(183 days)
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.
| Acceptance Criteria (Not explicitly stated as quantitative targets) | Reported Device Performance |
|---|---|
| Technological Substantial Equivalence to Predicate Devices: | |
| - Indications For Use | Substantially equivalent |
| - RF Energy Output Type (Frequency, Power, Wave Type) | Substantially equivalent |
| - Treatment Time | Substantially equivalent |
| - Functions (stimulation and ablation) | Substantially equivalent |
| - Safety Monitoring Systems (Temperature, Impedance, Power Output) | Substantially equivalent |
| - Probe Type (single use) | Substantially equivalent |
| Biocompatibility: | Meets ISO 10993-1, AAMI/ISO 10993-7 |
| Sterilization: | Meets ISO 11135 |
| Packaging: | Validated and 100% visual verification for integrity |
| Device Integrity and Functionality: | Qualified/validated using routine manufacturing samples; meets ACI Inc.'s in-house requirements. |
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.
§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(b)
Classification. Class II (performance standards).