(30 days)
ANS Lamitrode S-Series (S4 and S8) Leads, models 3243, 3246, 3283 and 3286, 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. Lamitrode S4 and S8 leads are design to be connected to ANS neurostimulation receiver, Models 3408 and 3416, transmitter models 3508 and 3516 and extension models 3341, 3342, 3343, 3346, 3382, 3383 and 3386.
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I am sorry, but the provided text is a 510(k) clearance letter for the Lamitrode S-Series Leads. This document does not contain any information regarding acceptance criteria for device performance, details of a study that proves the device meets those criteria, or any of the specific study parameters you asked about (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).
This document is part of a regulatory filing affirming substantial equivalence to a predicate device, not a performance study report. Therefore, I cannot extract the requested information from this 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).