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The SPRINT Peripheral Nerve Stimulation (PNS) System is indicated for up to 60 days in the back and/or extremities 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 treat pain in the craniofacial region.

The Sprint PNS System is comprised of a percutaneous electrode placed via an introducer needle in proximity to a target peripheral nerve associated with a painful area and a wearable external Pulse Generator (stimulator) that delivers stimulation therapy to the percutaneous electrode. The Sprint PNS System provides peripheral nerve stimulation (PNS) therapy to relieve pain. The percutaneous electrode (MicroLead) is a sterile, coiled, stainless steel wire designed to be percutaneously inserted via an introducer needle 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, stimulator programming by the clinician, and stimulator use by the patient.

The provided documents do not contain information about acceptance criteria and a study proving a device meets those criteria, specifically concerning AI/algorithm performance metrics, sample sizes for test/training sets, expert qualifications, or multi-reader multi-case studies.

The documents are a 510(k) premarket notification for the SPRINT Peripheral Nerve Stimulation System, which describes a medical device for pain relief, its comparison to a predicate device, and the non-clinical testing performed. It focuses on demonstrating substantial equivalence to a previously cleared device, based on similar indications for use and technological characteristics, rather than establishing performance against specific acceptance criteria through clinical studies involving human readers or AI algorithms.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets, or data provenance.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods for test sets.
• MRMC comparative effectiveness study details (effect size of AI assistance).
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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