(63 days)
Advanced Neuromodulation Systems Tripole 8C, Tripole 16C, and Exclaim 8 Lead Kits are indicated for 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 and are intended to be used with Advanced Neuromodulation Systems receivers, transmitters, and/or antennae.
Not Found
I apologize, but this document, which appears to be an FDA 510(k) clearance letter, does not contain the information requested about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for an AI/device study.
This document is a regulatory approval letter for a medical device called "Lamitrode Series Leads" (spinal cord stimulators). It confirms that the devices are substantially equivalent to previously marketed devices and can be marketed. It discusses regulatory requirements, classifications, and general controls.
The information you are requesting would typically be found in the summary of safety and effectiveness data or the clinical study report that would have been submitted as part of the 510(k) application, but those detailed study documents are not present in the provided text.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, study design, and performance metrics based on the provided text.
§ 882.5880 Implanted spinal cord stimulator for pain relief.
(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).