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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 <111 Kg) during sleep and resting condition. In addition, EarlySense (EverOn) System can continuously monitor oxygen saturation of arterial hemoglobin (SPO2) using pulse oximetry in pediatric (ages 2 years and older), adolescents, and adults at home, hospital, or clinical settings.

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 <111 Kg) during sleep and resting condition," but it doesn't specify if this refers to the current submission's testing or the predicate's testing. Given the focus on the oximetry module addition, it's possible the bench testing involved simulated data or controlled physiological models.

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 summary. For "bench testing" of oximetry, the ground truth would typically come from a reference oximeter or blood gas analysis, not expert interpretation. For the existing functions (respiration rate, heart rate, movement), as it is claimed to be "identical to the cleared EverOn 1.0," the ground truth establishment would refer to the original K092062 submission.

4. Adjudication Method for the Test Set

This information is not provided as the summary focuses on technical compliance and bench testing rather than clinical study data requiring expert adjudication.

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

There is no indication that an MRMC comparative effectiveness study was performed or that AI assistance for human readers is part of this device's functionality. The EarlySense system is a monitoring device that provides objective measurements, not an AI diagnostic aid for human interpretation.

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

Yes, the testing described appears to be standalone performance evaluation of the device's algorithms and hardware. The "bench testing" and "software verification and validation testing" assess the device's ability to accurately measure and display parameters independently. The device's intended use is for continuous, automatic contact-less measurement, implying a standalone function.

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

For the oximetry part, the ground truth would typically be established against a clinical reference oximeter or arterial blood gas analysis. For the respiration rate, heart rate, and movement components, given their "identical" nature to the predicate, the ground truth for their original clearance (K092062) would have likely involved reference physiological monitoring equipment (e.g., ECG for heart rate, capnography or specialized respiratory sensors for respiration rate, accelerometers or pressure sensors for movement). The summary indicates "bench testing" which suggests controlled environments where reference measurements are used.

8. The sample size for the training set

This information is not provided. The summary does not disclose details about machine learning or AI model training data. It focuses on the device's functional performance and equivalence.

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

This information is not provided, as details about training sets or the specific algorithms for the core measurements are not disclosed in this summary.

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