(90 days)
The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days for:
- Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain;
- Symptomatic relief of post-traumatic pain;
- Symptomatic relief of post-operative pain.
The SPRINT PNS System is not intended to be placed in the region innervated by the cranial and facial nerves.
The SPRINT PNS System is comprised of one or two percutaneous electrodes placed via introducer needles in proximity to target peripheral nerves associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode(s). The SPRINT PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, flexible, coiled, stainless steel wire designed to be percutaneously inserted and remain indwelling for the duration of the therapy (up to 60 days). The Pulse Generator and accessory components provide tools for percutaneous MicroLead placement, system programming by the clinician, and system use by the patient.
The provided document is a 510(k) summary for the SPRINT Peripheral Nerve Stimulation (PNS) System. It describes the device, its intended use, and its comparison to a predicate device. However, this document does not contain any information about acceptance criteria or a study proving the device meets specific performance criteria in the context of an AI/ML medical device.
The document states: "No clinical performance data were included in support of this submission." This means that the submission for clearance of the SPRINT PNS System did not rely on clinical data to demonstrate its performance against specific acceptance criteria. Instead, it relied on nonclinical performance testing and the substantial equivalence to a previously cleared predicate device.
Therefore, I cannot fulfill your request for the information outlined in bullet points 1 through 9, as it is not present in the provided text. The SPRINT PNS System, as described, is a physical device (electrical stimulator) and is not an AI/ML medical device that would typically have acceptance criteria related to accuracy, sensitivity, specificity, and the types of studies you are asking about (e.g., MRMC studies, ground truth establishment by experts, training/test sets).
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).