(87 days)
The 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 Multiprogram Trial Stimulator System is intended to be used with St. Jude Medical Neuromodulation Division percutaneous trial leads and external test extensions to deliver targeted paresthesia to single or multiple painful sites for trial stimulation either intraoperatively or postoperatively for up to a maximum of 30 days.
The St. Jude Medical Neuromodulation Division neurostimulation systems are indicated for spinal cord stimulation (SCS) in 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.
St. Jude Medical Neuromodulation Division percutaneous leads model numbers 3066, 3161, 3163, 3166, 3169, extension model numbers 3382, 3383, 3341, 3342, 3343, and receiver model number 3408, transmitter model number 3508, and antenna model numbers 1220 and 1230 are also indicated to stimulate electrically peripheral nerves to relieve severe intractable pain.
The MTS™ System (also called the Multiprogram Trial Stimulator) is a multi-programmable device designed to deliver low intensity electrical impulses to nerve structures in the dorsal aspect of the spinal cord. The system consists of an external stimulator, one or two trial cables, and a single or multiple percutaneous trial lead.
The trial stimulator is a battery-powered device that can be worn by the patient and is intended to deliver targeted paresthesia to single or multiple painful stimulation either intraoperatively or post operatively for a maximum of 30 days. The device contains electronic circuitry that combines the function of a receiver and a transmitter and allows the stimulator to be easily programmed to deliver electrical pulses via sixteen output polarities through the trial cable to the implanted lead. The Trial Stimulator communicates via an RS232 port with the Rapid Programmer.
The wide-spaced Quattrode trial and permanent leads are for use in spinal cord stimulation and perioheral nerve stimulation. Each lead consists of a variety of platinum iridium electrodes on the distal end connected by individually insulated wires to platinum iridium contact bands on the proximal end. The insulated wires are covered by a biocompatible polyurethane or silicone rubber sheath. The lead assembly consists of 4 cylindrical electrodes spaced at precise intervals. These leads are designed for introduction into the epidural space using an epidural needle, a guide wire, the optional Introde-AK (Introde) lead introducer, and a stylet to aid in positioning. Also, the permanent wide-spaced Quattrode leads (model #s: 3161, 3163, 3166 and 3169) are designed to be placed directly on or adjacent to a peripheral nerve. The exception is found with the widespaced Quattrode trial leads (model #3066) in that they are used during a trial implantation period not to exceed 30 days.
The inquiry is about a medical device application for St. Jude Medical's MTS™ System and Wide-Spaced Quattrode™ Percutaneous Leads, filed in 2013. However, the provided text does not contain typical acceptance criteria or a detailed clinical study report with performance metrics, sample sizes, or ground truth establishment relevant to AI/ML device evaluations. The document is a 510(k) summary and FDA decision letter for a medical device that predates the common application of AI/ML in medical devices, especially in the context of diagnostic performance studies.
The provided text describes a non-AI/ML device (spinal cord stimulator system) and focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical and clinical evaluations related to a change in contraindication for demand-type cardiac pacemakers to a warning. It does not present a study designed to prove the device's diagnostic or predictive performance against pre-defined acceptance criteria using AI/ML metrics.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML device performance evaluation as the provided text does not contain that information.
§ 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).