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The Nurochek-II System is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years old, for the aid in diagnosis of mild traumatic brain injury (mTBI) in conjunction with a standard neurological assessment.

The Nurochek-II System is indicated for the generation of visual evoked potentials (VEPs) and to acquire, transmit, display, and store electroencephalograms (EEGs) during the generation of VEPs. Additionally, the system is indicated to analyze captured EEG signals to provide an aid in the diagnosis of mild traumatic brain injury (mTBI) in subjects aged between 16 and 46 years old who have sustained a potential head injury in the past 72 hours (3 days).

The Nurochek-II System is a portable system designed to generate visual evoked potentials (VEPs) in patients and acquire, transmit, display, and store the resulting electroencephalogram (EEG). It is intended for prescription use in healthcare facilities for subjects aged between 16 and 46 years, to aid in the diagnosis of mild traumatic brain injury (mTBI). The primary components of the Nurochek-II System are the wearable headset, the Nurochek-II software application, and the Nurochek-II server.

Here's a breakdown of the acceptance criteria and the study details for the Nurochek-II System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly state "acceptance criteria" for sensitivity and specificity in a separate section. However, it presents the performance of the Nurochek-II System and compares it to a predicate and reference device, implying these metrics are key for demonstrating substantial equivalence. Given the context, the performance metrics reported for the Nurochek-II System are the results of its performance against a clinical diagnosis.

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

• Sample Size for Test Set: 110 individual Steady-State Visual-Evoked Potential (SSVEP) readings.
• Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer, Headsafe MFG Pty Ltd., is based in Surry Hills, NSW, Australia, suggesting the study may have been conducted in Australia or related clinical sites.
• Retrospective or Prospective: The study is described as a "clinical investigation" with a "clinical research protocol" and the collection of readings within 72 hours of suspected head injury, followed by a clinical evaluation. This indicates a prospective study design.

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

• Number of Experts: Not explicitly stated as a specific number. The document mentions "Each highly trained physician." This phrasing suggests multiple physicians were involved, but the exact count is not provided.
• Qualifications of Experts: "Highly trained physician" using "their education and experience to deliver their mTBI determination." This included a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information provided by the study subject.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1). It states that "Each highly trained physician used their education and experience to deliver their mTBI determination." This implies that the individual physician's diagnosis served as the ground truth without a stated consensus or adjudication process among multiple ground truth experts for each case.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focuses on the standalone performance of the Nurochek-II System against a clinical diagnosis. There is no information provided about human readers improving with AI vs. without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was done. The reported sensitivity, specificity, PPV, and NPV are for the Nurochek-II System's classification algorithm in differentiating between subjects with and without mTBI, based solely on the analysis of captured EEG signals.

7. The Type of Ground Truth Used

The ground truth used was expert clinical diagnosis. This was established by "a licensed healthcare professional" (a "highly trained physician") based on a standard neurological assessment, a concussion-related signs and symptom evaluation, and a review of relevant patient information.

8. The Sample Size for the Training Set

The classification algorithm was "generated with 372 individual steady-state visual-evoked potential (SSVEP) readings." This indicates that the training set consisted of 372 individual SSVEP readings.

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

The ground truth for the training set was established through the same method as the test set: a clinical evaluation by a licensed physician. The protocol required readings to be collected within 72 hours of suspected head injury, in addition to a clinical evaluation by a licensed physician. Their determination was based on a neurological examination, a concussion-related signs and symptom evaluation, and a review of all relevant information.

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