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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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