(57 days)
The ANS Neurostimulation system is indicated for Spinal Cord Stimulation (SCS) in the treatment of chronic pain of trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach.
The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedures data. Rapid Programmer also allows the clinician to optimize performance by leading the patient through a series of device parameter combinations and recording the stimulation effects. This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
This system uses a touch screen computer to program the stimulator to the required waveforms and electrode configurations and to log the information derived.
The provided text is a 510(k) clearance letter from the FDA for the "Rapid Programmer" device. It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter confirms substantial equivalence of the device to a predicate device for its stated indications for use, but it doesn't detail performance metrics, study designs, or ground truth establishment.
Therefore, I cannot extract the requested information from 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).