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Advanced Neuromodulation Systems, Trial Cable is indicated for the treatment 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 Trial Cable is used as an accessory in the Multiprogram Trial Stimulator System (MTS ™). MTS ™ system is intended to be used with ANS Leads (percutaneous) to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or post operatively for up to a maximum of thirty days.

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This document is a letter from the FDA regarding a 510(k) premarket notification for a device named "Trial Cable." It grants clearance for the device, stating it is substantially equivalent to legally marketed predicate devices.

The letter explicitly does not contain any information about:

• Acceptance criteria or reported device performance for the "Trial Cable."
• Any study conducted to prove the device meets acceptance criteria.
• Sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for any studies.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document primarily focuses on regulatory approval and compliance requirements for the "Trial Cable."

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