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The NeuroOne OneRF® Trigeminal Nerve Ablation System is indicated for use in procedures to create radiofrequency lesions for the treatment of pain, or for lesioning nerve tissue for functional neurosurgical procedures.

OneRF® Ablation System for Trigeminal Nerve (TN) Ablation uses radiofrequency (RF) ablation to create lesion(s) in an area of nerve tissue that the surgeon has identified for ablation. The ablation site may be identified by diagnostic stimulation of the trigeminal nerve using the Trigeminal Nerve Radiofrequency (TN-RF) Probe to accurately locate the target area for ablation.

The subject device is identical to the sEEG-RF Probe cleared after FDA review of K231675. In K231675, the FDA reviewed and cleared the sEEG-RF Probe when used with the NeuroOne OneRF® Generator to form the OneRF® Ablation System. The OneRF® Ablation System is indicated to create radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

In this new 510(k), we propose to market the identical sEEG-RF Probes to create lesion(s) in the trigeminal nerve "for the treatment of pain." This use for treatment of facial pain requires new accessories (Cannula and Tuohy Borst Adapter) for insertion/placement of the sEEG-RF Probe. When the sEEG-RF Probe is used to create lesion(s) in the trigeminal nerve, it will be marketed as the Trigeminal Nerve Radiofrequency (TN-RF) Probe. The TN-RF Probe and new accessories, when combined with the cleared (K231675) NeuroOne OneRF® Generator and accessories, will be referred to as the OneRF® Trigeminal Nerve Ablation System.

The OneRF® for TN Ablation System components/accessories consist of the following:

1. TN-RF Probe (with Stylet)
   • 16mm x 5 Contact TN-RF Probe Kit
   • 26.5mm x 8 Contact TN-RF Probe Kit
2. Insertion Components
   i. Insulated Cannula w/Stylet
   ii. Tuohy Borst Adapter (Adapter)
3. Stimulation Components
   i. Cable Assembly (5 or 8 connector pins) (CA)
4. Ablation Components
   i. Stylet
   ii. Temperature Accessory (TA)
   iii. Spacer Tubes
   iv. Radiofrequency Connector Box (RFCB)
   v. Equipment
   1. Generator
   2. Generator Interface Cable (GIC)
   3. Cart
   4. Foot Pedal (optional)
   5. Ground Pad

The provided document is a 510(k) Clearance Letter for a medical device. It does not describe a study that uses a test set, training set, or ground truth to evaluate algorithm performance. The clearance is based on the substantial equivalence of the "NeuroOne OneRF Trigeminal Nerve Radiofrequency Probes" to existing predicate devices, supported by non-clinical performance tests and biocompatibility assessments.

Therefore, I cannot provide the requested information in a table format as there are no relevant acceptance criteria or reported device performance metrics for an AI/algorithm-based study within the document.

Here's why each of your requested points cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document focuses on performance testing related to mechanical, dimensional, packaging integrity, and sterilization aspects of the physical device, not an AI algorithm's performance. The "Lesion Size Testing" states "Lesion sizes were proportional to time and temperature. Lesion size is comparable to predicate," but it doesn't provide specific quantitative acceptance criteria or detailed numerical results beyond this qualitative statement.
2. Sample size used for the test set and the data provenance: Not applicable. The studies are non-clinical, involving physical device testing, not data analysis on a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for a test set in these non-clinical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 is not an AI-assisted diagnostic or interpretative device.
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 (expert consensus, pathology, outcomes data, etc): 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 of available information regarding performance testing:

The document outlines a series of non-clinical performance tests to support the substantial equivalence claim. These tests primarily verify the physical and functional integrity of the device and its components.

• Lesion Size Testing:
  • Overview: Measured lesion size as a function of temperature and time, for monopolar and bipolar configurations, and temperature control/manual modes.
  • Results: "Lesion sizes were proportional to time and temperature. Lesion size is comparable to predicate." (No specific numerical data or explicit acceptance criteria provided in the summary).
• Dimensional Verification of the Cannula:
  • Overview: Evaluated dimensional characteristics and compatibility between components.
  • Results: "Pass – The test results indicate that the Cannula meet the dimensional requirements."
• Mechanical Performance:
  • Overview: Verified specifications related to mechanical interaction between the TN-RF Probe, Cannula, and Tuohy Borst Adapter.
  • Results: "Pass – The test results indicate that the TN-RF Probe, Cannula, Tuohy Borst Adapter designs meet the mechanical performance requirements."
• Mechanical Integrity:
  • Overview: Evaluated mechanical integrity of the TN-RF Probe, Cannula, and Tuohy Borst Adapter.
  • Results: "Pass - The test results indicate that the TN-RF Probe, Cannula and Tuohy Borst Adapter designs meet the mechanical integrity requirements."
• TN-RF Probe Kit Package Integrity:
  • Overview: Tested the packaged device and labeling against conditions of packaging, shelf life, and distribution per ISO 11607-1, ISTA 3A, ASTM D4169, ASTM F1980, ASTM F2096, ASTM F88.
  • Results: "Pass - The test results indicate that the TN-RF Probe Kit (...) packaging designs meet the integrity requirements (i.e., seal strength, bubble leak, label inspection, and no damage that impacts device sterility)."
• Sterilization:
  • Overview: Validated ethylene oxide sterilization process to achieve a minimum SAL of 10⁻⁶ per ISO 11135.
  • Results: "Pass – All criteria passed and the new product/package configuration was adopted into the validated sterilization cycle."
• Usability – Summative Validation:
  • Overview: Performed in accordance with FDA guidance, "Applying Human Factors and Usability Engineering to Medical Devices," February 3, 2016.
  • Results: "Pass – The NeuroOne OneRF® TN-RF Ablation System has been found to be safe and effective for the intended users, uses, and use environments."
• Biocompatibility:
  • Overview: Tested sEEG-RF Probe for prolonged contact and Cannula w/stylet, Tuohy Borst Adapter for limited contact.
  • Results: "Passed" for all tested components. No testing for Temperature Accessory/Spacer Tubes/Stylet and Radio Frequency Connector Box as there is no direct or indirect patient contact.

The provided document specifically clarifies that the device is substantially equivalent, and the "conclusions drawn from the nonclinical testing demonstrate the device is as safe, as effective, and performs as well as the legally marketed device predicates, per 21 CFR 807.92(b)(3)." This is a traditional medical device clearance, not an AI/ML-driven software clearance.

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The NeuroOne OneRF Radiofrequency Ablation System is indicated for creation of radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

The OneRF™ Ablation System components consist of the:

• Radiofrequency (RF) Generator and Accessories
• Generator Interface Cable (GIC), Cart and Foot Pedal (optional)
• sEEG-RF Probe (with Universal Cable Assembly) and Ablation Accessories
• Temperature Accessory, Spacer Tubes, Stylet and RF Connector Box

The OneRF™ Ablation System uses radiofrequency ablation to create lesion (s) in an area of nervous tissue that the neurosurgeon has identified for ablation. This is accomplished by diagnostically locating the area to ablate using the implanted Stereoelectroencephalography (sEEG). Once the area of ablation is located, the generator and ablation accessories are taken to the patient with implanted sEEG(s). The sEEG(s) now function as an sEEG-RF Probe for RF ablation.

To perform the ablation the Temperature Accessory (TA) is inserted into the sEEG-RF Probe to the predetermined electrode contact location using the specified spacer tube. A stylet may be used to ensure the lumen is patent prior to inserting the TA. The universal cable assembly remains attached to the sEEG-RF Probe while its cables are disconnected from the diagnostic head box. One (monopolar) or two (bipolar) cables from the universal cable assembly are inserted into the radiofrequency connector box (RFCB) depending on the contact area(s) to be ablated. The TA is also connected to the RFCB is attached to the Generator Interface Cable which is attached to the Generator. Temperature and time are used to create lesion (s).

The provided text describes the NeuroOne OneRF Ablation System, a radiofrequency lesion generator and probe indicated for creating radiofrequency lesions in nervous tissue for functional neurosurgical procedures.

Here's an analysis of the acceptance criteria and study proving the device meets them, based solely on the provided text:

Important Note: The provided text is a summary from an FDA 510(k) premarket notification. It describes the device, its intended use, comparison to predicate devices, and a high-level summary of performance testing. It does not contain detailed pass/fail acceptance criteria values for most tests or granular study design information (e.g., specific sample sizes for particular experiments, expert qualifications, or detailed ground truth methodologies beyond "lesion size was determined"). The information here is inferred from the "Results and Conclusions" section, which consistently states "Pass" or "Met applicable requirements."

1. Table of Acceptance Criteria and Reported Device Performance

Given the lack of specific quantitative acceptance criteria in the provided text, the table below will list the tests performed and their reported outcomes, implying that the device met the (unstated) acceptance criteria for each.

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