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

The PNT Control Unit is to be used with a PNT Safeguide Kit - Lumbar.

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., I NT Uystein is intendousical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. It is not intended for patient use. 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, and ●
• the Patient Cable which interconnects the PNT Control Unit to the . electrodes

The provided text describes the Vertis Neuroscience, Inc. Percutaneous Neuromodulation Therapy (PNT)™ Control Unit and Accessories, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present specific quantitative acceptance criteria (e.g., minimum accuracy, sensitivity, or specificity thresholds) for device performance as would typically be seen in AI/diagnostic device submissions. Instead, acceptance is framed around adherence to electrical safety, quality management, and biocompatibility standards, and demonstrating overall safety and effectiveness through a clinical trial.

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

• Sample Size for Clinical Test Set: 215 patients.
• Data Provenance: The clinical trial was a prospective study conducted at "multiple United States clinical sites."

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

The document does not specify the number or qualifications of experts involved in establishing ground truth for the clinical trial. It only states that the system is intended for use by a physician (e.g., physical medicine and rehabilitation physicians) or on the order of a physician (e.g., physical therapist). The clinical trial "demonstrated the safety and effectiveness," but the method of assessing patient outcomes or 'ground truth' for effectiveness (e.g., pain reduction scales, functional improvement) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the clinical test set. It mentions the trial was "reviewed and approved in November 2000" and that Vertis "conducted a prospective clinical study evaluating the safety and effectiveness."

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not indicated in the provided text. The device is a nerve stimulation system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting cases with and without AI assistance. This study focused on the safety and effectiveness of the therapy itself.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable in the typical sense for this device. The PNT System is a physical device (control unit, electrodes, patient cable) that delivers electrical stimulation. It is not an algorithm that performs a diagnostic task in a standalone manner. Its "performance" is in generating the electrical stimulus and the clinical outcome from that stimulation, which is inherently human-in-the-loop (physician application to the patient). The software component was validated, but this likely refers to its control functions, not independent diagnostic performance.

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

The document does not explicitly state the type of "ground truth" for the clinical effectiveness. Given the nature of a therapy for pain management, it is highly probable that the effectiveness was assessed using patient-reported outcomes data (e.g., pain scales, functional questionnaires) and clinician observations, rather than pathology or expert consensus on a diagnostic finding. The safety aspect would be based on adverse event reporting.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here as the device is not an AI/machine learning model in the sense that it learns from a dataset. It is a therapy delivery system. The clinical trial data (215 patients) would be considered the "test set" for validating its performance in a clinical setting.

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

This question is not applicable as there is no "training set" for an AI model described for this device.

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