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The Trex HD is an electroencephalograph intended 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 Natus Medical Incorporated DBA Excel-Tech Ltd. (XLTEK) Trex_HD is a complete data acquisition system that incorporates built-in amplifiers, A/D converters, digital signal processors, and storage devices. The Trex_HD incorporates the following patient inputs: 24 referential inputs; DC inputs; Differential inputs; Pulse oximeter/photic input; and Patient event switch input. The Trex_HD also incorporates the following connection to a XLTEK DT computer running NeuroWorks or SleepWorks software applications: USB connection; External battery pack connection; and Bluetooth (BT) wireless connection. The Trex_HD is powered by two (2) AA batteries, or may utilize an external battery pack for longer studies.

This document describes a 510(k) premarket notification for the Trex HD electroencephalograph. The information provided outlines the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain information regarding diagnostic performance or a clinical study that proves the device meets specific performance acceptance criteria related to disease detection or diagnosis. Instead, the document focuses on technical verification against established standards.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The document describes performance in terms of compliance with various technical and safety standards, rather than diagnostic accuracy or clinical metrics. The acceptance criteria are essentially meeting these standards.

• Robust software development process
• Verification and validation according to internal requirements and FDA guidance documents (e.g., "The content of premarket submissions for software contained in medical devices," "Off-the-shelf software use in medical devices," "General principles of software validation") and standards (IEC 62304: 2006). | "Results indicate that the XLTEK Trex_HD firmware complies with its predetermined specifications, the applicable guidance documents, and the applicable standards." |
  | Electrical Safety:
• Compliance with IEC 60601-1: 2005, Am1: 2012 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance).
• Compliance with IEC 60601-1-11: 2011 (Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance -Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment). | "Results indicate that the XLTEK Trex_HD complies with the applicable standards." |
  | Electromagnetic Compatibility:
• Compliance with IEC 60601-1-2: 2007 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests). | "Results indicate that the XLTEK Trex_HD complies with the applicable standards." |
  | Performance Testing – Bench:
• Compliance with internal requirements and applicable clauses of:
  • IEC 60601-1-6: 2010 (Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance – Collateral standard: Usability)
  • IEC 60601-2-26: 2012 (Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs)
  • IEC 62366: 2007 (Medical devices – Application of usability engineering to medical devices)
  • ISO 80601-2-61: 2011 (Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment). | "Results indicate that the XLTEK Trex_HD complies with its predetermined specifications and the applicable standards."
    "The results of these activities demonstrate that the XLTEK Trex_HD is as safe, as effective, and performs as well as or better than the predicate devices. Therefore, the XLTEK Trex_HD is considered substantially equivalent to the predicate devices." |

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document details bench testing and verification/validation activities for hardware and software compliance with standards, not a clinical study involving patient data. Therefore, there's no mention of a "test set" in the context of patient data, sample size, or data provenance. The testing was likely conducted in a lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This was not a clinical study with a "ground truth" derived from expert interpretation of patient data. The "ground truth" here is compliance with technical and safety standards, which would be assessed by engineers and quality assurance professionals.

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

Not applicable. No clinical test set.

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 applicable. This is not an AI-assisted diagnostic device, nor is it a multi-reader multi-case study. It's an Electroencephalograph (EEG) system.

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

Not applicable. The device itself is an ECG system, not an algorithm. The software mentioned is part of the system's operation and data management, and its performance was verified against its specifications and relevant standards.

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

For the technical and safety performance, the "ground truth" is defined by the specific requirements and limits set forth in the international and FDA-recognized standards (e.g., IEC 60601-1, IEC 60601-2-26) and the device's predetermined specifications.

8. The sample size for the training set

Not applicable. This document does not describe a machine learning or AI algorithm with a training set.

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

Not applicable. No training set.

In summary, the provided document focuses on demonstrating technical and safety substantial equivalence of the Trex HD electroencephalograph to a predicate device, as required for a 510(k) submission. It details compliance with manufacturing, electrical safety, EMC, and performance standards through bench testing and verification/validation activities. It does not include information about clinical performance, diagnostic accuracy, or studies involving patient data interpreted by experts.

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