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Siemens INFINITY EEG Pod is indicated for use in the adult, pediatric and neonatal populations, in an Stement where patient care is provided by healthcare professionals, i.e. Physicians, Nurses, Technicians, when the professional determines that the device is required to monitor the state of the brain by data acquisition of EEG signals.

The INFINITY EEG pod is an addition to Siemens SC9000/SC8000/SC7000/SC9000XL INFINITY patient monitoring series. When connected to an INFINITY EEG pod, an INFINITY Modular Bedside Monitor is capable of measuring up to four channels of EEG waveforms. Each waveform has its own parameter box, and each parameter box displays up to three parameters that can be trended, printed, and displayed on a central station.

This looks like a 510(k) premarket notification for a medical device called the Siemens INFINITY EEG Pod. The goal is to show substantial equivalence to a previously cleared device, the Aspect Medical Systems, Inc. Model A-1000 EEG Monitor (K963644).

However, the provided text does not contain the detailed acceptance criteria or the study that proves the device meets them in the way you've requested (e.g., specific performance metrics, sample sizes, ground truth establishment, MRMC studies, etc.). Instead, it focuses on the device description, intended use, comparison tables for features with a predicate device, and general statements about assessment of non-clinical and clinical performance data for equivalence.

The document lists "Exhibit U" for "Assessment of non-clinical performance data for equivalence" and "Exhibit V" for "Assessment of clinical performance data for equivalence." These exhibits would likely contain the detailed information you're looking for, but they are not included in the provided text. The FDA letter confirms substantial equivalence based on the submitted materials, but the specific study details are omitted from this summary.

Given the information provided, I can only fill out very limited parts of your requested table and study description based on what's explicitly stated.

Summary of Available Information Regarding Acceptance Criteria and Study:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text. The submission hinges on demonstrating "substantial equivalence" to the predicate device, meaning its performance should be comparable.
• Reported Device Performance: Not explicitly stated in the provided text in terms of quantitative metrics. The document states that "Exhibit U" contains non-clinical performance data and "Exhibit V" contains clinical performance data for equivalence, but these exhibits are not provided. The comparison table (Section 5) only highlights computed parameters, indicating that the Siemens INFINITY EEG Pod computes similar parameters (Total Power, Delta, Theta, Alpha, Beta Power, Spectral Edge Frequency, Median Frequency, Burst Suppression ratio) to the predicate device, but lacks some (Power of user-defined Bands, Asymmetry, Bispectral Index, EMG Power Bands). This suggests an implicit acceptance criterion of performing adequately on the shared parameters.

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

• Sample Size: Not specified in the provided text. The "Exhibit V: Assessment of clinical performance data for equivalence" would likely contain this information.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). This would typically be found in the detailed clinical study report.

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

• Not specified in the provided text.

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

• Not specified in the provided text.

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 specified and highly unlikely for this type of device (EEG signal acquisition and parameter computation) from 1999. The device is for "data acquisition of EEG signals" and parameter calculation, not for image interpretation by human readers. It is not an AI-assisted diagnostic tool.

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

• This device functions as a standalone acquisition and computation unit in its core function (measuring EEG and deriving parameters). The performance assessment mentioned in "Exhibit U" (non-clinical) and "Exhibit V" (clinical) would have evaluated its ability to accurately acquire signals and compute parameters, which is essentially its "standalone" performance. However, no specific details of such a study are included here.

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

• Not specified in the provided text. For an EEG device primarily measuring and processing signals, ground truth would likely involve:
  • For signal acquisition: Comparison against a gold-standard EEG amplifier/recorder using known electrical signals or phantom tests, and in clinical settings, potentially expert review of raw waveforms for signal quality.
  • For computed parameters: Validation of algorithms against known mathematical derivations and possibly against another validated device or manual calculations from raw EEG data by experts.

8. The sample size for the training set:

• Not applicable/Not specified. This device is an acquisition and signal processing unit, not an AI/machine learning model that typically involves a distinct "training set." Its algorithms are based on established signal processing techniques, not learned from data in the same way a deep learning model would be.

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

• Not applicable/Not specified, as it's not an AI/ML device with a training set.

Conclusion:

The provided text from the 510(k) summary for the Siemens INFINITY EEG Pod (K991012) describes the device, its intended use, and its substantial equivalence to a predicate. It refers to exhibits containing non-clinical and clinical performance data (Exhibit U and Exhibit V, respectively), but the detailed acceptance criteria and the specifics of the studies proving these criteria are not included in this document. Therefore, I cannot provide most of the requested information based solely on the input text.

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