The Ceribell Status Epilepticus Monitor software is indicated for the diagnosis of Electrographic Status Epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The Ceribell Status Epilepticus Monitor software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epileptious as defined in the American Clinical Neurophysiology Society's Guideline 14.

The diagnostic output of the Ceribell Status Epilepticus Monitor is intended to be used as an aid for determining patient treatment in acute-care environments. The device's diagnosis of Electrographic Status Epilepticus provides 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 Ceribell Status Epilepticus Monitor is intended for diagnosis of Electrographic Status Epilepticus only. The device 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 device is not intended for use in Epilepsy Monitoring Units.

Device Description

The Ceribell Status Epilepticus Monitor is a software as medical device that analyzes EEG waveforms for the intended use of recognizing electrographic status epilepticus (ESE). The subject device software is intended for use only with the Ceribell Pocket EEG Device (K191301), which is also the predicate device. The predicate device contains a software module that performs detection of seizures in a similar manner as the subject device. The user workflow and instructions for starting an EEG recording on a patient are unchanged compared to the predicate device.

The user places the Ceribell Instant EEG Headband (K210805) on the patient, the headband contains 10 electrodes that are arranged in a bipolar montage and correspond to the following locations following the 10-20 electrode naming convention: Fp1, F7, T3, T5, O1, Fp2, F8, T3, T6, O2. The 10 electrodes form 8 channels (4 on the left hemisphere, 4 on the right hemisphere) that are analyzed by the subject device's ESE detection algorithm.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

The Ceribell Status Epilepticus Monitor underwent clinical validation to assess its performance in diagnosing Electrographic Status Epilepticus (ESE). The primary performance metrics were sensitivity and specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Measure	Acceptance Criteria (Implied)	Reported Device Performance
Sensitivity	High sensitivity for ESE detection to minimize false negatives and ensure timely treatment. Specific quantitative acceptance criteria were not explicitly stated as numerical thresholds (e.g., "X% sensitivity") but the document emphasizes "100% sensitive" for this aspect.	100%
Specificity	Sufficient specificity to avoid unnecessary treatment in ESE-negative cases. Specific quantitative acceptance criteria were not explicitly stated as numerical thresholds.	94%

2. Sample Size for the Test Set and Data Provenance

Sample Size: 350 subjects
Data Provenance: Retrospective study using previously-collected EEG data from 6 hospitals of varying size and geographic locations. The data represents "real-world data" from a fixed one-year time period. All included subjects were ≥ 18 years of age.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: A team of "qualified neurologists" (specific number not given, but plural).
Qualifications of Experts: Described as "qualified neurologists." No further details on years of experience or specific subspecialties are provided in the document.

4. Adjudication Method for the Test Set

Adjudication Method: "Majority opinion of the expert reviewers." This indicates a consensus-based approach. For example, if there were three reviewers, at least two would need to agree.

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

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as having been performed. The study focused on the standalone performance of the algorithm against expert-established ground truth.
Effect Size of Human Readers with vs. Without AI Assistance: Not applicable, as an MRMC study with human-in-the-loop performance was not described.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Yes, the study describes the standalone (algorithm-only) performance of the Ceribell Status Epilepticus Monitor. The device algorithm was run on the collected dataset, and its output was compared against the expert-established ground truth.

7. Type of Ground Truth Used

Ground Truth Type: Expert consensus. Specifically, a "team of qualified neurologists independently review[ed] and categorize[d] each EEG; the ground-truth reference standard is established by a majority opinion of the expert reviewers."

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. The clinical validation study described is a retrospective study of the algorithm's performance on a test set (350 subjects).

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

The document does not explicitly state how the ground truth for the training set was established, as details about the training phase itself are not provided in this summary. The focus is on the clinical validation study.

Summary

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May 23, 2023

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Ceribell, Inc. Raymond Woo, Ph.D. Chief Technology Officer 360 N Pastoria Ave. Sunnyvale, CA 94085

Re: K223504

Trade/Device Name: Ceribell Status Epilepticus Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB Dated: April 28, 2023 Received: April 28, 2023

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 (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

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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,

Patrick Antkowiak -S

Patrick Antkowiak, Ph.D. Acting 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) K223504

Device Name Ceribell Status Epilepticus Monitor

Indications for Use (Describe)

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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510(k) Summary

This summary of 510(k)-safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Applicant Information:

Ceribell, Inc. 360 N Pastoria Ave Sunnyvale, CA 94085

Contact Person:

Raymond Woo, Ph.D. CTO Telephone: (650) 556-4349 E-mail: ray@ceribell.com

Subject Device Information:

Trade Name:	Ceribell Status Epilepticus Monitor
Classification Name:	Electroencephalograph
Device Class:	II; 21 CFR 882.1400
Product Code:	OMB
OMB Device:	Automatic Event Detection Software for Full-Montage Electroencephalograph

Predicate Device:

K191301 Ceribell Pocket EEG Device 882.1400, OMB (automatic event detection software for full-montage electroencephalograph), OMC, GWO

Date Prepared:

May 18, 2023

Device Description:

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10-20 electrode naming convention: Fp1, F7, T3, T5, O1, Fp2, F8, T3, T6, O2. The 10 electrodes form 8 channels (4 on the left hemisphere, 4 on the right hemisphere) that are analyzed by the subject device's ESE detection algorithm. The American Clinical Neurophysiology Society's (ACNS) Guideline 14 ("Standardized Critical Care EEG Terminology: 2021 Edition") defines ESE as follows:

ESE is defined as an ESz [electrographic seizure] for ≥ 10 continuous minutes or for a total duration of ≥ 20% of any 60-minute period of recording.

By definition, ESE is a finding that is based solely on the characteristics of the subject's EEG waveforms. The are no other clinical considerations or sources of clinical information that are used in the determination of ESE. The subject device is intended for use in the recognition of ESE in acute care environments only. The absence of a detection of ESE by the subject device does not preclude the possibility that seizures, other epileptiform patterns, or other pathologies are present in the EEG recording. The device does not substitute for the review of the underlying EEG by a qualified clinician with respect to any other types of pathological EEG patterns.

Intended Use

The Ceribell Status Epilepticus Monitor is a software as medical device that is intended to analyze EEG recordings captured with the Ceribell Pocket EEG Device and the Ceribell Instant EEG Headband and diagnose electrographic status epilepticus in patients greater than or equal to 18 years of age who are at risk for seizure. The software analyzes EEG waveforms and identifies patterns that may be consistent with electrographic status epilepticus as defined in the American Clinical Neurophysiology Society's Guideline 14.

Comparison of Intended Use and Technological Characteristics with the Predicate Device:

The subject device is substantially equivalent to the seizure detection module of the predicate device in terms of intended use, operating principles, and design. The subject device and predicate devices both contain algorithms to detect electrographic seizures, and in both the subject device and predicate device the design of the electrographic seizure detection is the subject device additionally processes the electrographic seizure detections to make a determination regarding ESE. The ESE determination serves as the final output of the subject device output is binary: ESE is either detected or not detected.

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Attribute	Subject Device	Predicate Device
	Ceribell Status Epilepticus Monitor	Ceribell Pocket EEG Device (K191301)
Intended Use	The Ceribell Status Epilepticus Monitor is a software asmedical device that is intended to analyze EEG recordingscaptured with the Ceribell Pocket EEG Device and theCeribell Instant EEG Headband and diagnoseelectrographic status epilepticus in patients greater thanor equal to 18 years of age who are at risk for seizure. Thesoftware analyzes EEG waveforms and identifies patternsthat may be consistent with electrographic statusepilepticus as defined in the American ClinicalNeurophysiology Society's Guideline 14.The diagnostic output of the Ceribell Status EpilepticusMonitor is intended to be used as an aid for determiningpatient treatment in acute-care environments. Thedevice's diagnosis of Electrographic Status Epilepticusprovides one input to the clinician that is intended to beused in conjunction with other elements of clinical practiceto determine the appropriate treatment course for thepatient.The Ceribell Status Epilepticus Monitor is intended fordiagnosis of Electrographic Status Epilepticus only. Thedevice does not substitute for the review of the underlyingEEG by a qualified clinician with respect to any other typesof pathological EEG patterns. The device is not intendedfor use in Epilepsy Monitoring Units.	The Ceribell Pocket EEG Device is a portable EEG monitoringsystem that records, stores and presents EEG signals invisual and audible formats in real time. The visual andaudible signals assist trained medical staff to makeneurological diagnoses. The Pocket EEG Device EEGRecording Viewer software incorporates a seizure detectioncomponent is intended to analyze EEG recordings capturedwith the Ceribell Pocket EEG Device and identify areas thatmay correspond to electrographic seizures in patientsgreater or equal to 18 years of age. The Pocket EEG Deviceseizure detection module is not intended to provide clinicalconclusions about the subject's condition and the output ofthe seizure detection module is intended to be used byqualified clinical practitioners in coordination with otherclinical observations.
Indications forUse	The Ceribell Status Epilepticus Monitor software isindicated for the diagnosis of Electrographic StatusEpilepticus in patients greater than or equal to 18 years ofage who are at risk for seizure. The Ceribell StatusEpilepticus Monitor software analyzes EEG waveforms andidentifies patterns that may be consistent withelectrographic status epilepticus as defined in theAmerican Clinical Neurophysiology Society's Guideline 14.The diagnostic output of the Ceribell Status EpilepticusMonitor is intended to be used as an aid for determiningpatient treatment in acute-care environments. Thedevice's diagnosis of Electrographic Status Epilepticusprovides one input to the clinician that is intended to beused in conjunction with other elements of clinical practiceto determine the appropriate treatment course for thepatient.The Ceribell Status Epilepticus Monitor is intended fordiagnosis of Electrographic Status Epilepticus only. Thedevice does not substitute for the review of the underlyingEEG by a qualified clinician with respect to any other typesof pathological EEG patterns. The device is not intendedfor use in Epilepsy Monitoring Units.	The Ceribell Pocket EEG Device is intended to record andstore EEG signals, and to present the EEG signals in visualand audible formats in real time. The visual and audiblesignals assist trained medical staff to make neurologicaldiagnoses. The Pocket EEG Device is intended to be used ina professional healthcare facility environment.Additionally, the EEG Recording Viewer Softwarecomponent of the Pocket EEG Device incorporates a SeizureDetection component that is intended to mark previouslyacquired sections of EEG recordings in patients greater thanor equal to 18 years of age that may correspond toelectrographic seizures in order to assist qualified clinicalpractitioners in the assessment of EEG traces. The SeizureDetection component provides notifications to the userwhen detected seizure prevalence is "Frequent,""Abundant," or "Continuous," per the definitions of theAmerican Clinical Neurophysiology Society Guideline 14.Notifications include an on-screen display on the Pocket EEGDevice and the optional sending of an e-mail message to aclinician. Delays of up to several minutes can occur betweenthe beginning of a seizure and when the Seizure Detectionnotifications will be shown to a user.The Pocket EEG Device does not provide any diagnosticconclusion about the subject's condition and SeizureDetection notifications cannot be used as a substitute forreal time monitoring of the underlying EEG by a trainedexpert.
Intended User	Qualified healthcare professional	Qualified healthcare professional
Attribute	Subject Device	Predicate Device
	Ceribell Status Epilepticus Monitor	Ceribell Pocket EEG Device (K191301)
IntendedPatientpopulation	Patients greater or equal to 18 years of age.	All ages. The seizure detection module is intended only forpatients greater or equal to 18 years of age.
IntendedLocation of Use	Acute-care environments within professional healthcarefacilities	Professional healthcare facility

Table 1. Comparison between the subject device and predicate device.

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Performance Data:

Bench-top verification testing was performed on the subject device. The verification tests were completed in accordance with relevant standards and pre-approved protocols to evaluate the safety and performance of the subject device, and all tests were passed.

Table 2. Summary of bench-top verification testing.

Test Description	Acceptance Criteria	Test Results
ESE Monitor System Level Test:Integration and system level test that verifiesand validates the processing of ESE data and thedisplay of ESE output (ESE detected/ESE notdetected).	Various functional acceptance criteriabased on the expected behavior of thesystem.	All tests passed.
Regression Testing:Per the V&V Summary Report, several testprotocols were executed to ensure that theStatus Epilepticus Monitor did not have anyunexpected effect or cause unintendedregressions with the underlying Pocket EEGDevice software.Because these test reports do not directly verifyany of the subject device softwarerequirements, all of these regression testreports are combined into a single appendix forsimplicity.	Various functional acceptance criteriabased on the expected behavior of thesystem.	All tests passed.

Clinical Testing

A retrospective clinical validation study was performed by analyzing the subject device algorithm's performance using previously-collected EEG data. The objective of the study design was to obtain a dataset that is representative of the intended patient population, and this was accomplished by using real-world data. The methodology of data collection was as follows:

For each of 6 hospitals of varying size and geographic location: .
- Collect all clinically performed Ceribell EEGs from a fixed one-year time period o
- Exclude any EEGs from patients < 18 years of age O
- There were no other inclusion or exclusion criteria applied O

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. Categorize each subject as ESE-positive or ESE-negative by having a team of qualified neurologists independently review and categorize each EEG; the ground-truth reference standard is established by a majority opinion of the expert reviewers
This data collection method resulted in a dataset of 350 subjects representative of the intended patient population. The demographic distribution of the subjects is shown in the following tables.

Subject Age (years)	IncludedSubjects	ExcludedSubjects	Percent of TotalIncluded Subjects
< 18	0	3	N/A
18-20	4	0	1%
21-30	14	0	4%
31-40	23	0	7%
41-50	40	0	11%
51-60	39	0	11%
61-70	79	0	23%
71-80	63	0	18%
81-90	73	0	21%
>90	15	0	4%
Total:	350	3
Mean Age of IncludedSubjects:	65.3

Table 3. Validation dataset age demographics showing included and excluded subjects.

Table 4. Distribution of patient gender in the validation dataset.

Subject Gender	N	Percent ofTotal
Male	188	54%
Female	162	46%
Total:	350

The expert neurologist review of the EEGs resulted in a reference-standard dataset that included 10 ESEpositive subjects out of the 350 total subjects. The ESE-negative cases were further subdivided into ESEnegative cases that contained seizure and/or other epileptiform activity versus ESE-negative cases that do not contain any epileptiform activity. This categorization of the ESE-negative cases is only for data analysis and benefit-risk analysis purposes. The output of the subject device is only ESE-positive or ESEnegative.

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Ground-Truth Classification	N
ESE-positive	10
ESE-negative: contains seizures and/orother epileptiform activity	94
ESE-negative: does not contain anyepileptiform activity	246
Total:	350

Table 5. Expert neurologist reference standard categorization of the validation dataset.

After the clinical validation dataset was compiled, the subject device algorithm was run on the dataset and the results compared to the reference-standard. The resulting sensitivity was 100% and the specificity was 94%. There were 10 true-positive detections and 0 false-negative detections (100% sensitivity). There were 319 true-negative detections and 21 false-positive detections (94% specificity). Of the 21 falsepositive detections, 19 were determined by the expert reviewers to contain seizures or other epileptiform activity.

Because the algorithm performed with 100% sensitivity in a small sample size of 10 ESE true-positive detections, there are limitations to the utility of calculating 95% confidence interval using the BCa Bootstrap method (as was done with the predicate device). As a result, two additional confidence interval calculation methods were also applied: the Wilson interval and the Jeffreys interval.

Table 6. Sensitivity and specificity results of the clinical performance validation along with the 95% confidence interval computed with three different methodologies.

	Result	95% ConfidenceIntervalBCa Bootstrap	95% ConfidenceIntervalWilson	95% ConfidenceIntervalJeffreys
Sensitivity	100%	[100%, 100%]	[72%, 100%]	[78%, 100%]
Specificity	94%	[91%, 96%]	[91%, 96%]	[91%, 96%]

Benefit Risk Analysis

Analysis of the benefits and risks of the subject device is performed according to the FDA guidance document "Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics." (September 2018). Ceribell believes that the submitted performance validation data clearly demonstrates significant benefit of the subject device due to the magnitude and the probability of the benefit of faster diagnosis of ESE. At the same time, the identified risks of the subject device are of low probability and low severity, post-mitigation.

The greatest benefits of the subject device are specifically tied to the intended use of diagnosing electrographic status epilepticus. The maximum benefit of the subject device occurs when ESE is recognized and diagnosed during the time prior to the availability of a qualified neurologist to perform a

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full review of the underlying EEG. Initiation of treatment for Status Epilepticus is highly time sensitive, yet in the standard-of-care workflow it can take 12-24 hours just to get the EEG read by a qualified neurologist. The diagnosis of ESE provided by the subject device allows administration of first-line antiseizure medications (ASMs) and initiation of other time-sensitive actions to be performed as quickly and as accurately as possible by the intensivist and other members of the bedside critical care team. At the same time, the subject device does not replace the full review of the underlying EEG by a qualified neurologist because pathologies other than ESE may be present in the EEG.

Risks of the subject device can be categorized into risks associated with false-positive detections, falsenegative detections, device malfunctions, or device misuse. In general, these risks are all low in part due to the fact that in all potential cases of failure of the subject device, the patient remains no worse off compared to the current standard-of-care, where the intensive care physician is forced to make a treatment decision without having EEG data available.

Table 7 and Table 8 on the following pages provide a detailed analysis of the benefits and risks of the subject device.

Conclusion:

The performance demonstrated in the clinical validation study clearly demonstrate that the benefits of the subject device outweigh the risks.

The Ceribell Status Epilepticus Monitor has the same intended use as the predicate devices. In addition, it has similar technological characteristics and performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness. Therefore, the Ceribell Status Epilepticus Monitor is substantially equivalent to the cleared predicate device.

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Table 7. Benefits analysis of the subject device.

Benefits	Magnitude of Benefit	Probability of Benefit	Overall BenefitEvaluation
Patient with ESE is treated withASMs 12-24 hours fastercompared to the currentstandard-of-care when thesubject device correctlyidentifies that ESE is present.	HighAs discussed above, earlyidentification and treatment of ESE isassociated with significantly lowermorbidity and mortality.	HighThe subject device was 100%sensitive to ESE in the performancevalidation study.	High
Patient without ESE avoidsunnecessary treatment withASMs when the subject devicecorrectly determines that ESE isnot present.	LowRuling out ESE may avoidunnecessary patient treatment.However, this benefit is "low"because the use of ASMs in hospitalenvironments is commonplace andcarries relatively low risk because ofthe clinicians' familiarity withmanagement of these medications.	HighThe performance validation studyshowed that the subject device had94% specificity.	Low

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Table 8. Risks analysis of the subject device.

Risk	Severity	Mitigations	Risk Probability (post-mitigation)	Overall RiskEvaluation
False-positive:Subject devicediagnoses ESE whenESE is not present.Patient is treated withASMs even thoughthey are not in statusepilepticus	ModerateThe use of ASMs incontrolled hospitalenvironments (with orwithout confirmation ofseizures through EEG) iscommonplace andcarries relatively low riskbecause of the clinicians'familiarity withmanagement of thesemedications. As with anysedative medication,there is risk of over-sedation.	• The subject device is designed suchthat the majority of "false-positive"cases still contain seizures or otherabnormal epileptiform patterns. Inthese cases, treatment with ASMsmay still be beneficial to thepatient.• Full review of the EEG by a qualifiedneurologist (potentially 12-24 hourslater) may determine that ASMtreatment can be discontinued.	LowThe performance validation study resultsshowed there were 21 "false positives"out of 350 cases (6%) and 19 of the 21"false-positive" cases (90.5%) stillcontained seizures or other epileptiformpatterns where treatment with ASMsmay still have been beneficial.	Low
False-negative:Subject device fails todiagnose ESE whenESE is presentTreatment with ASMsis delayed.	HighDelayed treatment ofstatus epilepticus resultsin worse outcomes.However, this scenario isequivalent to thecurrent standard-of-care.	• The subject device is designed to behighly sensitive to minimize the riskof "false-negative" cases.• The intensivist may still elect totreat the patient with ASMs basedon other clinical observations; theEEG will still be reviewed by aqualified neurologist - the patient isno worse off than they would havebeen in the current standard-ofcare without the subject device.	LowThe performance validation studyshowed that the subject device was100% sensitive to ESE.	Low
Risk	Severity	Mitigations	Risk Probability (post-mitigation)	Overall RiskEvaluation
Device malfunction:Subject device fails toprovide output.	LowThe user can revert tothe current standard-of-care practice	• The subject device alerts the user ifthe ESE detected/not-detectedoutput is not available. The user canrevert to the current standard-of-care without the subject deviceoutput.	LowVerification and validation testingconfirm that the subject device meets itsdesign requirements.	Low
Device misuse:User incorrectlyutilizes the output ofthe subject device(i.e., uses the deviceoutput to makeclinical determinationsoutside of thediagnosis of ESE).	ModerateDepending on thepatient's condition, thismay involve over-treatment or delayed-treatment with ASMs.	• The subject device is only capableof providing a binary diagnosticoutput of ESE detected/ESE not-detected. A qualified neurologistmust review the EEG for otherpossible abnormal epileptiformfindings – this limits the potentialfor device misuse.• The use of ASMs in controlledhospital environments (with orwithout confirmation of seizuresthrough EEG) is commonplace andcarries relatively low risk because ofthe clinicians' familiarity withmanagement of these medications.As with any sedative medication,there is risk of over-sedation.	Low	Low

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Regulation Number and Section

§ 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).