← Product Code [OLT](/productcode/OLT) · K261712

# Ceribell EEG Analysis Software (K261712)

_Ceribell, Inc. · OLT · Sep 16, 2026 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261712

## Device Facts

- **Applicant:** Ceribell, Inc.
- **Product Code:** [OLT](/productcode/OLT.md)
- **Decision Date:** Sep 16, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1400
- **Device Class:** Class 2
- **Review Panel:** Neurology
- **Attributes:** Software as a Medical Device, Real-World Evidence, Pediatric

## Real-World Evidence

| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
| --- | --- | --- | --- | --- | --- |
| K261712 · Sep 16, 2026 | Ceribell EEG Analysis Software | Ceribell, Inc. | Retrospective hospital EEG recordings | Retrospective clinical EEG data were used to validate the performance of the aEEG and Burst Suppression Detection algorithms against established signal processing methods and expert neurologist review. | Retrospective clinical data; EEG recordings; Algorithm validation |

### Clinical Evidence

| Study Design | Population | Comparator | Key Endpoints |
| --- | --- | --- | --- |
| Retrospective validation | 61 patients (neonate through adult) receiving EEG monitoring in a hospital environment; Sample Size: 61 patients; Number of Sites: 4 | Legally marketed device (Persyst) | aEEG trend output equivalence |
| Retrospective validation | 1,362 subjects (ages 1 year and older); Sample Size: 1,362 subjects | encevis (predicate device) | Sensitivity, Specificity, PPV, NPV |

## Indications for Use

The Ceribell EEG Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid in the assessment of EEG. This device is intended to be used by qualified clinical practitioners who will exercise professional judgment in using the information. The included calculation and display of a set of quantitative measures is intended to monitor and analyze the EEG waveform. These include frequency band metrics and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. The included aEEG functionality is intended to monitor the state of the brain.

## Device Story

Ceribell EEG Analysis Software processes EEG data acquired from Ceribell recording devices; computes quantitative EEG (qEEG) metrics including frequency band metrics (Alpha-Delta Ratio, Relative Alpha), burst suppression (BSR, IBI), and amplitude-integrated EEG (aEEG) trends. Operates as an integrated module within the Ceribell platform in professional healthcare facilities; used by qualified clinical practitioners. Software identifies and displays trends/segments for clinician review; output serves as an aid to clinical assessment. Clinicians interpret quantitative measures alongside original EEG waveforms to monitor brain state and identify burst suppression patterns. Benefits include objective quantification of EEG features to support clinical decision-making in acute-care environments.

## Clinical Evidence

Bench testing and performance validation using 231 EEG recordings for frequency metrics and 61 patients for aEEG. Burst suppression detection validated on 1,362 subjects (ages 1+). Performance metrics for burst suppression: Sensitivity 93.04% (95% CI: 85.4-97.4%), Specificity 98.27% (95% CI: 97.1-99.0%), PPV 85.15%, NPV 99.25%. Comparison to predicate (encevis) and reference (Persyst) showed equivalent performance (r=0.978 for aEEG). No clinical prospective/retrospective trials on patient outcomes reported.

## Technological Characteristics

Software-based EEG analysis module. Deterministic logic for qEEG (frequency bands, burst suppression) and aEEG. Integrated into Ceribell platform. No hardware components. Software verification/validation per FDA guidance. Connectivity: Integrated with Ceribell EEG recording system.

## Regulatory Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

## Predicate Devices

- encevis ([K240993](/device/K240993.md))

## Reference Devices

- Persyst (aEEG trend)

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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**FDA** U.S. FOOD & DRUG
ADMINISTRATION

September 16, 2026

Ceribell, Inc.
Raymond Woo, CTO
360 N. Pastoria Ave.
Sunnyvale, California 94085

Re: K261712

Trade/Device Name: Ceribell EEG Analysis Software
Regulation Number: 21 CFR 882.1400
Regulation Name: Electroencephalograph
Regulatory Class: Class II
Product Code: OLT, OMA
Dated: August 17, 2026
Received: August 17, 2026

Dear Raymond Woo:

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K261712 - Raymond Woo

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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K261712 - Raymond Woo

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Sincerely,

Patrick Antkowiak -S

Patrick Antkowiak

Assistant Director

DHT5A: Division of Neurosurgical,  
Neurointerventional, and  
Neurodiagnostic Devices

OHT5: Office of Neurological and Physical Medicine Devices

Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# **Indications for Use**

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known)
K261712

Device Name
Ceribell EEG Analysis Software

Indications for Use (Describe)

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

The included calculation and display of a set of quantitative measures is intended to monitor and analyze the EEG waveform. These include frequency band metrics and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

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

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)

☐ Over-The-Counter Use (21 CFR 801 Subpart C)

**CONTINUE ON A SEPARATE PAGE IF NEEDED.**

This section applies only to requirements of the Paperwork Reduction Act of 1995.

**\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."*

FORM FDA 3881 (8/23)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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ceribell®

# Traditional 510(k) Summary – K261712

1. SUBMITTER

Ceribell, Inc.
360 North Pastoria Avenue
Sunnyvale, California 94085

Contact Person: Raymond Woo, PhD
Chief Technical Officer
Telephone: (800) 436-0826
E-mail: ray@ceribell.com

Alternative Contact: Angela Lynch
Regulatory Affairs Manager
E-mail: angela.lynch@ceribell.com

Date Prepared: September 15, 2026

2. DEVICE

Trade Name: Ceribell EEG Analysis Software
Common Name: Non-Normalizing Quantitative Electroencephalograph Software
Classification: Electroencephalograph (21 CFR 882.1400)
Device Class: II
Product Code: OLT, OMA

3. PREDICATE DEVICES

encevis, K240993

4. DEVICE DESCRIPTION

The Ceribell EEG Analysis Software is intended for analyzing EEG data acquired from Ceribell EEG recording devices to aid qualified clinical practitioners in the review of EEG data. In particular, the subject device is intended to compute and display qEEG and aEEG trends and identify sections of EEG that may correspond to burst suppression.

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## 5. INDICATIONS FOR USE

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

The included calculation and display of a set of quantitative measures is intended to monitor and analyze the EEG waveform. These include frequency band metrics and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms.

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

## 6. COMPARISON OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Compared to the predicate device, the subject device has the same intended use. The following table summarizes the substantial equivalence comparison between the subject device and the predicate devices.

|  Attribute | Primary Predicate Device encevis (K240993) | Subject Device Ceribell EEG Analysis Software  |
| --- | --- | --- |
|  Product Codes | OMB, OLT, OMA | OLT, OMA  |
|  Indications for Use Statement | (Note: Only relevant portions to which the subject device is claiming SE in the predicate device's Indications for Use Statement are replicated here for comparison; the subject device does not include any automatic seizure or spike detection functions and is claiming a subset of functions compared to the predicate device) 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. 4. encevis includes the calculation and display of a set of quantitative measures intended to | The Ceribell EEG Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid in the assessment of EEG. This device is intended to be used by qualified clinical practitioners who will exercise professional judgment in using the information. The included calculation and display of a set of quantitative measures is intended to monitor and analyze the EEG waveform. These include frequency band metrics and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. The included aEEG functionality is intended  |

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|  Attribute | Primary Predicate Device encevis (K240993) | Subject Device Ceribell EEG Analysis Software  |
| --- | --- | --- |
|   | 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. | to monitor the state of the brain.  |
|  Full IFU Statement Comparison (both devices are intended for Rx-only type of use) | 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. | The Ceribell EEG Analysis Software is intended for the review, monitoring and analysis of EEG recordings made by electroencephalogram (EEG) devices using scalp electrodes and to aid in the assessment of EEG. This device is intended to be used by qualified clinical practitioners who will exercise professional judgment in using the information. The included calculation and display of a set of quantitative measures is intended to monitor and analyze the EEG waveform. These include frequency band metrics and burst suppression. These quantitative EEG measures should always be interpreted in conjunction with review of the original EEG waveforms. The included aEEG functionality is intended to monitor the state of the brain.  |

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|  Attribute | Primary Predicate Device encevis (K240993) | Subject Device Ceribell EEG Analysis Software  |
| --- | --- | --- |
|   | 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 |   |

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|  Attribute | Primary Predicate Device encevis (K240993) | Subject Device Ceribell EEG Analysis Software  |
| --- | --- | --- |
|   | 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. |   |
|  EEG Analysis Functions | - *Seizure Detection* | - *Quantitative EEG measures*  |

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|  Attribute | Primary Predicate Device encevis (K240993) | Subject Device Ceribell EEG Analysis Software  |
| --- | --- | --- |
|   | - Spike Detection - Electrographic Status Epilepticus Detection - Quantitative EEG measures - Amplitude Integrated EEG (aEEG) | - Amplitude Integrated EEG (aEEG)  |
|  Device Output: Notifications / Display | On-screen display and external interface notifications for detection features. | Trends and detected segments displayed on the qEEG Recording View of the Ceribell Platform; user-customizable channel and hemispheric views.  |
|  Algorithm Description | - Quantitative EEG measures: deterministic logic to calculate pre-defined quantitative EEG metrics. - Amplitude Integrated EEG (aEEG): deterministic logic to calculate pre-defined amplitude integrated EEG metrics. | - Quantitative EEG measures: deterministic logic to calculate pre-defined quantitative EEG metrics. - Amplitude Integrated EEG (aEEG): deterministic logic to calculate pre-defined amplitude integrated EEG metrics.  |
|  Patient Population | - Seizure Detection: greater than or equal to 18 years - Spike Detection: greater than or equal to 18 years - Electrographic Status Epilepticus Detection: greater than or equal to 18 years - Quantitative EEG measures: no age limitation - Amplitude Integrated EEG (aEEG): no age limitation | - Quantitative EEG measures: no age limitation - Amplitude Integrated EEG (aEEG): no age limitation  |
|  EEG Acquisition Hardware / Platform | Vendor neutral software compatible with multiple third-party EEG systems. | Integrated module for the Ceribell System.  |
|  Intended Location of Use | Professional healthcare facilities | Professional healthcare facilities  |

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## 7. NON-CLINICAL TESTING

Software verification and validation testing was conducted, and documentation provided as recommended by FDA Guidance for Industry and FDA Staff, “*Content of Premarket Submissions for Device Software Functions.*”

Software verification and validation activities support the safety and effectiveness of the Ceribell EEG Analysis Software.

## 8. PERFORMANCE DATA

The following clinical performance data were submitted to support a determination of substantial equivalence:

### Frequency Band Metrics

The Alpha-Delta Ratio (ADR) and Relative Alpha (RA) modules are validated using a dataset of 231 EEG recordings collected by both the Ceribell EEG system as well as by conventional EEG devices. To evaluate the performance of the algorithms, sinusoidal waves with known ADR/RA were artificially generated and the respective algorithm outputs were compared against the known ADR/RA of these artificial waves. The algorithms were further tested by comparison against an established signal processing tool on real EEG data. The relative percent difference and Pearson’s correlation coefficient across all test cases was $\leq 10\%$ and $\geq 0.8$, respectively. These results confirm the algorithms meet all performance requirements to accurately calculate ADR and RA from EEG.

### Amplitude-Integrated EEG (aEEG)

The aEEG module is validated using EEG recordings from a total of 61 patients (aged from neonate through adult) who received EEG monitoring within the hospital environment, at four distinct sites. Performance of the aEEG algorithm was validated by utilizing an established signal processing method to verify equivalent performance and comparing its’ aEEG trend output to a legally marketed device. Testing confirmed the Ceribell aEEG algorithm Asymmetrical filters’ frequency response is equivalent to that of the reference ($r=0.978$; $PD=-0.92$) and the upper and lower margins of Ceribell aEEG trend are equivalent to Persyst’s aEEG trend. These results confirm that the algorithm effectively generate an aEEG trend and has demonstrated clinical performance that is adequate to meet the intended use.

### Device Performance

Performance against the acceptance criteria was assessed, acceptance criteria were met, and the aEEG algorithm passes. The results the comparison of Ceribell vs. Persyst aEEG trends are shown in the following table:

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|  Performance Measure | Left / Right Hemispheres | Result | 95% CI | Acceptance Criteria | PASS/FAIL  |
| --- | --- | --- | --- | --- | --- |
|  $\rho_U$ | Left | 0.995 | [0.99, 1.00] | $\geq 0.8$ | PASS  |
|   |  Right | 0.994 | [0.99, 1.00] | $\geq 0.8$ | PASS  |
|  $\rho_L$ | Left | 0.994 | [0.99, 1.00] | $\geq 0.8$ | PASS  |
|   |  Right | 0.994 | [0.99, 1.00] | $\geq 0.8$ | PASS  |
|  $RPD_U$ | Left | 5.712 | [5.26, 6.16] | $\leq 10\%$ | PASS  |
|   |  Right | 5.690 | [5.28, 6.10] | $\leq 10\%$ | PASS  |
|  $RPD_L$ | Left | 5.489 | [5.08, 5.90] | $\leq 10\%$ | PASS  |
|   |  Right | 5.496 | [5.14, 5.86] | $\leq 10\%$ | PASS  |

### Burst Suppression Detection & Pattern Characteristics

The Burst Suppression Detection module is validated by evaluating the performance of the detection algorithm through the analysis of clinically collected EEG data and the computations of quantitative measures of discontinuities in the EEG, namely BSR and IBI. The algorithm was validated using a robust, independent dataset of 1,362 subjects (ages 1 year and older) to ensure the algorithm's performance is representative of the intended patient population. The reference standard for the validation dataset was determined through expert review by EEG trained neurologists trained to detect burst suppression in EEG data. The minimum performance criteria are set based on the performance of the comparator device, encevis. The algorithm met all acceptance criteria for Sensitivity (SE), Specificity (SP), Positive Predictive Value (PPV), and Negative Predictive Value (NPV). This demonstrates the detection algorithm's reliability in identifying clinically significant burst suppression patterns.

### Device Performance

Performance against the acceptance criteria was assessed. In the overall dataset, the acceptance criteria were met and the Burst Suppression Detection algorithm passes. The detailed results for performance metrics are shown in the following table:

|  Metric | Value | 95% CI | Conformance to Acceptance Criteria  |
| --- | --- | --- | --- |
|  **Sensitivity** | 93.04% | [85.434, 97.391] | 93.04% $\geq$ 87%, therefore, PASS  |
|  **Specificity** | 98.27% | [97.097, 98.965] | 98.27% $\geq$ 92%, therefore, PASS  |
|  **PPV** | 85.15% | [72.009, 93.316] | 85.15% $\geq$ 61%, therefore, PASS  |
|  **NPV** | 99.25% | [98.158, 99.739] | 99.25% $\geq$ 98%, therefore, PASS  |

Additionally, EEG signals with known BSR and IBI were generated artificially and the calculation results from the algorithm were compared against known ground truth using Percent Difference (PD) which quantifies the disparity between ground truth values and calculated values. The mean PD for BSR and IBI was 0.88% and 0.049%, respectively.

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These results confirm the algorithm correctly computes the quantitative metrics of BSR and IBI.

## 9. SUMMARY

The Ceribell EEG Analysis Software has the same intended use as the predicate device. In addition, it has similar technological characteristics, clinical workflow, and underlying operating principles. Differences within the EEG Analysis Software have been validated through performance testing. Therefore, the Ceribell EEG Analysis Software is substantially equivalent to the cleared predicate device.

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**Source:** [https://fda.innolitics.com/device/K261712](https://fda.innolitics.com/device/K261712)

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