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The BraiNet® Kit contents are placed on the scalp to support electroencephalograph (EEG) electrode placement.

The BraiNet® Kit components are used by medical professionals and paraprofessionals to simplify placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of brain electrophysiology recording. The BraiNet® Kit is provided to the user non-sterile, with the exception of the subdermal EEG needle electrodes which are provided sterile and prepackaged. The BraiNet® Kit & individual components is a single patient use, disposable device.

This 510(k) summary does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the comprehensive study design. This is a very common scenario for 510(k) submissions, especially for predicate-based devices, which often rely on substantial equivalence rather than extensive de novo clinical trials.

The document primarily focuses on establishing substantial equivalence to a predicate device for a new EEG electrode cap and cutaneous electrodes. There isn't information about specific performance acceptance criteria for the device beyond its functional equivalence to the predicate, nor a detailed study proving it meets such criteria in a quantitative sense described by your request.

Here's an analysis of what information can be extracted or inferred based on the provided text, and what is explicitly missing:

1. Table of acceptance criteria and the reported device performance:

Missing Information: Specific quantitative performance metrics (e.g., impedance, signal-to-noise ratio, electrode stability over time, ease of application, patient comfort scores) that would typically be associated with detailed acceptance criteria for a medical device. The submission relies on the qualitative judgment of "substantial equivalence" to established predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not provided. The document does not describe a specific "test set" or a study involving human subjects or data where performance metrics were quantitatively measured beyond the claim of substantial equivalence.
• Data Provenance: Not applicable/Not provided. Since no specific test set data is described, its provenance (country of origin, retrospective/prospective) is not mentioned. The substantial equivalence argument is based on the design and intended use being similar to existing, legally marketed devices.

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

• Number of Experts: Not applicable/Not provided. No "ground truth" establishment by experts for a test set is described. The acceptance is based on an administrative review of the device's characteristics against its predicates.
• Qualifications of Experts: Not applicable/Not provided.

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

• Adjudication Method: Not applicable/None described. There is no test set or adjudication process mentioned.

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:

• MRMC Study: No. This device is an EEG electrode placement kit, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reading improvement with AI assistance is not relevant and was not performed/described.

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

• Standalone Performance Study: No. This device is a passive medical device (electrode cap and electrodes); it does not involve algorithms or AI, standalone or otherwise.

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

• Type of Ground Truth: Not applicable/Not explicitly defined. For this type of 510(k) submission, "ground truth" in the sense of a clinical outcome or diagnostic truth is generally not established for the new device. Instead, the "truth" is that the predicate devices are safe and effective for their intended use, and the new device is substantially equivalent to them in design and function. The 510(k) process aims to show that the new device does not raise new questions of safety or effectiveness compared to the predicate.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable/Not provided. This device is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.

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

• Ground Truth Establishment for Training Set: Not applicable/Not provided. As with point 8, this concept does not apply to the device described.

Summary of Device Performance (from the document):

The primary "performance" reported in this 510(k) is the assertion that:

• "The intended use and technology of the BraiNet® Kit and contents is substantially equivalent to the predicate devices."
• "No new questions of safety or effectiveness are raised."

The predicate devices are the Electro-Cap, Infa-Cap (for the BraiNet), and the AMBU Disposable Cup Electrode (for the BrainDisc). The performance of the new device is therefore deemed acceptable because it is considered to perform equivalently to these already cleared devices for their respective intended uses (EEG electrode placement and EEG recording).

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The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.

The BraiNet is used by licensed medical professionals to support placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of stimulation and recording. The BraiNet is provided to the user non-sterile. The BraiNet is a single patient use, disposable devices. The BraiNet is made from elastic and Velcro commercial garment grade materials.

The provided text is a 510(k) premarket notification for the Nicolet BraiNet device. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the following points from your request cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: This information is not present. The document concludes that the "intended use and technology...is substantially equivalent to the predicate device" and that "No new questions of safety or effectiveness are raised," but it does not provide specific performance metrics or acceptance criteria.
• Sample size used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 mentioned. This type of study is typically for evaluating AI-assisted diagnostic tools, which the BraiNet (an electrode cap) is not.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. Similarly, this is not relevant for the type of device.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
• The sample size for the training set: Not mentioned.
• How the ground truth for the training set was established: Not mentioned.

The document primarily focuses on:

• Description of the Device: BraiNet, an electrode cap for EEG electrode placement.
• Intended Use: Supports EEG electrode placement.
• Technological Characteristics: Made from elastic and Velcro commercial garment grade materials.
• Predicate Device: Electro-Cap (K780045).
• Conclusion: Substantial equivalence to the predicate device.

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