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The Trex HD is an Electroencephalograph intended to be used to acquire, display, store and archive electroencephalographic signals, intended for electroencephalographic (EEG) or level 1-2 polysomnographic (PSG) recordings. The Trex HD amplifier is designed to be used with Natus NeuroWorks™or Natus SleepWorks™ software.

The Trex HD headbox is similar to the cleared Trex headbox (K042150). It contains a complete data acquisition system that has built-in amplifiers, A/D Converters, Digital Signal Processors, and storage devices. Trex HD, as the predicate device, is composed of 24 Referential Inputs, 2 DC Inputs, 3 Differential Inputs, Oximeter / Photic Connection, Patient Event Switch Connection, USB Connection, and Video Interface box. The wireless adapter is a part of Trex HD system. It connects to Camera (Camcorder) via LANC port. It is used to synchronize video frames with the EEG study recorded in Trex HD. It communicates wirelessly with the headbox and can store video synchronization internally in non-volatile memory in case the wireless communication is not possible. The Trex HD headbox is designed to work with an XLTEK computer system running NeuroWorks (K090019) or SleepWorks software (K090277). A camcorder can be used to record video. A (Trex HD) Video Interface Box is needed in order to synchronize video recording (on the camcorder) and EEG recording (on the Trex HD headbox).

This 510(k) summary describes a device, the Trex HD, which is substantially equivalent to a predicate device, the Trex (K042150). The primary change in the Trex HD is the addition of a Video Interface box for wireless video synchronization. The provided document does not contain a traditional performance study comparing the device against specific acceptance criteria with quantifiable metrics. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to established medical device standards.

Here's an analysis based on the provided text, addressing your questions as much as possible:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list acceptance criteria as quantifiable targets for a clinical performance study. Instead, the "acceptance criteria" are implied by the safety and performance specifications being "Same" as the predicate device (Trex K042150). The performance of the Trex HD is "reported" as Pass for specific verification tests.

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

The document states: "Non-clinical: Testing of the Natus Trex_HD was performed in compliance with Natus Corporation design control process." It then lists three verification tests that "Pass."

• Sample Size: The document does not specify a quantitative sample size for any of the verification tests. It implies that these tests were conducted on a sufficient number of devices or components to demonstrate compliance with design control processes.
• Data Provenance: The tests are non-clinical, implying they were conducted in a laboratory or engineering setting by the manufacturer, Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) in Oakville, Ontario, Canada. This is retrospective in the sense that the testing was performed during the development and verification phase of the device before submission for regulatory clearance. It is not clear if any data from humans was used for "Signal Quality Verification".

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

• Number of Experts: This information is not provided.
• Qualifications of Experts: This information is not provided.

Given that this is a non-clinical submission for an EEG amplifier and video synchronization system, and not an AI/diagnostic device that interprets medical images/signals, the concept of "ground truth established by experts" as in a clinical setting is not applicable here. The "ground truth" for these engineering verification tests would likely be established by comparing device output against known input signals or reference measurements using calibrated equipment.

4. Adjudication Method for the Test Set

This information is not provided, and it's generally not applicable for non-clinical engineering verification tests of this type. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies involving human interpretation or subjective assessment where consensus building is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• Was an MRMC study done? No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical: Clinical testing was not required to ensure safety and effectiveness of the modified device."
• Effect Size: Not applicable, as no MRMC study was performed.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

The device is an Electroencephalograph (EEG) and a video interface, not an AI algorithm. "Standalone performance" in this context would refer to the technical performance of the device hardware and its synchronization capabilities. The document reports "Pass" for "Trex HD Signal Quality Verification Test," "Trex Functionality Verification Test," and "Video Synchronization Verification Test." These are essentially standalone performance tests of the device's technical specifications.

7. The Type of Ground Truth Used

For the non-clinical tests ("Signal Quality Verification," "Functionality Verification," "Video Synchronization Verification"), the "ground truth" would be established by:

• Known input signals: Introducing precisely calibrated electrical signals to the EEG inputs and verifying the accuracy and fidelity of the recorded output signals.
• Reference timing standards: For video synchronization, comparing the timestamps generated by the device against a known, accurate time reference or by directly measuring synchronization accuracy between video frames and EEG datastreams.
• Conformance to engineering specifications: The device's electrical characteristics (e.g., resolution, noise, CMRR) are compared against the established design specifications, which are themselves based on industry standards and the performance of the predicate device.

It is not "expert consensus, pathology, or outcomes data," as these are clinical ground truths.

8. The Sample Size for the Training Set

This information is not applicable. The Trex HD is a medical device hardware system for acquiring physiological signals, not an AI or machine learning algorithm that requires a "training set."

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

This information is not applicable, as there is no training set for this type of device.

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