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This product is intended for use by a trained EEG reader.
This software is intended for use by a trained EEG technician or neurologist.

The Persyst Prism is a software only product. It runs on a personal computer and requires no specialized hardware. It displays digitized EEG signals, power spectra, topographic maps, etc. These functions are all controlled and interpreted by the digitized EEG input is read from a file on the personal computer (or available across the network).

Neither the computer nor the software control the delivery of energy, the administration of parenteral drugs, or another form of life sustaining function to the patient.

The provided text is a 510(k) summary for the PERSYST PRISM device, submitted in 1997. Unfortunately, it does not contain the detailed information required to answer many of the questions. The document primarily focuses on demonstrating substantial equivalence to a predicate device (STELLATE RHYTHM) based on descriptive characteristics and intended use, rather than presenting a performance study with acceptance criteria and results.

Here's a breakdown of what can be extracted and what information is missing:

Description of the Device

The Persyst Prism is a software-only product that runs on a personal computer. It displays digitized EEG signals, power spectra, topographic maps, etc. It requires the EEG signal to be digitized by a separate EEG acquisition system. It is intended for use by a trained EEG reader.

Missing Information Based on Source Document:

The provided 510(k) summary does not include any information regarding:

• Acceptance criteria for device performance.
• A performance study or clinical trial demonstrating the device meets specific criteria.
• Sample sizes for test or training sets.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts used for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of AI assistance for human readers.
• Standalone algorithm performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• How ground truth for any set was established.

Based on the provided document, the only aspect that remotely touches upon "performance" is the comparison of technological characteristics to a predicate device. This is not a performance study in the manner typically expected for acceptance criteria.

Therefore, a table of "acceptance criteria" and "reported device performance" as requested cannot be constructed from this document. The document states:

"Both Prism and Rhythm support the following digital EEG plots: average power spectrum, compressed spectral arrays, topographic spectrum, topographic voltage plots, and correlation and lag. Neither product utilizes a normative database. Rhythm is capable of digitizing an analog signal while Prism requires that the signal be digitized by a separate EEG acquisition system. Both are software only products."

This describes features, not performance metrics against acceptance criteria.

Summary of available and missing information:

1. Table of acceptance criteria and reported device performance: Not provided in the document. The document describes functional characteristics but not performance metrics or acceptance criteria.
2. Sample size used for the test set and the data provenance: Not provided in the document. No performance study details are included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document. No ground truth establishment is described.
4. Adjudication method for the test set: Not provided in the document.
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 provided in the document. The device is a "software only product" for displaying EEG signals, not an AI-assisted diagnostic tool in the modern sense.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided in the document. The device is intended "for use by a trained EEG reader."
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the document.
8. The sample size for the training set: Not provided in the document.
9. How the ground truth for the training set was established: Not provided in the document.

Conclusion:

The provided 510(k) summary from 1997 is a demonstration of substantial equivalence based primarily on a comparison of intended use, technological characteristics, and predicate device classification. It does not include the detailed performance study information, acceptance criteria, or ground truth establishment methodologies that are typically found in more recent regulatory submissions for devices that involve AI or machine learning algorithms with specific performance claims. At the time of this submission, the regulatory requirements and the nature of the device (a display and analysis tool, not an automated diagnostic system) likely did not necessitate such extensive performance data in the summary.

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