(120 days)
Not Found
Yes
The description mentions a "Seizure Detection software module" that "assists qualified users in reviewing and annotating EEG by marking previously acquired sections of EEG that may correspond to electrographic seizures." The validation section describes a "validation dataset... completely separate and independent from the data used to design and train the algorithm," strongly implying the use of a trained algorithm, which is characteristic of ML.
No.
The device is intended to record and present EEG signals for diagnostic assistance rather than directly treating a condition.
No
The text explicitly states: "The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert." While it assists medical staff in making diagnoses and assessing EEG traces, it does not provide a diagnosis itself.
No
The device description explicitly lists hardware components such as the "Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system," a power adapter, and a micro-USB cable. While it includes software components, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Device Function: The Ceribell Pocket EEG Device records and presents EEG signals directly from the patient's scalp. This is a non-invasive procedure that measures electrical activity within the brain. It does not involve analyzing samples taken from the body.
- Intended Use: The intended use is to assist trained medical staff in making neurological diagnoses by providing visual and audible representations of EEG signals and marking potential electrographic seizures. This is a diagnostic aid based on real-time physiological measurements, not laboratory analysis of biological samples.
Therefore, the Ceribell Pocket EEG Device falls under the category of a medical device that performs physiological measurements, not an in vitro diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The Ceribell Pocket EEG Device is intended to record and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.
Additionally, the EEG Recording Viewer Software component of the Pocket EEG Device incorporates a Seizure Detection component that is intended to mark previously acquired sections of EEG recordings in patients greater than or equal to 18 years of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection component provides notifications to the user when detected seizure prevalence is "Frequent," "Abundant," or "Continuous," per the definitions of the American Clinical Neurophysiology Society Guideline 14. Notifications include an on-screen display on the Pocket EEG Device and the optional sending of an e-mail message to a clinician. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.
The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
Product codes
OMB, OMC, GWQ
Device Description
The Ceribell Pocket EEG Device is a previously cleared EEG monitoring system which includes a portable 8-channel system that is being upgraded in this 510(k) notification K191301 to include a seizure detection module. The device connects to 10 patient electrodes (5 left, 5 right), which are used to form the 8 channels. The device may be used with any scalp EEG electrodes, and the system includes the following components:
-
Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system.
-
Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device. ●
-
. Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically disabled.
-
EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a ● computer. The EEG Recording Viewer Software includes a Seizure Detection software module that assists qualified users in reviewing and annotating EEG by marking previously acquired sections of EEG that may correspond to electrographic seizures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EEG
Anatomical Site
Not Found
Indicated Patient Age Range
patients greater than or equal to 18 years of age
Intended User / Care Setting
trained medical staff, qualified clinical practitioners, professional healthcare facility environment
Description of the training set, sample size, data source, and annotation protocol
A validation dataset of full montage EEG recordings obtained from adult (18 years and older) patients were chosen for validation testing. This dataset was completely separate and independent from the data used to design and train the algorithm.
Description of the test set, sample size, data source, and annotation protocol
The validation dataset was obtained from previous studies that retrospectively reviewed all adult EEGs from patients who underwent inpatient EEG monitoring over a period of time. Data from one hospital was used for ICU EEG data, and data from a second hospital was used for EMU EEG data. From the ICU and EMU source datasets, a total of 60 subjects aged 18 or older were randomly selected for inclusion in the Ceribell seizure detection validation study; 30 from the ICU dataset and 30 from the EMU dataset.
A reference standard was established for the validation dataset by EEG trained neurologists who reviewed and annotated the EEG recordings for seizure episodes.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical and Clinical Performance Data.
Sample Size: 60 subjects for clinical performance data.
Key Metrics: PPA and FP/hr.
Standalone Performance:
For "Frequent" notifications: PPA = 94.67% (95% CI: 90.00%, 97.33%), FP/hr = 0.2145 (95% CI: 0.119, 0.351).
For "Abundant" notifications: PPA = 93.02% (95% CI: 81.39%, 100%), FP/hr = 0.1996 (95% CI: 0.093, 0.381).
For "Continuous" notifications: PPA = 91.30% (95% CI: 78.26%, 100%), FP/hr = 0.1247 (95% CI: 0.054, 0.272).
Key Results:
The validation protocol required that the PPA and FP/hr for the Ceribell "Frequent" notification output must be statistically non-inferior to the Persyst 13 seizure detection notification output. Validation was based upon demonstrating that Ceribell was non-inferior to Persyst 13 with a 10% non-inferiority Margin. The criteria for minimally acceptable device performance was to have a positive percent agreement with a 95% CI lower bound above 70% and a false positive rate with a 95% CI upper bound below 0.446 per hour. All three Ceribell seizure notification levels ("Frequent," "Abundant," and "Continuous") met the acceptance criteria for both PPA and FP/hr. The percentage agreement for the three notification levels ranged from 91.30% to 94.67%, and the false positive rate ranged from 0.1247 to 0.2145.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement (PPA)
False Positives per hour (FP/hr)
Sensitivity (for "Abundant" notification: 90.0% for Seizure Duration 150 seconds, 95.6% for Seizure Duration >= 270 seconds, Total 93.02%)
Sensitivity (for "Continuous" notification: 91.3% for Seizure Duration >= 270 seconds, Total 91.3%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.1400 Electroencephalograph.
(a)
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.(b)
Classification. Class II (performance standards).
0
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Ceribell, Inc. Josef Parvizi Chairman 2483 Old Middlefield Way, Suite 120 Mountain View, California 94043
Re: K191301
Trade/Device Name: Ceribell Pocket EEG Device Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB, OMC, GWQ Dated: May 13, 2019 Received: May 14, 2019
Dear Josef Parvizi:
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 (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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely,
Jay Gupta 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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Indications for Use
510(k) Number (if known) K191301
Device Name Ceribell Pocket EEG Device
Indications for Use (Describe)
The Ceribell Pocket EEG Device is intended to record and to present the EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Device is intended to be used in a professional healthcare facility environment.
Additionally, the EEG Recording Viewer Software component of the Pocket EEG Device incorporates a Seizure Detection component that is intended to mark previously acquired sections of EEG recordings in patients greater than or equal to 18 years of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The Seizure Detection component provides notifications to the user when detected seizure prevalence is "Frequent," "Abundant," or "Continuous," per the definitions of the American Clinical Neurophysiology Society Guideline 14. Notifications include an on-screen display on the Pocket EEG Device and the optional sending of an e-mail message to a clinician. Delays of up to several minutes can occur between the beginning of a seizure and when the Seizure Detection notifications will be shown to a user.
The Pocket EEG Device does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
| 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) |
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K191301 510(k) Summary
This 510(k) summary was prepared on 9/11/2019 to provide an understanding of the basis for a determination of substantial equivalence in accordance with the requirements outlined in 21 CFR 807.92.
Submitter Information
Ceribell, Inc. 2483 Old Middlefield Way Suite 120 Mountain View, California 94043 1(800)436-0826
Contact Person
Dr. Josef Parvizi, MD, PhD Chairman Telephone: (650) 521-7003 E-mail: josef@ceribell.com
Subject Device Information
| Trade Name: | Ceribell Pocket EEG Device |
|---|---|
| Classification Name: | Electroencephalograph |
| Regular Description: | EEG or Electroencephalograph |
| Device Class: | Class II; 882.1400 |
| Product Code: | OMB |
| OMB Device: | Automatic Event Detection Software for Full-Montage Electroencephalograph |
| Additional Pro Codes: | OMC, GWQ (full-montage standard electroencephalograph) |
Predicate Device
| Primary Predicate: | K170363
Ceribell Pocket EEG Device
882.1400, OMC (reduced- montage standard electroencephalograph), GWQ |
|---------------------|--------------------------------------------------------------------------------------------------------------------|
| Secondary Predicate | K151929
Persyst 13 (P13)
882.1400, OMB, OLT (non-normalizing quantitative electroencephalograph
software) |
Device Description
The Ceribell Pocket EEG Device is a previously cleared EEG monitoring system which includes a portable 8-channel system that is being upgraded in this 510(k) notification K191301 to include a seizure detection module. The device connects to 10 patient electrodes (5 left, 5 right), which are used to form the 8 channels. The device may be used with any scalp EEG electrodes, and the system includes the following components:
- Pocket EEG Device: a portable, battery powered, 8-channel EEG monitoring system.
- Power adapter: 100-240 V AC power adapter used to charge the Pocket EEG Device. ●
- . Micro-USB cable: cable used to connect Pocket EEG Device to power adapter for charging and to connect to a computer to transfer EEG recording files. When the Pocket EEG Device is connected to a power adapter of a computer, all EEG acquisition functions are automatically
4
disabled.
- EEG Recording Viewer Software: EEG review software for viewing EEG recordings on a ● computer. The EEG Recording Viewer Software includes a Seizure Detection software module that assists qualified users in reviewing and annotating EEG by marking previously acquired sections of EEG that may correspond to electrographic seizures.
Intended Use
The Ceribell Pocket EEG Device is a portable EEG monitoring system that records, stores and presents EEG signals in visual and audible formats in real time. The visual and audible signals assist trained medical staff to make neurological diagnoses. The Pocket EEG Recording Viewer software incorporates a Seizure Detection component that is intended to mark previously acquired sections of EEG recordings in patients greater than or equal to 18 years of age that may correspond to electrographic seizures in order to assist qualified clinical practitioners in the assessment of EEG traces. The device does not provide any diagnostic conclusion about the subject's condition and Seizure Detection notifications cannot be used as a substitute for real time monitoring of the underlying EEG by a trained expert.
| Table 1: Comparison of Indications for Use | ||
|---|---|---|
| Subject Device K191301 (Rx only) | Predicate K170363 (Rx only) | Predicate K151929 (Rx only) |
| The Ceribell Pocket EEG Device is | ||
| intended to record and store EEG | ||
| signals, and to present the EEG signals in | ||
| visual and audible formats in real time. | ||
| The visual and audible signals assist | ||
| trained medical staff to make | ||
| neurological diagnoses. The Pocket EEG | ||
| Device is intended to be used in a | ||
| professional healthcare facility | ||
| environment. | ||
| Additionally, the EEG Recording Viewer | ||
| Software component of the Pocket EEG | ||
| Device incorporates a Seizure Detection | ||
| component that is intended to mark | ||
| previously acquired sections of EEG | ||
| recordings in patients greater than or | ||
| equal to 18 years of age that may | ||
| correspond to electrographic seizures in | ||
| order to assist qualified clinical | ||
| practitioners in the assessment of EEG | ||
| traces. The Seizure Detection component | ||
| provides notifications to the user when | ||
| detected seizure prevalence is | ||
| "Frequent," "Abundant," or | ||
| "Continuous," per the definitions of the | ||
| American Clinical Neurophysiology | ||
| Society Guideline 14. Notifications | ||
| include an on-screen display on the | ||
| Pocket EEG Device and the optional | ||
| sending of an e-mail message to a | ||
| clinician. Delays of up to several minutes | ||
| can occur between the beginning of a | ||
| seizure and when the Seizure Detection | ||
| notifications will be shown to a user. | The Ceribell Pocket EEG Device is | |
| intended to record and store EEG | ||
| signals, and to present the EEG | ||
| signals in visual and audible | ||
| formats in real time. The visual and | ||
| audible signals assist trained | ||
| medical staff to make neurological | ||
| diagnoses. The Pocket EEG Device | ||
| does not provide any diagnostic | ||
| conclusion about the subject's | ||
| condition and does not provide any | ||
| automated alerts of an adverse | ||
| clinical event. The Pocket EEG | ||
| Device is intended to be used in a | ||
| professional healthcare facility | ||
| environment. | 1. Persyst 13 EEG Review and Analysis | |
| Software 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. |
- The Seizure Detection component of
Persyst 13 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. - The Spike Detection component of Persyst
13 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 patients at least one month old.
Persyst 13 Spike Detection performance
has not been assessed for intracranial
recordings. - Persyst 13 includes the calculation and
display of a set of quantitative measures
intended to monitor and analyze the EEG
waveform. These include FFT. |
5
Comparison of Intended Use and Technological Characteristics with Predicates K170363 & K151929
The subject device and predicate K170363 Ceribell Pocket EEG Device share intended use as a portable EEG monitoring system that records, stores, and presents EEG signals in visual and audible formats. The recorded EEG signals assist trained medical staff to make neurological diagnoses. The subject device and K170363 are identical with exception of the modification to introduce the EEG Recording Viewer Software to K170363 in order to include an additional Seizure Detection software module.
The subject device and K151929 Persyst 13 (P13) share the same intended use for analyzing EEG files to identify possible seizure episodes and then mark previously acquired sections of adult EEG. The subject
6
device and K151929 differ only by the number of patient electrodes used for seizure detection, the manner of the presentation of seizure detection output, and the types of seizure detection notifications provided.
Non-clinical Performance Data
The following non-clinical performance data were submitted to support a determination of substantial equivalence:
- IEC 60601-1:2005+A1:2012, edition 3.1, Medical electrical equipment Part 1: 1. General requirements for basic safety and essential performance. This test report also includes national differences testing to the FDA recognized consensus standard, ANSI/AAMI ES60601- 1:2005+A1:2012, C1:2009, A2:2010.
-
- IEC 60601-2-26:2012, edition 1.0, Medical electrical equipment - Part 2-26: Requirements for the basic safety and essential performance of electroencephalographs.
- IEC 60601-1-6:2010+A1:2013, edition 3.1, Medical electrical equipment Part 1-6: 3. General requirements for basic safety and essential performance - Collateral standard: Usability.
-
- IEC 62366:2007, edition 1.0, Medical devices - Application of usability engineering to medical devices.
-
- IEC 62133:2012, edition 2.0, Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary sells, and for batteries made from them, for use in portable applications.
- IEC 60601-1-2:2007, edition 3.0: Medical electrical equipment Part 1-2: General 6. requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility. The table below compares the Wi-Fi modules between K170363 and K191301. The subject device Wi-Fi communications module has been upgraded to a more recent version within the same family; the new Wi-Fi module is the ST Microelectronics model SPWF04SA, the previous module in the predicate device was the ST Microelectronics model SPWF01SA. There are no other hardware differences between the subject device and the predicate Pocket EEG Device of K170363.
7
| Table 2: Specifications of Previous and Updated Wi-Fi Modules | ||
|---|---|---|
| Predicate Device (K170363) Module | ||
| ST Microelectronics SPWF01SA | Subject Device (K191301) Module | |
| ST Microelectronics SPWF04SA | ||
| WiFi frequency/standard | 2.4 GHz IEEE 802.11 b/g/n | 2.4 GHz IEEE 802.11 b/g/n |
| Transmit power | 18.3 dBm @ 1 Mbps DSSS | |
| 13.7 dBm @ 54 Mbps OFDM | 18.3 dBm @ 1 Mbps DSSS | |
| 13.7 dBm @ 54 Mbps OFDM | ||
| Receive sensitivity | -96.0 dBm @ 1 Mbps DSSS | |
| -74.5 dBm @ 54 Mbps OFDM | -96.0 dBm @ 1 Mbps DSSS | |
| -74.5 dBm @ 54 Mbps OFDM | ||
| Antenna type | Integrated | Integrated |
| Form factor/dimensions | Surface mount PCB module | |
| 26.92 x 15.24 x 2.35 mm | Surface mount PCB module | |
| 26.92 x 15.24 x 2.35 mm | ||
| Integrated processor and | ||
| memory | STM32 ARM Cortex-M3 processor | |
| with 64 kB RAM | STM32 ARM Cortex-M4 processor | |
| with 256 KB RAM | ||
| FCC approval | Full modular approval | |
| FCC ID: VRA-SG9011203 | Full modular approval | |
| FCC ID: S9NSPWFS04 |
Clinical Performance Data
The following clinical performance data were submitted to support a determination of substantial equivalence:
Demographics
The demographics of Ceribell's seizure detection validation dataset are as follows:
| Table 3: Seizure Detection Validation Dataset Demographics | |
|---|---|
| Total subjects | 60 |
| Gender | Male: 29 (48.3%) |
| Female: 31 (51.7%) | |
| Age | Average: 56.5 |
| Minimum: 22 | |
| Maximum: 88 |
Patient Baseline Characteristics
The validation dataset had no inclusion/exclusion criteria related to patient baseline characteristics. In general, ICU patients who receive EEG monitoring present with one or more neurological diagnoses that are potentially indicate an increased risk of seizures. EMU patients typically have a prior history of seizures that warrants EEG monitoring.
Enrollment
The validation dataset was obtained from previous studies that retrospectively reviewed all adult EEGs from patients who underwent inpatient EEG monitoring over a period of time. Data from one hospital was used for ICU EEG data, and data from a second hospital was used for EMU EEG data. From the ICU and EMU source datasets, a total of 60 subjects aged 18 or older were randomly selected for inclusion in the Ceribell seizure detection validation study; 30 from the ICU dataset and 30 from the EMU dataset.
Masking
All of the EEG data used for Ceribell's seizure detection vas retrospectively obtained from pre-existing EEG databases. The EEG trained neurologists who reviewed the data to provide the clinical reference were masked. The EEGs used for the validation protocol were selected with
8
no knowledge of how the Ceribell or Persyst 13 seizure detection would perform. No patients from the validation dataset were used for algorithm training or development.
General Summary
The following is a summary of the validation procedure performed:
- A validation dataset of full montage EEG recordings obtained from adult (18 years and older) . patients were chosen for validation testing. This dataset was completely separate and independent from the data used to design and train the algorithm.
- A reference standard was established for the validation dataset by EEG trained neurologists ● who reviewed and annotated the EEG recordings for seizure episodes.
- . Both Ceribell Pocket EEG Device and predicate Persyst 13 (K151929) Seizure Detection modules were run on the validation dataset and performance metrics were calculated for each as compared to the reference standard established per above.
- Statistical analysis was performed on the results to evaluate and compare the performance to the ● predetermined acceptance criteria.
Selection of Validation Sets
The validation was performed as a retrospective analysis of EEG data gathered from patients in the Intensive Care Unit (ICU) and Epilepsy Monitoring Unit (EMU). These two locations are representative of EEGs taken throughout the hospital environment and thus reflect the intended use of the subject device.
For the validation data set, 50% of the data was from the ICU and 50% was from the EMU. The reference standard for the validation data set was obtained by having trained experts review and annotate the EEG files for onset and conclusion of seizure episodes.
The expert EEG reviewers used to generate the reference standard were affiliated with multiple different institutions. All were fellowship trained in epilepsy or clinical neurophysiology. To validate seizure detection notifications, positive percent agreement (PPA) and false positives/ hour (FP/hr) were calculated for the Ceribell Seizure Detection module and Persyst 13 with respect to the reference standard.
The three levels of seizure detection notification for Ceribell ("Frequent," "Abundant," and "Continuous") are additive – the "Frequent" notification must always occur first before the "Abundant" or "Continuous" notification. Therefore, it is most relevant to compare the Ceribell "Frequent" notification output to the Persyst 13 seizure notification output. The Ceribell "Frequent" notification output represents the detection of 30 seconds or more of seizure activity within a 5-minute moving window. The Persyst 13 seizure notification output represents the detection of 11 seconds or more of continuous seizure activity. There is no clinically relevant distinction between these two types of notifications. The validation protocol requires that the PPA and FP/hr for the Ceribell "Frequent" notification output must be statistically non-inferior to the Persyst 13 seizure detection notification output. Additionally, to assess device effectiveness and clinical utility, performance of all Ceribell's notification levels, "Frequent," "Abundant," and "Continuous," with respect to the reference standard are calculated and presented with the results along with their 95% confidence intervals. The criteria for minimally acceptable device performance was to have a positive percent agreement with a 95% CI lower bound above 70% and a false positive rate with a 95% CI upper bound below 0.446 per hour.
Page 6 of 9
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Validation was based upon demonstrating that Ceribell was non-inferior to Persyst 13 with a 10% noninferiority Margin.
Results of Clinical Performance Testing
| Table 4: Contingency Table of Ceribell Device Output For "Abundant" Notification With Respect To Clinical Reference For
| The Validation Dataset | |||||
|---|---|---|---|---|---|
| Clinical Reference | |||||
| (Review and Annotation of validation datasets by EEG-trained neurologists) | |||||
| No seizure or Seizure | |||||
| Duration 70%, | |||||
| therefore, PASS | 0.2145 | [0.119, 0.351] | 0.351 70%, | ||
| therefore, PASS | 0.1996 | [0.093, 0.381] | 0.381 70%, | ||
| therefore, PASS | 0.1247 | [0.054, 0.272] | 0.272 |