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The NeuroOne Cortical Electrodes are intended for temporary (less than 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.

The NeuroOne Cortical Electrode is a sterile, single use electrical conductor that is temporarily placed (

The provided text is a 510(k) summary for the NeuroOne Cortical Electrode. This document outlines the device's characteristics and compares it to a predicate device to establish substantial equivalence, which is a regulatory pathway for medical device clearance. It does not contain information about a study proving the device meets acceptance criteria in the context of a standalone or comparative effectiveness clinical study with performance metrics like sensitivity, specificity, or F1-score.

Instead, the "acceptance criteria" discussed here refer to the regulatory requirements for demonstrating equivalence to a legally marketed predicate device. The "study" proving acceptance criteria is a series of engineering and biocompatibility tests intended to show that the differences between the new device and the predicate do not raise new questions of safety or efficacy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the format typically used for studies evaluating diagnostic or predictive AI systems, nor can I answer questions related to sample size for test sets, ground truth establishment by experts, adjudication methods, or MRMC studies. These elements are not applicable to the type of regulatory submission described.

Here's a breakdown of what can be extracted from the document regarding the criteria and the "study" (testing) that supports the device:

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

The acceptance criteria are implicitly defined by the benchmarks set by the predicate device and relevant international standards. The "reported device performance" refers to the successful completion of various tests deemed sufficient to demonstrate equivalence.

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

This information is not provided because the "testing" is primarily engineering and bench testing, not a clinical study on patient data. There isn't a "test set" of patient data in the typical sense.

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):

Not applicable. Ground truth as defined for clinical studies (e.g., expert consensus for diagnostic accuracy) is not part of this 510(k) submission, which focuses on device safety and performance equivalence through engineering and biocompatibility testing.

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

Not applicable. There is no clinical test set requiring adjudication in this context.

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 device, and no MRMC study was conducted or referenced. The device is a cortical electrode, a physical medical instrument.

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

Not applicable. This is not an algorithm or AI device. The testing described focuses on the physical and electrical characteristics of the electrode.

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

The "ground truth" for this device's evaluation is primarily based on:

• Engineering specifications and standards: Conformance to pre-defined physical dimensions, electrical properties (IEC 60601), and material properties.
• Biocompatibility standards: Conformance to ISO 10993-1 and ASTM F756.
• Predicate device characteristics: The NeuroOne Cortical Electrode is deemed substantially equivalent if its performance aligns with that of the legally marketed predicate device (PMT Subdural Cortical Electrode) in terms of intended use, indications for use, technological characteristics, and safety profile, such that any differences do not raise new questions of safety or efficacy.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of an AI/machine learning model for this physical medical device.

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

Not applicable. As there is no training set, there is no establishment of ground truth for one.

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