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The Embrace is a prescription only device that is indicated for use as an adjunct to seizure monitoring of adults and children age 6 and up 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 clonic 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 Accelerometer, EDA, and Temperature sensors for subsequent review by a trained healthcare professional.

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 (GTCS). 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 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units. When a likely GTCS is detected, the Embrace sends a message to the Alert smartphone application, which initiates calls and texts to summon the attention of designated caregivers. The device also enables patients to manually record seizure events, and provides contextual information related to activity and sleep.

The provided document describes the FDA 510(k) clearance for the Empatica Embrace device, a non-EEG physiological signal-based seizure monitoring system. The information below is extracted and organized to answer your request.

1. Table of Acceptance Criteria and Reported Device Performance

While the document doesn't explicitly state "acceptance criteria" in a separate section with specific numerical thresholds for clearance, the performance results presented indicate the observed efficacy. The implicit acceptance criteria would be for the device to perform well enough to demonstrate substantial equivalence to the predicate device and ensure safety and effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 141 patients diagnosed with epilepsy.
  • 80 pediatric patients (ages 6-21 years, median: 13 years)
  • 61 adult patients (ages 22-63 years, median: 39 years)
• Data Provenance: The study was conducted in a hospital Epilepsy Monitoring Unit (EMU) setting. While the document doesn't explicitly state the country of origin, the listed submitter address is in Milan, Italy. The data is prospective as patients were enrolled and monitored during their EMU stay for the purpose of this study.
• Observed GTCS: 31 EMU patients experienced a total of 54 generalized tonic-clonic seizures (GTCSs). 110 EMU patients did not experience any seizure.
• Recorded Data: 141 patients provided overall 409 days (9,806 hours) of ACM (accelerometer) and EDA (electrodermal activity) measurements, with a median of 49.2 hours of data per patient.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: A "panel of three readers" was used.
• Qualifications of Experts: The ground truth was established using "the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers." This implies the "readers" were highly qualified medical professionals experienced in epilepsy diagnosis and seizure classification, likely epileptologists, given the standard of care in EMUs. Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

The document states "relative to a panel of three readers." While it doesn't explicitly detail the adjudication method (e.g., majority vote, independent assessment with reconciliation), the phrase "panel of three readers" suggests a consensus or majority agreement approach was used to establish the ground truth from the video-EEG data. It is not explicitly stated as 2+1 or 3+1, but rather that the ground truth was derived from the consensus of these three readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No MRMC comparative effectiveness study was described where human readers' performance with and without AI assistance was evaluated. This study focused on the standalone performance of the device's algorithm in detecting GTCS.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, a standalone performance study was done. The reported PPA and FAR metrics represent the performance of the Embrace device's algorithm in detecting GTCS events based on its internal processing of EDA and motion data, without direct human intervention in the detection process. The device sends an alert when a likely GTCS is detected, which then initiates actions by caregivers. The study evaluates the accuracy of these automated detections.

7. The Type of Ground Truth Used

• The ground truth used was expert consensus based on gold-standard video-Electroencephalogram (EEG) methodology. This is considered a high-fidelity ground truth for seizure detection in an Epilepsy Monitoring Unit (EMU) setting. Every recorded seizure was classified as epileptic.

8. The Sample Size for the Training Set

The document states: "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 (GTCS). 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 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units."

• The document describes the validation of the algorithm on data from specific sources but does not explicitly state the sample size used for the training set. The 141 patient dataset is specifically described as the "clinical testing" dataset, suggesting it was used for evaluation, not necessarily for training. It's common for validation data to be distinct from training data.

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

• Similar to the validation set, the description implies that the data used for training (or at least development and refinement) of the algorithm was "labeled using the gold-standard video-Electroencephalogram (EEG) methodology designed by a group of epileptologists at a top level 6 epilepsy centers, from epilepsy patients experiencing GTCSs in hospital Epilepsy Monitoring Units." This indicates a high-quality, expert-driven ground truth establishment process for the data used to develop and refine the algorithm.

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