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The Urgent PC Neuromodulation System is intended to treat patients with Overactive Bladder (OAB) and associated symptoms of urinary urgency, urinary frequency, and urge incontinence.

The Urgent® PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS). The Urgent PC Neuromodulation System is a combination of the Urgent PC Stimulator and the Urgent PC Stimulation Lead Set. The Urgent PC Stimulator is a battery-operated external pulse generator and is designed, constructed, and manufactured for multiple use, only in conjunction with the Urgent PC Stimulation Lead Set. The Urgent PC Stimulation Lead Set transfers the electrical current from the Urgent PC Stimulator to the tibial nerve via the Needle Electrode. The entire Stimulation Lead Set is intended for single use only and is not to be reused.

The provided text does not contain a study that proves the device meets specific acceptance criteria in the manner requested. The document is a 510(k) premarket notification for the Urgent® PC Neuromodulation System. It highlights that the "new device" is substantially equivalent to a previously cleared predicate device (K071822). The primary difference noted is a change in the wording of the indications statement to incorporate "Overactive Bladder (OAB)" terminology, which is described as an "update in wording rather than a change in the device patient population."

Therefore, the submission relies on the established performance and safety of the predicate device, rather than presenting new clinical study data with specific acceptance criteria and detailed performance metrics for the updated device itself.

Based on the provided information, I cannot complete the requested tables and details as the document does not include a new study with explicit acceptance criteria and corresponding performance data for the device.

Here's an explanation of why the requested information cannot be extracted:

• No explicit acceptance criteria or measured performance: The document states that the "Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use," but it does not provide any specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, or clinical efficacy rates) or reported performance values against those criteria.
• No new study details: The submission is a 510(k) for substantial equivalence, not a new clinical trial reporting primary endpoints and statistical analysis. It does not describe a study involving test sets, ground truth establishment, expert adjudication, or MRMC studies.

In summary, the provided document is a regulatory submission asserting substantial equivalence to a predicate device, and thus does not contain the detailed study information (acceptance criteria, sample sizes, ground truth methodology, etc.) that would typically be found in a clinical study report.

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