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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.

Details of the Study Proving Device Meets Acceptance Criteria:

Given the nature of the device (radiofrequency ablation system) and the provided 510(k) summary, the "study" primarily refers to a series of non-clinical performance tests rather than a typical clinical trial involving medical imaging data analysis.

1. Sample sizes used for the test set and the data provenance:

   • Test Set (Non-Clinical Performance Tests): The document does not specify exact sample sizes for each non-clinical test (e.g., number of probes tested for durability, number of lesions created for size testing). It generally refers to these as "testing" or "activities."
   • Data Provenance: Not explicitly stated, however, the tests are laboratory-based ("ex-vivo tissue" mentioned for lesion size testing) rather than human or geographical. All studies are described as "design verification and validation activities."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the document. For engineering performance tests (e.g., electrical safety, mechanical integrity, sterilization), "ground truth" is typically established by objective measurement against engineering specifications rather than expert consensus. For "Lesion Size Testing," the document states "Lesion sizes were determined based on time and temperature," implying measured outcomes rather than expert visual assessment establishing "ground truth."

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

   • Not applicable/Not mentioned. For engineering performance tests, outcomes are typically definitive (pass/fail against a specification) and do not usually involve adjudication in the way that clinical imaging studies might.

4. 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:

   • No. This type of study (MRMC for AI-assisted human readers) is not applicable to a radiofrequency ablation system as described. The device is a direct treatment tool, not an AI diagnostic aid that assists human readers in interpreting medical images.

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

   • The device functions as a system with a human operator (neurosurgeon) in control ("Operator controlled; RF delivered from RF generator to compatible sEEG - RF probes to create lesions in nervous tissue"). Performance tests were conducted on the system, including the generator, probes, and software, to ensure it operates according to specifications. While software verification was done, the "standalone" performance in the context of an AI-only diagnostic algorithm is not relevant here.

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

   • For Lesion Size Testing: "Lesion sizes were determined based on time and temperature." This suggests direct physical measurement or calculation based on set parameters and observed outcomes, likely in ex-vivo tissue as mentioned in the table.
   • For other engineering tests: The "ground truth" is adherence to established engineering specifications, international standards (e.g., IEC, ISO, ASTM), and design requirements. This is verified through direct measurement, functional testing, and environmental challenges.

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning algorithm that requires a training set in the conventional sense for diagnostic image analysis. Its software facilitates control and monitoring of the ablation process. Software verification was conducted in accordance with relevant FDA guidance and IEC 62304.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the context of an AI algorithm learning from data. The software within the device is deterministic and performs control functions based on predefined algorithms and parameters. Ground truth for software verification typically involves demonstrating that the software meets its specified functional and non-functional requirements through testing against those requirements.

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