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The EarlySense (EverOn) System is intended for continuous measurement of respiration rate, heart rate and movement, 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 EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight

The EarlySense (EverOn) System consists of the following main components:

• A piezoelectric Sensing Unit placed under the mattress or mattress pad.
• Bedside Unit with Proprietary recording and data analysis software
• OEM Oximetry Module (optional)
  The EarlySense (EverOn) System is designed for continuous and contact-less monitoring of respiration rate, heart rate and movement. The under mattress Sensing Unit includes a piezoelectric sensor, which converts mechanical movements into an electric signal. The principles and the mode of operation for the capability of contactless monitoring of the EarlySense (EverOn) is identical to the cleared EverOn 1.0 (K092062). The EarlySense interfaces with a pulse oximeter OEM module (optional feature) and can therefore also monitor oxygen saturation. The oximetry module is connected externally via UART (RS232/TTL) to the Bedside unit. A compatible oximetry sensor is then attached to the patient's finger and the monitor begins to continuously display oximetry data (e.g. SpO2).
  The Bedside Unit, processes inputted signals, displays the patient's parameters, and generates alerts (respiration rate, heart rate, movement, and SpO2) as per set thresholds when needed. The continuously accumulated data from the monitored period are displayed on the bedside unit and communicated, via wired or via wireless LAN communication to a dedicated may options of SerilySense Central Display Station (CDS) - cleared under K100376 and K110521). Analysis of the results may be performed either on-line during the monitoring session, or later, off-line. Data for each patient is recorded and can therefore also be retrieved and presented.

Here's a breakdown of the acceptance criteria and study information for the EarlySense (EverOn™) System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses primarily on showing substantial equivalence to predicate devices and adherence to general safety and performance standards. It does not explicitly state specific quantitative acceptance criteria for respiration rate, heart rate, movement, or SpO2, nor does it provide detailed performance values for these metrics. Instead, the summary emphasizes that a "set of software and bench testing was performed to demonstrate the performance and accuracy" and that the device "performs according to its specifications described in the Software Requirements Specifications (SRS)."

However, given the context of a 510(k) for an oximetry module addition and an existing cleared device, we can infer the type of performance that would be required for the added oximetry function based on typical regulatory expectations for pulse oximeters. For the existing functions (respiration rate, heart rate, movement), the claim is that its operation is "identical to the cleared EverOn 1.0 (K092062)."

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

The summary does not provide specific sample sizes for particular performance tests. It mentions "bench testing" and "software verification and validation testing." No information about human subject test sets (sample size, country of origin, retrospective/prospective) is provided beyond the existing claim of equivalence to the predicate device for respiration rate, heart rate, and movement. The indication for use states, "The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight

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The EverOn Central Display Station (CDS) is intended to provide secondary display of the information as displayed on multiple individual bed side monitoring units, on a central remote screen. The EverOn CDS is not intended to replace any part of the bed-side patient monitoring procedures. The system can be used in hospitals or hospital type and clinic environment.

The EverOn Central Display Station (CDS) is intended to communicate with multiple EverOn bed-side monitoring devices and remotely display the information as displayed on multiple individual bed side monitoring units, on a central screen. The communication can be performed either via standard wired or via wireless LAN communication.

The transmitted information from Bed-side to CDS includes alert information and physiological parameters. The CDS can also format the alert information as obtained from bed-side units into a message that can be transmitted to external devices that can communicated with the CDS via standard TCP/IP port. Data and report files (.CSV and .PDF) generated at the bed-side units can be retrieved via the CDS by the user and can be downloaded and / or sent for printing from the CDS. The CDS includes standard hardware (PC, communication and IT hardware). EarlySense develops the application software which is used on the system's PC computer (Central Display Station).

The provided document is a 510(k) summary for the EverOn Central Display Station (CDS) with wireless communication capability. This document focuses on demonstrating substantial equivalence to a predicate device and certifying compliance with relevant standards, rather than providing detailed performance data from a clinical study with acceptance criteria in the typical sense for a diagnostic algorithm.

Therefore, many of the requested points regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study types (MRMC, standalone) are not applicable or not explicitly detailed in this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of acceptance criteria and reported device performance in the manner typically seen for diagnostic algorithms. Instead, the "performance data" section focuses on demonstrating the safety and effectiveness of the modification (wireless communication) to an already cleared device and showing compliance with established standards.

The acceptance criteria are implicitly those of the standards met and the successful completion of verification and validation testing, hazard analysis, and full load bench testing.

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

• Test Set Sample Size: Not explicitly stated. The full load bench testing implies a robust simulation or real-world test, but the number of bed-side units or data points is not
  quantified.
• Data Provenance: Not applicable in the context of a clinical test set. The testing was conducted by EarlySense Ltd.

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

Not applicable. The performance evaluation was engineering-focused (software verification, bench testing, hazard analysis) rather than clinical. There's no mention of experts establishing clinical ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable. This testing did not involve human interpretation or adjudication in the context of clinical ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is not relevant for a device like the EverOn CDS, which is a display and communication system, not a diagnostic algorithm that assists human readers in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a display system, not a standalone diagnostic algorithm. The performance testing described (software verification, bench testing) could be considered "standalone" in the sense that it evaluates the system's function independently without continuous human interaction during the test, but it is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was defined by:

• Engineering specifications and requirements (for software verification and validation).
• Expected communication protocols and display accuracy (for bench testing).
• Industry standards for safety, risk management, and software development (EN/IEC 60601-1-4, ISO 14971-1, IEC 62304, IEC 60812).

8. The Sample Size for the Training Set

Not applicable. The EverOn CDS is a software-driven display and communication system, not an AI/Machine Learning algorithm that requires a training set.

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

Not applicable, as no training set was used.

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The EverOn 1.0 system is intended for continuous measurement of respiration rate, heart rate and movement, 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 EverOn 1.0 System is designed for continuous and contact-less monitoring of respiration rate, heart rate and movement. The system automatically starts measuring whenever the patient is in bed. The EverOn can provide alert notification (audible and visible) if either parameters exceed predefined thresholds set by the user. The EverOn can also provide patient out-of-bed (Bed Exit) alert 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 an analysis of the provided text regarding the acceptance criteria and study for the EarlySense EverOn 1.0 System:

Acceptance Criteria and Study for EarlySense EverOn 1.0 System

The documentation focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the system's ability to detect movement. The primary acceptance criteria provided relate to the accuracy of movement detection.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document doesn't explicitly state the 'acceptance criteria' in numerical thresholds (e.g., "accuracy must be >= 90%"). Instead, it presents the achieved accuracy values as evidence of meeting performance requirements and demonstrating equivalence.

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

The document does not explicitly state the numerical sample size (number of patients) used for the clinical testing in either the adult or children populations. It mentions that clinical testing "was performed among both children and adult populations" without providing specific numbers.

• Data Provenance: The document does not specify the country of origin for the clinical study data. It is implied to be part of the regulatory submission from EarlySense Ltd. (Israel). The study appears to be prospective as it describes the system's accuracy being "compared to two reference methods: Predicate and Gold Standard" during clinical testing.

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

The document does not provide information on the number of experts used or their qualifications to establish the ground truth. It simply refers to "Gold Standard" as one of the reference methods for comparison.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size regarding human reader improvement with or without AI assistance. The study focuses on the device's standalone performance in detecting movement against reference methods.

6. Standalone Performance Study

Yes, a standalone performance study was done. The reported accuracy percentages (e.g., "Overall Accuracy - Adults 95.6%") represent the performance of the EverOn 1.0 System (algorithm only, as it's a contact-less monitoring device) in detecting movement compared to the gold standard and a predicate device. This is a direct measurement of the algorithm's performance without human intervention in the interpretation process of the movement detection itself.

7. Type of Ground Truth Used

The types of ground truth used were:

• Gold Standard: The document refers to a "Gold Standard" without specifying its exact nature (e.g., expert observation, concurrent established medical device, video recording with manual annotation).
• Predicate Device (Compass): The Compass F10 system was used as a reference device, indicating its measurements were considered a form of ground truth for comparison.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set.

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

The document does not provide any information on how the ground truth for the training set (if any was used for algorithm development) was established. The submission focuses on the validation of the final device.

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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.

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