performance.

This letter is a regulatory approval document, not a detailed technical report of a performance study. It confirms that the FDA has reviewed the manufacturer's submission and determined that the device is "substantially equivalent" to existing legal predicate devices. This determination is based on the information provided in the original 510(k) submission (K052418), which is not fully included here.

Therefore, I cannot provide the requested information about acceptance criteria and study details from this document. The information you're asking for would typically be found in the manufacturer's original 510(k) submission, specifically in the sections outlining performance testing and clinical data (if any was required for this type of device).

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