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preserving the full fidelity of the original EEG waveform data in the EEG patient population while providing tools for displaying and printing EEG waveforms for review and interpretation by trained health care professionals.

The Equinox™ Digital EEG System incorporates products produced by Physiometrix and Neuro Concepts to provide a superior system for EEG recording that provides cost benefits to the user. The Equinox™ System features several Physiometrix products including the Biosensor electrodes, e-Net headpiece. Patient Module, fiber optic cable and DSP Interface Card and computer hardware. The last component of the system is the Neuro Concepts software described in K905435B UNIQUANT'M System. The Equinox™ is an EEG system that offers a choice of paper or paperless approaches to reading of EEG records and automatic archival of EEG data onto optical disks. The highest priority of the system is to ensure the quality of the EEG data acquisition and storage thus preserving the full fidelity of the raw analog EEG waveform for reproduction onto paper or for display on a computer monitor. EEG data that is acquired on the Equinox™ System is always archived directly onto optical disk with no means available to the system operator to modify or process the raw digitized data.

The provided text describes the Physiometrix Equinox™ Digital EEG System, but it does not contain information related to specific acceptance criteria, a study proving device performance against those criteria, or the detailed aspects of a clinical study (like sample sizes, ground truth establishment, or expert involvement).

The document is a 510(k) Premarket Notification summary, which focuses on establishing substantial equivalence to predicate devices. It emphasizes maintaining the fidelity of EEG data acquisition, storage, and display compared to existing systems.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria: The document does not list quantitative or qualitative acceptance criteria that the device had to meet (e.g., accuracy percentages, sensitivity, specificity, or specific performance metrics for EEG signal quality).
• No Performance Study Details: While the document states the system ensures "quality of the EEG data acquisition and storage" and "preserves the full fidelity of the original EEG waveform data," it doesn't describe an actual study conducted to demonstrate this. There are no reported device performance numbers.
• Focus on Substantial Equivalence: The text primarily argues that the Equinox™ System has the "same intended use" and "basic functionality" as its predicate devices (K930080 HydroDot NeuroMonitoring System and K905435B UNIQUANT™ System). This is a regulatory argument for market clearance, not a summary of a clinical performance study with defined acceptance criteria.
• "Minor Concern" Classification: The document refers to the FDA Draft Reviewer Guidance for Computer Controlled Products and classifies the software as having "minor concern" because there is "no risk or danger to the patient" even with inadvertent misuse. This speaks to safety, not diagnostic or interpretive performance.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, experts, adjudication, MRMC studies, or standalone performance because this information is not present in the provided 510(k) summary.

The document is a regulatory submission aimed at demonstrating equivalent technology and safety, not a detailed report of a performance study against specific, measurable criteria.

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