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The intended use of the CerebraLogik is to monitor the state of the brain by acquisition of EEG signals and display the stored EEG in a compressed form of Amplitude Integrated EEG - aEEG and in conjunction with other clinical data.

The CerebraLogik consists of a dual channel EEG amplifier that is put near the monitored patient. The amplifier is connected, using an interface cable, to a Mennen Medical patient monitor via the UIM input of the monitor. The monitor has display options for both real time EEG and history of Amplitude Integrated EEG - aEEG. The monitor stores both EEG and aEEG signals for the duration of the EEG monitoring.

The provided documentation describes the CerebraLogik aEEG device, intended to monitor brain activity by acquiring EEG signals and displaying them as Amplitude Integrated EEG (aEEG). The submission is a Traditional 510(k) for the addition of this aEEG functionality to Mennen Medical's existing VitaLogik monitor family, asserting substantial equivalence to the Olympic CFM 6000 (K031149).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Olympic CFM 6000) through bench testing and an animal study, comparing device characteristics and output patterns. The reported "performance" is that the CerebraLogik produced "same aEEG graphs" and "same aEEG pattern" as the predicate device under specific testing conditions.

Here's a table summarizing the comparative characteristics and the reported findings for direct comparison points:

Note: The acceptance criteria are implicitly drawn from the predicate device's specifications and the expectation that the new device should perform equivalently or better without raising new safety/effectiveness concerns.

2. Sample Size Used for the Test Set and Data Provenance

• Bench Test (Simulated Use): EEG signal from one Grass EEG Simulator model EEG SIM. The signal was inserted in parallel to both devices for periods of 3 hours. Data provenance for the simulated signal is not explicitly stated but implies a synthetic source, not patient data.
• Animal Study: EEG signals from anesthetized piglets. The number of piglets is not specified but it states "piglets" (plural). The recordings were made in parallel on both devices for periods of 3 and 7 hours. Data provenance is an animal model, not human patients. This data is retrospective for the purpose of the study as it was collected for comparison.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of human experts to establish ground truth for either the bench test or the animal study. The "ground truth" seems to be the output of the predicate device itself, with the new device's output being compared against it.

4. Adjudication Method for the Test Set

Since human experts were not used to establish ground truth or compare outcomes, there was no adjudication method described. The comparison was based on direct observation of "same aEEG graphs" and "same aEEG pattern" by the study's researchers/engineers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described focuses on technical equivalence and functional comparison of the device's output to a predicate device and simulated/animal signals, not on human reader performance with or without AI assistance.

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

The studies described are essentially standalone performance evaluations of the device's signal acquisition and processing capabilities. The device's output (aEEG graphs/patterns) was compared directly to the predicate device and the input signals, without a human in the loop affecting the device's generation of the aEEG display. The product itself, CerebraLogik aEEG, is a standalone module integrated into a monitor, providing processed EEG data for clinicians to interpret, but its output generation is algorithm-only.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the bench test, the ground truth was effectively the known electrical signal from the Grass EEG Simulator and the output of the predicate device (Olympic CFM 6000) when fed this signal.
• For the animal study, the ground truth was the physiological EEG signal from anesthetized piglets, and the comparative output of the predicate device (Olympic CFM 6000) under the same conditions.

In both cases, it's a form of empirical comparison against a known input or a legally marketed predicate device's output, rather than an expert consensus, pathology, or outcomes data from human patients.

8. The Sample Size for the Training Set

The document does not mention any training set. The CerebraLogik aEEG module appears to be based on fixed algorithms for filtering, rectifying, and compressing EEG signals, rather than a machine learning model that would require a distinct training set. The descriptions focus on the implementation of these algorithms and their output comparison, not on their development or training.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned and the device's technology appears to be based on established signal processing rather than machine learning, this question is not applicable based on the provided text.

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