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The SignalNED Device is intended to record and display Quantitative EEG (qEEG) (relative band power, e.g., alpha, beta, delta, theta), which is intended to help the user analyze the EEG. The SignalNED does not provide any diagnostic conclusion about the patient's condition. The device is intended to be used on adults by qualified medical and clinical professionals.

The SignalNED is intended to be used in a professional healthcare environment.

The SignalNED Model RE machine uses 10 patient electrodes (4 left, 4 right, 2 midh are used to form the 8 channels. The SignalNED machine requires the use of the SignalNED Sensor Cap, and the system includes the following components:

• Portable EEG machine (Device)
• I Battery & External Battery Charger
• I SignalNED Sensor Cap
• I SignalNED Sensor Cap Cable

The primary function of the SignalNED Model RE is to rapidly record EEG and derive the Quantitative EEG (qEEG) measurement of Relative Band Power for multiple bands (e.g., alpha, beta, theta) at each electrode. These measurements are intended to help the user analyze the underlying EEG. The SignalNED Model RE (client) achieves its intended without relying on wireless comectivity. The SignalNED RE does not provide any diagnostic conclusion about the patient's condition.

This summary describes the acceptance criteria and the study that proves the SignalNED System (Model RE) meets those criteria, based on the provided FDA 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample sizes (e.g., number of subjects, number of EEG recordings) used for the non-clinical performance testing. It only states that "All testing passed acceptance criteria and details are contained in the test report." The data provenance (e.g., country of origin, retrospective or prospective) is also not detailed in this summary.

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

The provided document describes non-clinical performance testing (lead-off detection, noise levels, ADC accuracy, QEEG calculation accuracy, electrical performance, biocompatibility). These tests do not typically involve human experts establishing ground truth in the way a clinical study for diagnostic accuracy would. The ground truth for these tests would be established through defined technical specifications, measurement standards, and validated testing protocols. Therefore, information about the number and qualifications of experts for establishing ground truth is not applicable in this context.

4. Adjudication Method for the Test Set

As the performance testing described is non-clinical and based on technical specifications and standards, an adjudication method (like 2+1 or 3+1) used in clinical studies for discrepancies in expert readings is not applicable here. The acceptance criteria for each test inherently define the "ground truth" to which the device's performance is compared.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described in the provided document. The SignalNED System is intended to record and display QEEG, which "is intended to help the user analyze the EEG." It explicitly states, "The SignalNED does not provide any diagnostic conclusion about the patient's condition." This indicates that the device is a tool for professional analysis rather than an AI-driven diagnostic aid for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not described.

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

The document describes several standalone performance tests for the device's components and calculations (e.g., Lead Off Detection, Signal Acquisition Noise Levels, Software ADC Conversion Accuracy, Quantitative Electroencephalogram (QEEG) accuracy). These tests are conducted on the algorithm and hardware without human interpretation as part of the primary outcome assessment. For instance, the "Software ADC Conversion Accuracy" and "Quantitative Electroencephalogram (QEEG)" accuracy tests evaluate the algorithm's performance in generating calculated EEG measures.

7. The Type of Ground Truth Used

The ground truth used for the reported performance tests is based on:

• Defined Technical Specifications and Engineering Standards: For tests like Lead Off Detection, Signal Acquisition Noise Levels, Software ADC Conversion Accuracy, EC12:2020 Electrical Performance, and Essential Performance Tests (IEC 80601-2-26).
• Validated Calculation Methods: For the Quantitative Electroencephalogram (QEEG) Relative Band Power calculation, the ground truth would be based on established mathematical and signal processing principles for deriving these metrics from raw EEG data.
• International Biocompatibility Standards: For ISO 10993 series tests (Cytotoxicity, Sensitization, Irritation).

8. The Sample Size for the Training Set

The provided document describes performance testing for substantial equivalence, not the development or validation of a machine learning model with distinct training and test sets in the typical sense. While the device calculates QEEG, the details on how the underlying algorithms were developed or "trained" (if machine learning is involved beyond standard signal processing) are not provided. Therefore, a specific sample size for a "training set" is not mentioned.

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

As information about a distinct "training set" for machine learning algorithms is not provided, the method for establishing ground truth for such a set is also not described. The document focuses on performance testing against established engineering, electrical, and biocompatibility standards.

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The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 6 years and older. The Instant EEG Headband is intended for prescription use in the home, healthcare facility, or clinical research environment.

The Ceribell Instant EEG Headband is a 10 electrode EEG headband is non-sterile and disposable for single patient use and designed to be used exclusively with the Ceribell Pocket EEG Device (K170363) for EEG acquisition and recording.

The Ceribell Instant EEG Headband is comprised of the following components:

• An elastic fabric headband
• A cable attached to the headband to allow connection to an EEG acquisition/recording device
• 10 electrode assemblies, each consisting of the following:
  • Passive Silver/silver-chloride electrode
  • Reservoir filled with conductive electrolyte gel
  • Mechanism for dispensing gel onto patient scalp
  • Scalp-contacting prongs to prepare scalp for electrode contact

The Ceribell Instant EEG Headband is a Class II medical device (product code GXY) intended for single-patient use in recording EEGs for patients aged 6 years and older. It is disposable, non-sterile, and designed to be used exclusively with the Ceribell Pocket EEG Device (K170363). The headband comprises an elastic fabric headband, a cable for connection to an EEG acquisition/recording device, and 10 electrode assemblies. Each electrode assembly contains a passive silver/silver-chloride electrode, a reservoir filled with conductive electrolyte gel, a mechanism for dispensing gel, and scalp-contacting prongs for scalp preparation.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not explicitly state the specific sample sizes for each test in the performance data section. It consistently uses the phrase "All samples passed" for each test. The provenance of the data is that it was generated from performance testing conducted on the subject device (Ceribell Instant EEG Headband). The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though performance testing studies are typically prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the performance data presented primarily consists of engineering and biocompatibility testing against recognized standards (e.g., ANSI/AAMI EC12, ISO 10993) and functional verification tests. These tests do not involve expert interpretation or establishing ground truth in the way clinical studies with human assessors would.

4. Adjudication method for the test set

This section is not applicable for the same reasons above. The performance tests involve objective measurements against predefined criteria in established standards rather than subjective assessments requiring adjudication.

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

The document does not indicate that an MRMC comparative effectiveness study was done. The device described is an EEG electrode array (cutaneous electrode), not an AI-powered diagnostic algorithm or analysis tool. Its purpose is for the recording of EEG signals, not their interpretation or analysis using AI.

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

This section is not applicable. The Ceribell Instant EEG Headband is a hardware device (electrode array) for signal acquisition, not a standalone algorithm.

7. The type of ground truth used

For the performance tests:

• The "ground truth" or reference for the electrical performance tests (e.g., Impedance, DC Offset Voltage, Bias Current Tolerance, Defibrillation Overload Recovery, Combined Offset Instability and Internal Noise) was the specific requirements and methodologies outlined in the ANSI/AAMI EC12 standard.
• For the biocompatibility tests, the ground truth was the specific requirements and methodologies outlined in ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Irritation and Sensitization).
• For functional tests (e.g., Conductive Gel Delivery/Skin Prep Testing, Headband Size Range Testing, Simulated Use Testing, Packaging Performance Testing), the ground truth was the pre-defined functional specifications and expected performance criteria established for the device.

8. The sample size for the training set

This section is not applicable. The Ceribell Instant EEG Headband is a hardware device (electrode array) and does not involve AI or machine learning algorithms that require a "training set" in the conventional sense.

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

This section is not applicable as there is no training set mentioned for this hardware device.

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