The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults in home or healthcare facilities during periods of rest. The device is worn on the wrist, and senses Electrodermal Activity (EDA) and motion data to detect patterns that may be associated with generalized tonic seizures in patients with epilepsy or at risk of having epilepsy. When a seizure event is detected, Embrace sends a command to a paired wireless device that is programmed to initiate an alert to a designated caregiver. The System records and stores data from Accelerometers, EDA, and Temperature for subsequent review by a trained healthcare professional.

Device Description

The Embrace is a wearable biosensor device that can capture, store, and wirelessly transmit sensor data via Bluetooth to a paired remote device. Embrace runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTC). The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCs in hospital Epilepsy Monitoring Units. When a likely GTC is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers.

AI/ML Overview

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

1. A table of acceptance criteria and the reported device performance

Metric	Acceptance Criteria (Implied)	Reported Device Performance
Positive Percent Agreement (PPA)	Not explicitly stated but inferred to be clinically acceptable and comparable to prior devices, ensuring effective detection of GTC seizures. Given the reported value, it's expected to be high.	1.0 (corrected PPA = 0.9334) with a 95% CI of [0.9213, 0.9424]
False Alarm Rate (FAR)	Not explicitly stated but inferred to be clinically acceptable and comparable to prior devices, ensuring a manageable number of false alerts for caregivers. Given the reported value, it's expected to be low.	0.4286 false alarms per 24 hours with a 95% CI of [0.3425, 0.7002], corresponding to a mean FAR of 0.5894

Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for PPA and FAR. Instead, it reports the device's performance metrics and implicitly suggests that these values are deemed acceptable for marketing the device as "substantially equivalent" to a predicate device. The FDA typically relies on a comparison to predicate devices and clinical justification for novel devices.

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

Sample Size for Test Set:
- 135 patients diagnosed with epilepsy were enrolled.
- Out of these, 22 patients experienced a total of 40 generalized tonic clonic seizures (GTCSs).
- 113 patients did not experience any seizures during the study.
Data Provenance:
- Country of Origin: Not explicitly stated, but the study was conducted within an "Epilepsy Monitoring Unit (EMU)" in a "top level 4 epilepsy center," suggesting a clinical setting in a developed healthcare system (likely the US, given the FDA submission).
- Retrospective or Prospective: The study enrolled patients and observed them for seizure events within the EMU, implying a prospective collection of data for the purpose of validating the device.

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

Number of Experts: Three readers.
Qualifications of Experts: They are referred to as a "panel of three readers." Although their specific qualifications (e.g., neurologists, epileptologists, years of experience) are not explicitly detailed in this document, the context of an "Epilepsy Monitoring Unit" and "gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists" strongly suggests they were highly qualified medical professionals specializing in epilepsy and EEG interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document mentions "relative to a panel of three readers" for PPA calculation. This implies that the ground truth was established by consensus (or agreement) among these three readers. The specific adjudication method (e.g., if at least 2 out of 3 had to agree, or if all 3 had to agree, or if a tie-breaking fourth expert was used) is not explicitly stated. However, the use of a "panel" suggests a structured review process.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Was an MRMC comparative effectiveness study done? No. The study described focuses on the standalone performance of the Embrace device (i.e., the algorithm's ability to detect seizures) against a human-established ground truth. It does not evaluate how human readers' performance might change with or without the device's assistance.

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

Yes, a standalone performance study was done. The performance metrics (PPA and FAR) directly reflect the algorithm's ability to detect GTC seizures based on sensor data. The device "runs an on-board algorithm to continuously process sensor data and make a decision about whether the data might indicate a generalized tonic clonic seizure (GTC)."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth Type: Expert consensus based on "gold-standard video-Electroencephalogram (EEG) methodology." This is a strong form of ground truth for epilepsy, as video-EEG is the primary method for diagnosing and classifying seizures in clinical practice. The data was "labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists."

8. The sample size for the training set

The document states, "The algorithm has been validated on data, labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center, from epilepsy patients experiencing GTCs in hospital Epilepsy Monitoring Units."

However, it does not explicitly state the sample size of the training set. It only describes the validation set (the 135 patients). It's common for regulatory submissions to omit detailed training set information, focusing instead on the independent validation (test) set.

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

The ground truth for the training set (implied, as the exact set is not detailed) was established using the "gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 4 epilepsy center." This indicates that the training data was meticulously labeled by highly qualified experts using the most reliable method for seizure detection.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 26, 2018

Empatica Srl % Rakesh Lal Consultant 318 Rindge Ave 407 Cambridge, Massachusetts 02140

Re: K172935

Trade/Device Name: Embrace Regulation Number: 21 CFR 882.1580 Regulation Name: Non-EEG Physiological Signal Based Seizure Monitoring System Regulatory Class: Class II Product Code: POS Dated: December 27, 2017 Received: December 27, 2017

Dear Mr. Lal,

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Hoffmann -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Druq Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K172935

Device Name Embrace

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

Submitter Name:	Empatica, Srl
Submitter Address:	Via Stendhal 3620144 Milano, Italy
510(k) Submission Contact:	Rakesh Lal817-734-8303
Sponsor Contact Person:	Matteo Lai,+393497888125
Date Prepared:	September 22, 2017
Device Trade Name:Device Common Name:Device Classification:	EmbraceNon-EEG physiological signal based seizure monitoring system21 CFR 882.1580, Product Code POS
Predicate Device:Predicate Device Classification:	Companion, DEN14003321 CFR 882.1580, Product Code POS
Device Description:	The Embrace is a wearable biosensor device that can capture, store, andwirelessly transmit sensor data via Bluetooth to a paired remote device.Embrace runs an on-board algorithm to continuously process sensor data andmake a decision about whether the data might indicate a generalized tonicclonic seizure (GTC). The algorithm has been validated on data, labeled usingthe gold-standard video-Electroencephalogram (EEG) methodology designed bya group of epileptologists at a top level 4 epilepsy center, from epilepsy patientsexperiencing GTCs in hospital Epilepsy Monitoring Units. When a likely GTC isdetected, the Embrace sends a message to the Alert smartphone application,which initiates calls and texts to summon the attention of designatedcaregivers.
Indications for Use:	The Embrace is a prescription only device that is indicated for use as an adjunctto seizure monitoring of adults in home or healthcare facilities during periods ofrest. The device is worn on the wrist, and senses Electrodermal Activity (EDA)and motion data to detect patterns that may be associated with generalizedtonic clonic seizures in patients with epilepsy or at risk of having epilepsy. Whena seizure event is detected, Embrace sends a command to a paired wirelessdevice that is programmed to initiate an alert to a designated caregiver. TheSystem records and stores data from Accelerometers, EDA, and Temperaturefor subsequent review by a trained healthcare professional

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Substantial Equivalence:

A comparison of Embrace to the predicate device is provided in the table below.

Attribute	Embrace	Brain SentinelMonitoring and AlertingSystem	Comparison
Intended Use	Non-EEG physiologicalsignal based seizuremonitoring system.	Non-EEG physiologicalsignal based seizuremonitoring system.	EQUIVALENTBoth devices have thesame intended use.
Indications for use	The Embrace is aprescription only devicethat is indicated for useas an adjunct to seizuremonitoring of adults inhome or healthcarefacilities during periodsof rest. The device isworn on the wrist, andsenses ElectrodermalActivity (EDA) andmotion data to detectpatterns that may beassociated withgeneralized tonic clonicseizures in patients withepilepsy or at risk ofhaving epilepsy. When aseizure event isdetected, Embracesends a command to apaired wireless devicethat is programmed toinitiate an alert to adesignated caregiver.The System records andstores datafrom Accelerometers,EDA, and Temperaturefor subsequent review bya trained healthcareprofessional.	The Brain SentinelMonitoring and AlertingSystem is indicated foruse as an adjunct toseizure monitoring ofadults in the home orhealthcare facilitiesduring periods of rest.The device is to be usedon the bicep muscle'sbelly to analyze surfaceelectromyographs (sEMG)signals that may beassociated withgeneralized tonic-clonic(GTC) seizures and togenerate an alarm toalert caregivers ofunilateral, appendicular,tonic extension that couldbe associated with a GTCseizure. The Systemrecords and stores sEMGdata for subsequentreview by a trainedhealthcare professional.	Patient Population:EQUIVALENTBoth devices areindicated for use onadults.Healthcare Environment:EQUIVALENTBoth the subject andpredicate devices areindicated for use in thehome and healthcaresettings.Seizure Type:EQUIVALENTBoth devices areindicated to provide analert to caregivers whenthey each detect GTC.The predicate deviceprovides alerts ofunilateral, appendicularor tonic extensions thatmay be associated with aGTC seizure, while thesubject device generatesalerts of patterns inelectrodermal andmovement signals thatmay be associated withgeneralized tonic clonicseizures. Both devicesmonitor physiologicalsignals while the patientis at restEffect on ClinicalOutcome: EQUIVALENTBoth devices are
Sensor Technology	Utilizes an electrodermalsensor to acquireElectrodermal Activity,and an accelerometersensor to acquiremovement data.	Utilizes a surface EMGsensor to acquire sEMGdata.	indicated as an adjunct toother monitoring devicesin the EMU. Neither ofthe devices is intended toguide therapy decisions.EQUIVALENTThe difference in type ofsensor does not raisedifferent questions ofsafety and effectiveness.EDA sensors andaccelerometer sensorsare commonly used inmany kinds of consumerand healthcaretechnology and aregenerally safe.EQUIVALENT
Software Level ofConcern	Moderate	Moderate	EQUIVALENT
Data Communication	The Embrace devicecommunicates wirelesslyto a smartphoneapplication, which alertsthe healthcare provideror caregiver in one ormore ways (phone call,text message, etc.).	The sEMG monitorcommunicates wirelesslyto the base station, whichalerts a healthcareprovider or caregiver inone or more ways (e.g.,audible alarm, textmessage, e-mail, etc.).	EQUIVALENTBoth systems utilizewireless communicationbetween the sensor and abase station or app, andtechnologies such as textmessaging to alert thecaregiver.
Algorithm	Uses algorithms toanalyze EDA andaccelerometer data todetect patterns in thedata that may beassociated withgeneralized tonic clonicseizures	Uses algorithms toanalyze sEMG data todetect unilateral,appendicular, tonicextension that could beassociated with a GTCseizure	EQUIVALENTThe difference in thealgorithms do not raisedifferent questions ofsafety and effectiveness.The same questions ofsafety and effectivenessregarding performance ofthe algorithms (PPA andFAR) apply to bothdevices.
Biocompatibility	All patient contactingparts are tested toapplicable tests in ISO10993 (Cytotoxicity - ISO10993-5, Sensitization -ISO 10993-10, and SkinIrritation - ISO 10993-10).	All patient contactingparts are tested toapplicable tests in ISO10993 (Cytotoxicity - ISO10993-5, Sensitization -ISO 10993-10, and SkinIrritation - ISO 10993-10).	EQUIVALENTBoth devices have patientcontacting parts thatcome into contact withintact skin for a durationthat may exceed 24hours. Both devices meetthe requirements of ISO10993.
Electrical Safety	Electrical Safety testing		EQUIVALENT
	performed to IEC 60601-1Electromagneticcompatibility testingperformed to IEC 60601-1-2 4th Edition
Thermal Safety	Not applicable. Thedevice does not generateany localized heat	Not applicable. Thedevice does not generateany localized heat	EQUIVALENT
Chemical Safety	Not applicable. Patient isnot exposed to anychemicals during use ofthe device	Not applicable. Patient isnot exposed to anychemicals during use ofthe device	EQUIVALENT
Radiation Safety	Not applicable. Devicedoes not use any ionizingradiation	Not applicable. Devicedoes not use any ionizingradiation	EQUIVALENT

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Performance Testing:

Performance testing demonstrates that Embrace complies with IEC 60601-1:2005+AMD1:2012, IEC 60601-1-2:2014, ISO 10993-5:2009, and ISO 10993-10:2010

Clinical Testing:

Clinical testing was performed to demonstrate the ability of the Embrace to function as an assessment aid for monitoring for seizure related activity in the intended population and for the intended use setting.

Patients:

135 patients diagnosed with epilepsy were admitted to the Epilepsy Monitoring Unit (EMU) for standard care were enrolled in the studies: 76 children (39 males), ages 5 months -17 years, median: 10.5 years; 59 adults (23 males), ages: 18-63 years, median: 37 years.

Observed GTCS:

22 EMU patients experienced a total of 40 generalized tonic clonic seizures (GTCSs) while 113 EMU patients didn't experience any seizure. The 40 recorded GTCSs included 10 primarily generalized tonic-clonic seizures and 30 secondarily generalized tonic-clonic seizures. Every recorded seizure was classified as epileptic. Seizures other than GTCSs were discarded from the analysis.

Recorded data:

135 patients provided overall 272.1 days (6,530.0 hours), with a median of 34.5 hours of data per patient (min-max range = 3 - 386.8 hours) of ACM and EDA measurements.

Performance:

Positive percent agreement (PPA) was found to be 1.0 (corrected PPA=0.9334), with a 95% confidence interval of [0.9213, 0.9424], relative to a panel of three readers, and false alarm rate (FAR) was found to be 0.4286 false alarms per 24 hours with a 95% confidence interval of [0.3425, 0.7002], corresponding to a mean FAR (average of FARs across patients) of 0.5894.

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Conclusion:

The subject device has the same intended use as the predicate device, and differences in technological characteristics do not raise different questions of safety and effectiveness. On this basis, Embrace is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 882.1580 Non-electroencephalogram (EEG) physiological signal based seizure monitoring system.

(a)
Identification. A non-electroencephalogram (non-EEG) physiological signal based seizure monitoring system is a noninvasive prescription device that collects physiological signals other than EEG to identify physiological signals that may be associated with a seizure.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical parameters of the device, hardware and software, must be fully characterized and include the following information:
(i) Hardware specifications must be provided. Appropriate verification, validation, and hazard analysis must be performed.
(ii) Software, including any proprietary algorithm(s) used by the device to achieve its intended use, must be described in detail in the Software Requirements Specification (SRS) and Software Design Specification (SDS). Appropriate software verification, validation, and hazard analysis must be performed.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) The device must be designed and tested for electrical, thermal, and mechanical safety and electromagnetic compatibility (EMC).
(4) Clinical performance testing must demonstrate the ability of the device to function as an assessment aid for monitoring for seizure-related activity in the intended population and for the intended use setting. Performance measurements must include positive percent agreement and false alarm rate.
(5) Training must be provided for intended users that includes information regarding the proper use of the device and factors that may affect the collection of the physiologic data.
(6) The labeling must include health care professional labeling and patient-caregiver labeling. The health care professional and the patient-caregiver labeling must include the following information:
(i) A detailed summary of the clinical performance testing, including any adverse events and complications.
(ii) Any instructions technicians and clinicians should convey to patients and caregivers regarding the proper use of the device and factors that may affect the collection of the physiologic data.
(iii) Instructions to technicians and clinicians regarding how to set the device threshold to achieve the intended performance of the device.