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Advanced Neuromodulation Systems Lamitrode Spinal Cord Stimulation Leads are 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 and is intended to be used with Advanced Neuromodulation Systems extensions and/or receivers, transmitters, and antennae. The proposed device modification does not affect the original intended use of the legally marketed device.

Advanced Neuromodulation Systems, Inc.'s Lamitrode Leads are implantable devices consisting of spaced electrodes connected by wires within a cover sheath. These lamitrode leads are introduced into the epidural space via a hemilaminectomy, superior to the spinal segment responsible for pain impulse transmission, and connected to a radio-frequency (RF) receiver or pulse generator.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a spinal cord stimulator lead, focusing on device description, comparison to predicate devices, and non-clinical testing related to material changes. It does not detail specific performance metrics, clinical study design, or results in the context of acceptance criteria.

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