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The SJM 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 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 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 document is a 510(k) clearance letter from the FDA for the "Rapid Programmer" device. It does not contain any information about acceptance criteria, device performance tables, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• States the regulation number, name, and class for the device (21 CFR 882.5880, Implanted Spinal Cord Stimulator for Pain Relief, Class II).
• Details general control provisions and additional controls that may apply.
• Provides contact information for compliance and adverse event reporting.
• Includes an "Indications for Use Statement" describing the intended use of the Rapid Programmer in conjunction with the SJM Neurostimulation system for Spinal Cord Stimulation (SCS) in treating chronic trunk and limb pain.

Therefore, I cannot fulfill your request for detailed study information based on the provided text. The document is a regulatory clearance letter, not a study report or technical specification document.

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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.

Ask a specific question about this device

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.

Ask a specific question about this device