(60 days)
Advanced Neuromodulation Systems, MTSm Multiprogram Trial Stimulator System 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 MTSm Multiprogram Trial Stimulator System is intended to be used with ANS Trial Leads (percutaneous) and External Test Extensions, 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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Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for the test set
- Number and qualifications of experts for ground truth
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- MRMC comparative effectiveness study results
- Standalone performance study
- Type of ground truth used
- Sample size for the training set
- Method for establishing ground truth for the training set
§ 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).