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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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The Evo® sEEG System is intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

The NeuroOne Evo® sEEG System is comprised of the Evo® sEEG Electrodes (which includes Anchor Bolt Cap and Stylet) accompanying Cable Assemblies, and the Evo® Anchor Bolts. The Evo® sEEG System components are provided sterile and are single use only. The Evo® sEEG Electrodes and Anchor Bolts are temporarily placed (less than 30 days) at the subsurface level of the brain. The system is designed to be used in stereoelectroencephalography (sEEG) procedures.

The sEEG electrodes, by way of the accompanying cable assemblies, are connected to recording, monitoring, or stimulation/response instrumentation commercially available for use with other sEEG electrodes, including the predicate device.

The sEEG electrodes are a 0.8mm diameter polyimide electrode with platinum contacts and are available in varying numbers of contacts: 5 to 16 contacts, with an exploration length (recording depth) from 16 to 80mm. The contact height is 2.0mm and spacing is 1.5-3.2mm apart.

The Evo® Anchor Bolts are available in 20mm, 30mm, and 35mm lengths, can only be used and placed through a small 2.1mm burr hole drilled in the skull, and should be used only when sEEG depth electrodes are warranted.

The provided text describes a 510(k) premarket notification for the Evo® sEEG System, focusing on its substantial equivalence to a predicate device, particularly regarding an extended duration of use. The core of the information revolves around biocompatibility testing to support this extended use.

Here's a breakdown of the requested information:

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

The acceptance criteria are implicitly derived from the ISO standards for biocompatibility testing, where "Pass" indicates meeting the acceptance criteria according to the standard. The reported device performance aligns with these "Pass" conclusions.

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

The document mentions specific tests, some of which imply sample sizes (e.g., "ISO Guinea Pig Maximization Sensitization" and "Chronic (29 Days) GLP Brain Tissue Implantation Study (Sheep)"), but it does not explicitly state the numerical sample sizes for each test. The data provenance (country of origin, retrospective/prospective) is also not explicitly provided in the given text. These were "performance evaluations... conducted to address the proposed extended duration of use" and "biocompatibility testing ... as part of this 510(k)", implying they were conducted for this submission.

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)

This section is not applicable to the provided document. The study described is a series of biocompatibility tests, not a clinical study involving expert interpretation of medical images or patient outcomes to establish a "ground truth" for a diagnostic device. The "ground truth" here is the biological reaction or material property as determined by standardized laboratory methods (e.g., cytotoxicity, sensitization, implantation response).

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

This section is not applicable. Adjudication methods are typically used in clinical trials or studies where human readers independently assess data and then resolve disagreements. The biocompatibility tests are laboratory-based and follow established protocols.

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

This section is not applicable. The device is an sEEG electrode system, not an AI-powered diagnostic tool. The performance studies detailed are physical and biological evaluations of the device material and function, not its interpretative assistance capabilities for human readers.

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

This section is not applicable. As stated above, the device is an sEEG electrode system, not an algorithm, and therefore, an "algorithm only" performance evaluation is not relevant.

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

The "ground truth" in this context is the biological and material reaction observed and measured through standardized laboratory tests (e.g., presence/absence of cytotoxicity, level of irritation, tissue response from implantation). This is derived directly from the results of the specific ISO-standardized tests rather than a clinical ground truth like pathology or expert consensus.

8. The sample size for the training set

This section is not applicable. The provided document describes device performance testing for regulatory submission, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of this submission.

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

This section is not applicable for the same reasons as point 8.

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The Evo sEEG System is intended for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain.

The NeuroOne Evo sEEG System is comprised of the Evo sEEG Electrodes (which includes Anchor Bolt Cap and Stylet) accompanying Cable Assemblies, and the Evo Anchor Bolts. The Evo sEEG System components are provided sterile and are single use only. The Evo sEEG Electrodes are temporarily placed (less than 24 hours) at the subsurface level of the brain. The system is designed to be used in stereoelectroencephalography (sEG) procedures. The sEEG electrodes, by way of the accompanying cable assemblies, are connected to recording, monitoring, or stimulation/response instrumentation currently commercially available for use with other sEEG electrodes, including the predicate device. The sEEG electrodes are a 0.8 mm diameter polyimide electrode with platinum contacts and are available in varying numbers of contacts: 5 to 16 contacts, with an exploration length (recording depth) from 16 to 80 mm. The contact height is 2.0 mm and spacing is 1.5-3.2 mm apart. The Evo Anchor Bolts are available in 20 mm, 25 mm, 30 mm, and 35 mm lengths, can only be used and placed through a small 2.1 mm burr hole drilled in the skull, and should be used only when sEEG depth electrodes are warranted.

The NeuroOne Evo sEEG System, a depth electrode for temporary brain electrical signal recording, monitoring, and stimulation, has been deemed substantially equivalent to its predicate device, the DIXI Medical Microdeep Depth Electrode. This determination is based on a comprehensive set of performance tests.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific quantitative acceptance criteria for each test. Instead, for all "Non-Clinical Performance Tests," "Biocompatibility" tests, and a "Simulated Use and Implantation Accuracy Study," the reported performance is a concise "Pass – All samples passed the acceptance criteria" or similar statements like "Pass - Non-cytotoxic," "Pass - Did not elicit a sensitization response," etc. This indicates that predefined criteria were met for each test, but the exact numerical thresholds are not provided in this summary.

Summary of Performance Testing and Results:

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

• Non-Clinical Performance, Biocompatibility, Sterility, Shelf-Life, and Packaging Tests: The document consistently states "All samples passed the acceptance criteria" for these tests, implying multiple samples were tested for each. However, the exact sample sizes for each individual test are not specified.
• Simulated Use and Implantation Accuracy Study: The sample size is not explicitly stated, but it was a "human cadaver study." The data provenance is implied to be from a controlled laboratory setting (conducted by NeuroOne Medical Technologies Corp.) rather than clinical data from a specific country, and it is a prospective study (testing the device).

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

• Non-Clinical Performance, Biocompatibility, Sterility, Shelf-Life, and Packaging Tests: These types of tests typically rely on established scientific and engineering standards and validated methodologies rather than expert consensus for ground truth. The "ground truth" would be the fulfillment of the specified technical criteria within the standards. Therefore, an explicit number of experts and their qualifications for establishing ground truth as one might see in a clinical algorithm study is not applicable here.
• Simulated Use and Implantation Accuracy Study: The document does not specify the number or qualifications of experts used to establish the ground truth for implantation accuracy in the human cadaver study. The comparison was made against the predicate device, implying that accuracy was measured objectively according to predefined metrics.

4. Adjudication Method for the Test Set:

• For the non-clinical tests, the adjudication method is via comparison to predefined acceptance criteria within established standards (e.g., ISO, ASTM, IEC). This is typically an objective pass/fail assessment rather than a human adjudication process.
• For the "Simulated Use and Implantation Accuracy Study," the adjudication method is not explicitly stated. The conclusion that "no significant difference" was found implies a statistical comparison of measured implantation accuracy between the subject and predicate devices. No human adjudication process (like 2+1 or 3+1) is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The study focused on demonstrating substantial equivalence through technical and performance characteristics, and a simulated use study comparing the subject device to a predicate, not on human reader performance with or without AI assistance. The device itself is an implantable electrode, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

This concept is not relevant to the Evo sEEG System, as it is a physical medical device (electrode) and not an algorithm or software-only device. Performance studies were conducted on the device's physical and electrical characteristics.

7. Type of Ground Truth Used:

• Non-Clinical Performance, Biocompatibility, Sterility, Shelf-Life, and Packaging Tests: The ground truth for these tests is based on adherence to established international and national standards (e.g., ISO, ASTM, IEC) and internal specifications. This is objective and measurable data compared against predefined thresholds.
• Simulated Use and Implantation Accuracy Study: The ground truth for implantation accuracy would be derived from objective measurements taken within the cadaver study, comparing the planned trajectory/placement with the actual placement, likely using imaging modalities.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable as this is a physical medical device, not a machine learning algorithm that requires training data.

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

This question is not applicable, as there is no training set for this device.

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