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1. encevis is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid neurologists in the assessment of EEG. This device is intended to be used by qualified medical practitioners who will exercise professional judgment in using the information.

2. The seizure detection component of encevis is intended to mark previously acquired sections of adult (greater than or equal to 18 years) EEG recordings that may correspond to electrographic seizures, in order to assist qualified clinical practitioners in the assessment of EEG traces. EEG recordings should be obtained with a full scalp montage according to the standard 10/20-system.

3. The spike detection component of encevis is intended to mark previously acquired sections of the patient's EEG recordings that may correspond to spikes, in order to assist qualified clinical practitioners in the assessment of EEG traces. The Spike detection component is intended to be used in adult patients greater than or equal to 18 years. encevis Spike detection performance has not been assessed for intracranial recordings.

4. encevis includes the calculation and display of a set of quantitative measures intended to monitor and analyze the EEG waveform. These include frequency bands, rhythmic and periodic patterns, burst suppression and spectrogram. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

5. The aEEG functionality included in encevis is intended to monitor the state of the brain.

6. encevis provides notifications on an on-screen display for seizure detection, electrographic status epilepticus detection, spike detection, quantitative EEG and aEEG that can be used when processing a record during acquisition (online) or based on stored EEG files (offline). Notifications can also be provided to external systems via the external interfaces to make them accessible to the user through the external system in a human-readable format. Delays of up to several minutes can occur between the beginning of a seizure, electrographic status epilepticus, the occurrence of a spike or detection of quantitative EEG features and when the encevis notifications will be shown to a user. encevis notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.

7. encevis PureEEG (Artifact Reduction) is intended to reduce EMG and electrode artifacts in a standard 10-20 EEG recording. PureEEG does not remove the entire artifact signal and is not effective for other types of artifacts. PureEEG may modify portions of waveforms representing cerebral activity. Waveforms must still be read by a qualified medical practitioner trained in recognizing artifact, and any interpretation or diagnosis must be made with reference to the original waveforms.

8. This device does not provide any diagnostic conclusion about the patient's condition to the user.

9. The encevis Component for Detection of Seizures and Electrographic Status Epilepticus is indicated for the detection of Seizures and Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizures. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis analyzes EEG waveforms and identifies patterns that may be consistent with seizures and electrographic status epilepticus as defined in the American Clinical Neurophysiology Society's Guideline 14. EEG recordings should be obtained with a full scalp montage according to the standard 10/20-system. The diagnostic output does also include a measure of seizure prevalence ("seizure burden") within a 10 minute (short-term seizure burden) and a 60 minute (hourly seizure burden) moving window. The output of the Component for Detection of Seizures and Electrographic Status Epilepticus of encevis is intended to be used as a diagnostic output for determining patient treatment in acute-care environments. Detections from the Component for Detection of Seizures and Electrographic Status Epilepticus of encevis provide one input to the clinician that is intended to be used in conjunction with other elements of clinical practice to determine the appropriate treatment course for the patient. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis is intended for detection of electrographic status epilepticus only. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns. The Component for Detection of Seizures and Electrographic Status Epilepticus of encevis is not intended for use in Epilepsy Monitoring Units.

encevis combines several modalities for viewing and analyzing EEG data in one integrated software package. The software package can be used both as a standalone desktop application for opening and analyzing stored EEG files (offline mode) and as a module for integration into external EEG systems via the provided API interfaces, enabling the processing of real-time streaming data in online mode. encevis consists of the following modalities: encevis EEG-viewer, Artefact reduction encevis PureEEG, Seizure detection of encevis NeuroTrend, Detection of seizures and status epilepticus of encevis acute care, Spike detection encevis EpiSpike, Pattern detection and aEEG, Spectrogram, External Interface "encevis AITInterface", External Interface "encevis SeizureICUInterface".

Here's a breakdown of the acceptance criteria and study details for the encevis (2.1) device, based on the provided text:

Acceptance Criteria and Device Performance

The document outlines acceptance criteria and performance for several components of the encevis (2.1) device.

Table 1: Acceptance Criteria and Reported Device Performance

Study Details

2. Sample Size and Data Provenance

• Seizure Detection:
  • Test Set: 55 subjects (1603 hours of EEG data, max 30 hours per subject)
  • Data Provenance: Retrospective, patients from an epilepsy monitoring unit. Countries of origin are not specified, but the context implies it is likely from a clinical setting.
• Seizure Detection and Status Epilepticus (Acute Care):
  • Test Set: 81 patients (62.4 hours of EEG data)
  • Data Provenance: Retrospective, neurological/general intermediate care units or neurological/general intensive care units at two different sites in the US (31 patients) and outside of US (50 patients).
• Spike Detection:
  • Test Set: 23 patients
  • Data Provenance: Retrospective, patients from an epilepsy monitoring unit. Countries of origin are not specified, but the context implies it is likely from a clinical setting.
• Artifact Reduction:
  • Test Set: 128 EEG data records (10 seconds each) from different patient groups (60 epilepsy monitoring, 65 ICU patients).
  • Data Provenance: Retrospective, epilepsy monitoring units and ICU settings.
• Rhythmic and Periodic Patterns:
  • Test Set: 83 long-term EEGs from ICU patients, first minute of each hour, split into three 20-second segments (11935 common annotation segments).
  • Data Provenance: Prospective, two different centers. Countries are not specified.
• aEEG:
  • Test Set: "Real EEG data" for comparison with Persyst. (Specific sample size not provided for this comparison). Also sinusoidal test data.
  • Data Provenance: Not explicitly stated, but "real EEG data" implies clinical origin.
• Frequency Bands:
  • Test Set: Sinusoidal test data and manually selected EEG recordings from epilepsy/ICU patients. (Specific sample size not provided).
  • Data Provenance: Not explicitly stated, but "manually selected EEG recordings from epilepsy- or ICU patients" implies clinical origin.
• Burst Suppression:
  • Test Set: 83 long-term EEGs from intensive care patients (3978 valid annotation segments from the first minute of each hour).
  • Data Provenance: Retrospective?, two different centers. Countries are not specified.
• Spectrogram:
  • Test Set: Artificially created data and real EEG data. (Specific sample size not provided).
  • Data Provenance: Not explicitly stated, but "real EEG data" implies clinical origin.

3. Number of Experts and Qualifications for Ground Truth

• Seizure Detection: 3 independent neurologists, blinded review. Qualifications not explicitly stated beyond "independent neurologists".
• Seizure Detection and Status Epilepticus (Acute Care): 6 experienced, board-certified, and independent Neurologists, blinded review. Qualifications specified as "experienced, board-certified".
• Spike Detection: 3 independent neurologists, blinded review. Qualifications not explicitly stated beyond "independent neurologists".
• Artifact Reduction: 3 independent epileptologists or neurologists, blinded review.
• Rhythmic and Periodic Patterns: 2 clinical neurophysiologists, naive to the EEGs.
• Burst Suppression: 2 clinical EEG experts.

4. Adjudication Method for Test Set

• Seizure Detection: An event was considered a "true seizure" if the time interval of two out of three reviewers overlapped by at least 1 second.
• Seizure Detection and Status Epilepticus (Acute Care): Reference standard for seizures derived from 6 independent neurologists. Reference standard for ESE and seizure burden derived from consensus seizure annotations. The specific voting rule for "consensus" is not explicitly stated, but implies agreement among experts.
• Spike Detection: An event was considered a "true spike" if the time interval of two out of three reviewers overlapped.
• Artifact Reduction: Not explicitly stated for artifact detection itself, but for identifying clean EEG patterns and artifacts, 3 independent epileptologists or neurologists were involved. Implies consensus or agreement.
• Rhythmic and Periodic Patterns: Annotations had to be consistent between both reviewers to be used in sensitivity and specificity measurement. Cohens' kappa statistic (0.66) indicates substantial agreement.
• Burst Suppression: The detection performance was analyzed for consensus annotations of the two reviewers. Consensus annotations only included segments where both reviewers showed the same decision.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no explicit mention of an MRMC comparative effectiveness study where human readers improve with AI vs without AI assistance. The studies primarily focus on the standalone performance of the AI algorithms and compare them to predicate devices (other algorithms). In the case of "Rhythmic and Periodic Patterns", human reader agreement (inter-reader agreement) is used to establish ground truth, not to evaluate human performance with/without AI assistance.

6. Standalone Performance Study

Yes, standalone (algorithm only without human-in-the-loop performance) studies were done for all major components. The reported metrics like PPA, NPA, NDR, sensitivity, and specificity are all measures of the algorithm's performance against the established ground truth.

7. Type of Ground Truth Used

• Expert Consensus: This is the predominant type of ground truth used across all evaluated components. Experts (neurologists, epileptologists, clinical neurophysiologists) retrospectively reviewed EEG recordings and marked events like seizures, spikes, ESE, and patterns.
• Artificial Data: Used for validating aEEG, frequency bands, and spectrogram for initial functional verification.
• Pre-calculated Values: Used for validating the quantitative measure of amplitude loss in burst suppression.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set for any of the encevis (2.1) components. The studies described are validation studies using a test set.

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

Since the document does not provide information on the training set, it does not describe how the ground truth for the training set was established.

Ask a specific question about this device

The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs. 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 (K191301) 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

This FDA 510(k) summary for the Ceribell Instant EEG Headband (K232052) explicitly states "Performance Data: None required." and that the device is identical to its predicate (K210805) with only a modified Indications for Use Statement and associated labeling.

Therefore, the provided document does not contain the information necessary to answer the questions regarding acceptance criteria and a study that proves the device meets those criteria. It indicates that no performance data was needed for this specific submission because the device is essentially a re-labeled version of a previously cleared device.

Ask a specific question about this device

The Ceribell Instant EEG Headband is an electroencephalogram (EEG) electrode array intended for single patient use in the recording of EEGs in patients of 2 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 (K191301) 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 provided document is a 510(k) premarket notification decision letter from the FDA to Ceribell, Inc. regarding their Instant EEG Headband. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study report of the device's diagnostic performance against established acceptance criteria.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The "Performance Data" section within the 510(k) Summary lists the types of testing performed:

• Biocompatibility testing per ISO 10993-1, ISO 10993-5, and ISO 10993-10
• Bench testing and simulated use testing to verify system performance including testing and evaluation to ANSI EC12-2000 and IEC 60601-1 requirements.
• Shelf life testing

These tests are related to the safety and functionality of the electrode array itself (biocompatibility, electrical safety, durability, and signal acquisition quality) and not to the diagnostic performance of an AI algorithm or human-in-the-loop performance related to interpreting EEG signals. The device described is a cutaneous electrode array, not an AI-powered diagnostic tool.

Therefore, the requested information regarding acceptance criteria for AI algorithm performance, sample size for test sets, expert adjudication, MRMC studies, or standalone algorithm performance is not present in this document because the device being cleared is an EEG headband (hardware), not a software algorithm for interpreting EEG.

To answer your request, if this were an AI/software as a medical device (SaMD) submission, the following sections would typically be present, but they are absent here due to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance: This would typically define metrics (e.g., sensitivity, specificity, AUC) and their target values, along with the actual results from the study. (Not applicable/Not present)

2. Sample size used for the test set and data provenance:
* Sample Size: Not applicable.
* Data Provenance: Not applicable.

3. Number of experts used to establish ground truth and qualifications:
* Number of Experts/Qualifications: Not applicable, as there is no diagnostic AI component requiring ground truth for interpretation.

4. Adjudication method for the test set:
* Adjudication Method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
* MRMC Study: No, this is a hardware device.

6. If a standalone (algorithm only) performance was done:
* Standalone Performance: No, this is a hardware device.

7. The type of ground truth used:
* Ground Truth: Not applicable.

8. The sample size for the training set:
* Training Set Sample Size: Not applicable.

9. How the ground truth for the training set was established:
* Training Set Ground Truth Establishment: Not applicable.

Ask a specific question about this device