(210 days)
The EverOn (modified EarlySense™ ES-16) system is intended for continuous measurement of respiration rate and heart rate, in an automatic contact-less manner, at home, hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EverOn has been studied in children (weight ≥10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
The modified EarlySense™ EverOn System is designed for continuous and contact-less monitoring of respiration and heart rates. The system automatically starts measuring whenever the patient is in bed under resting or sleeping conditions. The EverOn enables the user to define upper and lower thresholds so an alert notification (audible and visible) is given to the user, if either heart rate or respiration rate exceed the thresholds set by the user. The EverOn also detects patient movement levels and provides patient out-of-bed (Bed Exit) notification to the user. The EverOn System consists of the following main components: - A Sensing Unit placed under the mattress or mattress pad. - A Control Unit (Bedside Unit). - Proprietary recording and data analysis software The under mattress Sensing Unit includes a piezoelectric sensor, which converts mechanical movements into an electric signal. The Control Unit receives the electric signals, processes them and finally calculates, logs, displays the patient's parameters, and generates alerts as per set thresholds. when needed.
Here's a breakdown of the acceptance criteria and study information for the EverOn System, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The provided text only explicitly states the intended use and performance characteristics the device aims to achieve, primarily related to continuous, contact-less monitoring of respiration and heart rates, and bed exit notification. However, it does not provide specific numerical acceptance criteria (e.g., accuracy percentages, thresholds for error) or detailed reported device performance metrics in a quantifiable format within this 510(k) summary.
The document states:
- "Performance testing demonstrating the accuracy of the system (bench and clinical data)" was performed.
- The EverOn System is "substantially equivalent in all aspects... performance characteristics (accuracy)" to the predicate device.
To fully answer this, we would typically need a more detailed performance study report, which is usually part of the 510(k) submission but not fully contained in this summary.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document states that the operation of the EverOn has been "studied in children (weight ≥10 Kg) and adults (weight ≤111 Kg)". However, it does not specify the exact number of subjects or the sample size used for the performance testing.
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It generally refers to "clinical data." It also does not explicitly state whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the given text.
4. Adjudication Method for the Test Set
This information is not provided in the given text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
- Was an MRMC study done? No, the EverOn system is a continuous physiological monitor (measuring respiration and heart rate, and bed exit), not an imaging or diagnostic device typically evaluated with MRMC studies comparing human readers with and without AI assistance. Therefore, a comparative effectiveness study of this nature is not applicable and was not conducted/reported here.
- Effect size of human improvement with AI vs without AI: N/A, as an MRMC study was not performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Done
Yes, the document implies standalone performance testing was done. The device is designed for "continuous and contact-less monitoring" and "automatically starts measuring," generating alerts based on pre-defined thresholds. The "Performance testing demonstrating the accuracy of the system (bench and clinical data)" would inherently evaluate the algorithm's ability to measure these parameters and detect events without human intervention during the measurement phase. The user sets thresholds, but the system automatically detects and alerts.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. For respiration rate and heart rate monitoring devices, common ground truths include:
- Simultaneous monitoring with a reference clinical device (e.g., ECG for heart rate, capnography or impedance pneumography for respiration rate).
- Manual counting by trained clinicians.
- Bench testing with controlled physiological signals.
The text only generally refers to "Performance testing demonstrating the accuracy of the system (bench and clinical data)."
8. Sample Size for the Training Set
This information is not provided in the given text. The 510(k) summary focuses on validation, not the development or training of the underlying algorithms, which might have occurred earlier.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the given text, as information about the training set itself is absent.
§ 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).