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Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain.

The PNT Control Unit is to be used with PNT Lumbar Safeguides for low back pain or PNT Cervical Safeguides for neck and/or upper back pain.

The Vertis PNT System is designed for delivering percutaneous electrical stimulation (termed: Percutaneous Neuromodulation Therapy -PNT ). The Vertis PNT System is intended to be used in pain management by a physician (e.g., anesthesiologists or physical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. The device system includes 3 major components:

• the Vertis PNT Control Unit a software-driven, ● five channel, AC powered nerve stimulator which generates the electrical stimulus;
• the sterile Safeguides which are sterile, needle electrodes; ●
• the Patient Cable - which interconnects the PNT Control Unit to the electrodes

The provided text describes a 510(k) submission for a modification to an existing device, the Vertis Percutaneous Neuromodulation Therapy (PNT) System. The submission is specifically to request clearance for a new cervical electrode kit and cable and to update the labeling.

The document states that "Extensive data were provided that evaluated the use of PNT cervical electrodes and cervical percutaneous electrical stimulation. These data included the following. Data demonstrated acceptable results for the device and therapy." However, it does not provide explicit acceptance criteria, thresholds for device performance, or detailed results beyond stating that they were "acceptable."

Therefore, I cannot populate the table of acceptance criteria and reported device performance as requested. Similarly, the study itself is not described in enough detail to answer many of the subsequent questions.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified.
• Data Provenance: The document mentions "published human clinical trial data for cervical pain management" and "post-market data for the Vertis PNT System." This suggests a combination of prospective clinical study data and retrospective post-market surveillance. The country of origin is not specified, but the applicant company is based in Seattle, Washington, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not specified. The data includes "human magnetic resonance images (MRI)/ computerized tomography (CT) imaging data," which would typically involve expert interpretation, but the number or qualifications of these experts are not provided.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not specified.

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. The device is a nerve stimulation system, not an AI-powered diagnostic imaging tool that would typically involve human readers.

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

Not applicable. This is a medical device (nerve stimulator) that requires human operation and interaction with a patient, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the nature of the device (pain management), the "published human clinical trial data for cervical pain management" likely relied on patient-reported outcomes data (e.g., pain scales, functional assessments) as the primary ground truth for efficacy. The "post-market data" would also likely include outcomes data and adverse event reporting. "Electrode performance and dimensional (bench) data" and "MRI/CT imaging data" would have engineered or expert-evaluated ground truths, respectively, but these relate to device safety and characteristics rather than clinical efficacy.

8. The sample size for the training set

Not specified. This device is a hardware system, not a machine learning algorithm, so the concept of a "training set" in the context of AI does not directly apply. If "training set" refers to data used in the design or optimization of the device, it is not detailed.

9. How the ground truth for the training set was established

Not applicable. See explanation for question 8.

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