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The 84 Channel EEG is intended to be used as an electroencephalograph: to acquire, display, store, and archive electroencephalographic signals.

The 84 Channel EEG is a digital electroencephalograph

The provided document is a 510(k) premarket notification for an XLTEK 84 Channel EEG device. It establishes substantial equivalence to a predicate device (24 Channel Ambulatory EEG [FDA 510(k) K982479]) rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in these documents.

The 510(k) summary (pages 0 and 3) explicitly states that the device is "substantially equivalent" to the predicate device. This means the FDA has determined that the new device is as safe and effective as a legally marketed predicate device, and it does not typically involve the rigorous performance testing and clinical studies that would require the detailed information you've requested (such as sample sizes, ground truth establishment, MRMC studies, or standalone algorithm performance).

Here's what can be extracted based on the provided text, and where information is missing:

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

• Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for the new device. The acceptance criterion for the 510(k) submission itself is "substantial equivalence" to the predicate device.
• Reported Device Performance: None are explicitly reported in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) within these documents. The performance is implicitly assumed to be equivalent to the predicate device.

Missing Information & Rationale:

The following requested points are not applicable or cannot be answered from the provided 510(k) summary documents, as they pertain to performance studies that are not typically required or detailed in a 510(k) for substantial equivalence based on functional equivalence to a predicate device.

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
  • Not applicable / Not provided: There is no mention of a test set or data provenance for a performance study.
• 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 / Not provided: No ground truth establishment activity is described for the new device's performance.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
  • Not applicable / Not provided: No test set adjudication is 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
  • Not applicable: This device is an EEG acquisition and display system, not an AI-assisted diagnostic tool. No MRMC study or AI component is mentioned.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
  • Not applicable: This is a hardware/software system for acquiring EEG signals, not an algorithm being evaluated in a standalone mode.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
  • Not applicable / Not provided: No ground truth is established for device performance in this document.
• 8. The sample size for the training set
  • Not applicable / Not provided: No training set is mentioned as this is not an AI/ML device that learns from data.
• 9. How the ground truth for the training set was established
  • Not applicable / Not provided: No training set or ground truth establishment for it is mentioned.

In summary: The provided documents are a 510(k) summary and FDA clearance letter for an EEG device, focused on establishing substantial equivalence to an existing predicate device manufactured by the same company. This process generally does not involve new clinical performance studies with acceptance criteria, test sets, or ground truth establishment in the way you've described for, for example, a new diagnostic algorithm. The "study" here is the regulatory assessment of its technical characteristics and indications for use against a known predicate.

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