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The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.

The GFX Nerve Ablation System provides a minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve. The Generator and probe are used as a system to both stimulate the nerve for the purpose of locating the probe correctly and to create a neural lesion to inhibit nerve function through the application of RF energy. The GFX Nerve Ablation probes are single use devices supplied sterile to the customer.

The provided text is a 510(k) summary for the GFX Nerve Ablation System. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, this document does not contain the detailed information required to answer your specific questions about acceptance criteria and the comprehensive study proving the device meets those criteria.

The "Summary of Testing" section (Section 6) simply states: "Device integrity and functionality were verified and/or validated using samples produced under routine manufacturing conditions." This is a very high-level statement and does not provide any of the specifics requested.

Therefore, I cannot populate the table or answer the specific questions because the necessary data is not present in the provided document.

To answer your request, I would need a different type of document, such as a detailed study report or a more comprehensive technical file submission, which would outline the specific tests performed, their acceptance criteria, results, sample sizes, ground truth establishment, and statistical analyses.

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The Lesion Probe and Generator system is intended to create radiofrequency (RF) heat lesions in nerve tissue. It is intended for use only by trained clinicians in a hospital or clinical setting.

The GFX Nerve Ablation System provides a minimally invasive technique for creating a neural lesion inhibiting the function of the target nerve. The Generator and probe are used as a system to both stimulate the nerve for the purpose of locating the probe correctly and to create a neural lesion to inhibit nerve function through the application of RF energy. The GFX Nerve Ablation probes are single use devices supplied sterile to the customer.

Here's a breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantitative acceptance criteria or detailed performance metrics from a clinical study. Instead, it relies on a comparison to predicate devices and bench testing to demonstrate substantial equivalence.

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

The document does not describe a clinical test set in the traditional sense, such as a cohort of patients for an effectiveness or safety study. The "test set" from a regulatory perspective here refers to:

• Bench Testing Samples: Devices produced under routine manufacturing conditions. The exact quantity of samples is not specified.
• Biocompatibility Testing Samples: Not specified, but implied to be sufficient for meeting ISO standards.
• Sterilization Validation Batches: Not specified, but implied to be sufficient for meeting ISO standards.

The data provenance for these tests is internal to ACI Inc. and would be considered retrospective in the sense that they are internal validation tests, not a forward-looking clinical trial. There is no mention of country of origin for any human data, as no human data is presented for performance evaluation.

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

This information is not applicable or provided in the document. No clinical test set with human data requiring expert ground truth establishment for a diagnostic or AI-assisted system is described. The device is a direct treatment tool, and its "performance" is assessed through engineering and bench testing, not expert interpretation of outputs.

4. Adjudication Method for the Test Set

This is not applicable or provided. There is no clinical test set requiring human adjudication of results.

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

No, an MRMC comparative effectiveness study was not done and is not described in this document. The device is a therapeutic radiofrequency ablation system, not an imaging or diagnostic aid that would typically involve human readers.

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

This is not applicable. The GFX Nerve Ablation System is a physical device (generator and probe) that creates heat lesions. It is not an algorithm, software, or AI system that operates in a "standalone" or "human-in-the-loop" capacity in the way an AI diagnostic tool would. Its performance is evaluated based on its physical and electrical characteristics and ability to produce lesions, as demonstrated through bench testing and comparison to predicate devices.

7. The Type of Ground Truth Used

For the bench testing and validation, the ground truth would be based on:

• Engineering specifications and standards: For RF energy output, temperature control, impedance monitoring, etc. (e.g., meeting specific voltage, current, and temperature targets).
• Biocompatibility standards: (ISO 10993 series for material safety).
• Sterilization efficacy standards: (ISO 11135 for sterility assurance).
• Physical integrity standards: For packaging and device robustness.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this type of device submission's performance evaluation.

8. The Sample Size for the Training Set

This is not applicable. The GFX Nerve Ablation System is not an AI or machine learning device. It does not have a "training set" in the context of algorithm development.

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

This is not applicable as there is no training set for an algorithm.

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