(17 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 procedure data. Rapid Programmer 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.
The Rapid Programmer is intended to assist clinicians in determining the optimum performance while automatically logging procedure data. Rapid Programmer 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.
The document you provided is an FDA 510(k) clearance letter for a device called "Rapid Programmer," which is part of an "ANS Neurostimulation system" for Spinal Cord Stimulation (SCS) in the treatment of chronic pain.
This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
FDA 510(k) clearance letters primarily indicate that a new device is "substantially equivalent" to a legally marketed predicate device. They typically refer back to the submission made by the manufacturer. To get the information you're asking for, you would need to review the original 510(k) submission document (K040609) itself, which is usually not publicly available in its entirety in an easily accessible format.
Therefore,Based on the provided document, I cannot fulfill your request as the information is not present.
§ 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).