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ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.

The Cinch™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supraspinous ligament.

The Cinch™ anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supraspinous ligament.

The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for the Advanced Neuromodulation Systems (ANS) Cinch Anchor Model 1194. This type of document declares that a new device is substantially equivalent to a legally marketed predicate device, meaning it does not require a new premarket approval (PMA) and can be marketed subject to general controls.

This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the questions asked. The 510(k) process primarily relies on demonstrating substantial equivalence to a predicate device, often through design and technological characteristics, and sometimes through performance testing if the new device has different technological characteristics that raise new questions of safety and effectiveness. However, the details of such performance testing, if conducted, are not part of this clearance letter.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them based on the provided text. The document is strictly an FDA clearance letter and does not include the detailed study information required.

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