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The Urgent PC Neuromodulation System is intended to treat patients suffering from 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 document is a 510(k) Pre-market Notification for the Urgent® PC Neuromodulation System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing new clinical study data with specific acceptance criteria and detailed performance metrics as would be found in a PMA (Premarket Approval) application.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them, specifically:

1. A table of acceptance criteria and the reported device performance: This information is not present. The submission states that the new device and the predicate device are "technologically the same" and that the new device "allows for the successful performance of the product's intended use," implying that its performance is equivalent to the predicate, but no specific performance metrics or acceptance criteria are given.
2. Sample size used for the test set and the data provenance: Not applicable, as no new clinical study data is presented for this 510(k).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary from the document:

The Urgent® PC Neuromodulation System (K071822) is being cleared as substantially equivalent to a previously cleared device (Urgent® PC Neuromodulation System, K061333). The basis for this equivalence is that:

• Both devices have the same intended use: to treat patients suffering from urinary urgency, urinary frequency, and urge incontinence.
• They are technologically the same: percutaneous tibial nerve stimulator devices with lead sets, intended to deliver retrograde access to the sacral nerve.
• Both have the same principles of action.
• The only difference is in the Instructions for Use.

The submission concludes that the new device allows for the successful performance of its intended use based on its substantial equivalence to the predicate, implying that the predicate's performance history and regulatory clearance serve as the "proof" for the new device.

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The Urgent PC Neuromodulation System is intended to treat patients suffering from 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 is a 510(k) summary for the Uroplasty, Inc. Urgent® PC Neuromodulation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance metrics. Therefore, many of the requested details about a study proving device performance against acceptance criteria are not available in this document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state acceptance criteria or provide a table of performance metrics for the Urgent® PC Neuromodulation System itself. The submission is a Special 510(k), which typically relies on comparisons to changes made in a previously cleared device. The key acceptance criterion for a 510(k) is demonstrating substantial equivalence to a predicate device.

The "Performance" section explicitly states: "The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use." This is a qualitative statement, not a quantified performance metric.

2. Sample Size Used for the Test Set and Data Provenance:

No test set or associated sample size is mentioned. This submission is a Special 510(k) for a modification to an already cleared device, not a new clinical study. The submission focuses on technological equivalence.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:

Not applicable. No test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set:

Not applicable. No test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a neuromodulation system, not an AI-powered diagnostic device, and no MRMC study is mentioned.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a neuromodulation system, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No ground truth is established as there is no new clinical trial described. The "ground truth" for the 510(k) revolves around demonstrating the device's technological and safety equivalence to its predicate.

8. The Sample Size for the Training Set:

Not applicable. This device is a neuromodulation system, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set is described.

Summary of what the document does communicate:

• Device: Urgent® PC Neuromodulation System, used for percutaneous tibial nerve stimulation (PTNS) to treat urinary urgency, frequency, and urge incontinence.
• Regulatory Pathway: Special 510(k) (K061333).
• Predicate Device: Urgent® PC Neuromodulation System (K052025).
• Key Argument for Equivalence: The new and predicate devices are "technologically the same" with similar intended uses and principles of action. Any differences are stated not to raise concerns about safety or effectiveness.
• Conclusion: The device is substantially equivalent to the previously cleared predicate.

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The Urgent PC Neuromodulation System is intended to treat patients suffering from 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 is a 510(k) premarket notification summary and the FDA's clearance letter for the Uroplasty, Inc. Urgent® PC Neuromodulation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a new product.

Therefore, the document does NOT contain information on:

• A table of acceptance criteria and reported device performance based on a new study.
• Sample sizes used for a test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts or their qualifications for ground truth.
• Adjudication method for a test set.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes data, etc.).
• Sample size for a training set.
• How ground truth for a training set was established.

Explanation Based on Provided Text:

The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (UroSurge® Percutaneous SANS™ Device, K992069). This means the focus is on showing that the new device has the same intended use, technological characteristics, and principles of operation, and that any differences do not raise new questions of safety or effectiveness.

The "Performance" section within the 510(k) summary states: "The Urgent PC Neuromodulation System and Stimulation Lead Set allows for the successful performance of the product's intended use." This is a declarative statement of perceived performance, not a report of a specific study with defined acceptance criteria and quantitative results.

The FDA's decision letter confirms this approach, stating "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

In summary, there is no detailed study described in this document that would provide the requested information regarding acceptance criteria, sample sizes, ground truth establishment, or expert involvement for a performance study. The device's "performance" is implicitly accepted because it is deemed substantially equivalent to a device already cleared by the FDA.

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