(217 days)
The EarlySense InSight System is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight
A traditional 510(k) is submitted to clear the new EarlySense InSight System. The EarlySense Insight System developed by EarlySense Ltd. is designed for continuous and contact-free measurement of Heart and Respiratory Rate. In addition, the System tracks body motion; monitors patient movement and can notify users when the patient exits the bed or the chair. The device does not have a display and is controlled from a remote control and display station by the user. The measured data on Heart Rate, Respiratory Rate, Movement and alerts are communicated to a remote station that can communicate with the EarlySense device according to predefined protocol, to be displayed to users. The Remote Control and Display Device (RCD) can be computer or central monitoring device that can communicate with the InSight Unit through predefined standard protocol through LAN or Wi-Fi and is capable to remotely access the InSight Unit and display the information received from InSight Unit. All the settings and changing of configurations is performed by the user, via a Remote Control and Display Device (RCD device). The EarlySense Insight monitoring device can notify the Remote Control and Display device, when monitored parameters excurse above or below predefined limits. The user (Healthcare practitioner) receives the information and should actively acknowledge the alert notifications and adjust monitoring parameters as required.
The EarlySense InSight device incorporates the following components:
Acceptance Criteria and Study for EarlySense InSight System
This response is based solely on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in a quantitative or pass/fail format. However, it describes that the device's performance was compared to a reference device and found to be "similar."
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Heart Rate | Similar to reference device | Found to be similar |
| Respiration Rate | Similar to reference device | Found to be similar |
| Motion Measures | Similar to reference device | Found to be similar |
| Communication | As good as predicate device | Found to be as good as EarlySense 2.0 |
2. Sample Size Used for the Test Set and Data Provenance
The document states that signals were tested from "children, adolescents and adults' populations," suggesting a diverse age range. However, it does not specify the exact sample size (number of individuals or data points) for the test set.
Data Provenance: The document does not explicitly state the country of origin. It describes "Non Clinical Testing" and refers to "signals from children, adolescents and adults' populations were tested." Given that the submitter is EarlySense Ltd. from Israel, it's possible the data originated there, but this is not confirmed. The study appears to be prospective benchmark testing given its description of "side by side performance testing" against a reference device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications to establish ground truth.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. The ground truth was established by a "reference device" rather than human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study described focuses on the standalone performance of the EarlySense InSight device against a reference device and its predicate, rather than comparing human reader performance with and without AI assistance.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The "Non Clinical Testing" section explicitly describes "side by side performance testing of the InSight device vs. its predicate EarlySense 2.0. Signals from children, adolescents and adults' populations were tested. The accuracy of the InSight and EarlySense 2.0 in analyzing the signals and generating heart rate, respiration rate and motion measures were compared to results of reference device (Embla Sleep lab. System Medcare K024322)." This directly assesses the algorithm's performance without human intervention.
7. The Type of Ground Truth Used
The ground truth used was based on a reference device: "Embla Sleep lab. System Medcare K024322." This is a medical device indicated for sleep laboratory use, implying a high standard for physiological measurements.
8. The Sample Size for the Training Set
The document does not specify the sample size used for the training set. It only mentions that the system's detection algorithms are "the same as those used in the predicate EarlySense 2.0 device" and that the predicate device likely used data for its development.
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly describe how the ground truth for the training set was established. It states that the algorithms are the same as those from the predicate EarlySense 2.0 device, which implies that the training was done for the predicate device, but the details of that process (e.g., specific ground truth methods or datasets) are not provided in this submission.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).