(29 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.
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.
I am sorry, but the provided text does not contain any information about acceptance criteria for a device, a study that proves a device meets acceptance criteria, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set sample sizes and ground truth establishment.
The document is a 510(k) clearance letter from the FDA for a device called "Rapid Programmer, Version 3.3.0" by Advanced Neuromodulation Systems. It establishes the device's substantial equivalence to a predicate device and outlines general regulatory requirements. The "Indications for Use" section describes what the device is intended for, but not how its performance was evaluated against specific criteria.
§ 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).