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The EarlySense 2.0 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 EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition. In addition, EarlySense 2.0 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.

Device Description

The modified EarlySense System 2.0 is similar to cleared (EverOn™1.0S) System (K120465) except for the hardware and software changes that are described below.

The cleared (K120465) EarlySense (EverOn™1.0S) System is comprised of the following components:

A Bed Sensing Unit based on piezoelectric sensing
A Bedside Unit incorporating a medical grade power supply and the following modules:

A Signal Sampling Module consisting of amplifiers, filters and analog to a. digital converter as well as a microprocessor designated to transfer the sampled data to the Signal Processing Module, and

b. A Signal Processing and Display Module.

An Optional Oximetry OEM module with communication interface and compatible marketed sensors.

AI/ML Overview

The EarlySense System 2.0 is a modified version of the EarlySense (EverOn™1.0S) System (K120465). The changes include modifications to the Bed Sensing Unit (adding an accelerometer, piezoelectric polymer sensor, and base plate handles) and the Bedside Unit (dimensional changes, replacement of power supply, speaker's buzzer, communication card, fan, additional USB and sensor's connectors, and software update to version 1.0.3).

Acceptance Criteria and Device Performance:

The provided 510(k) summary does not explicitly list numerical acceptance criteria or detail the specific performance metrics achieved by the EarlySense System 2.0. Instead, it states that the device was subject to various verification and validation tests and that the modifications "did not affect its performance, effectiveness or safety." The submission aimed to demonstrate substantial equivalence to the predicate device (K120465).

The performance claims rely on the device maintaining the same functionality and performance as its predicate, which was already cleared. The performance criteria for the predicate device would be relevant here, but are not provided in this document.

Studies and Ground Truth Information:

The document focuses on demonstrating that the modifications did not negatively impact the performance of the device and thus, it remains substantially equivalent to the cleared predicate. It does not present new clinical studies with detailed acceptance criteria and performance results in the same way a de novo submission might.

Here's an analysis of the provided information concerning studies:

#	Feature	Details Provided in K131379
1.	Acceptance Criteria & Reported Performance	Acceptance Criteria: Not explicitly stated as numerical targets for key performance metrics (e.g., accuracy, precision for HR/RR). The implicit acceptance criterion is that the modified device's performance is not worse than the predicate device. Reported Performance: The document states that "The results of the tests showed, that the modifications to the system did not affect its performance, effectiveness or safety." It does not provide specific performance values for respiration rate, heart rate, or movement.
2.	Sample Size & Data Provenance (Test Set)	Not specifically mentioned for a new clinical test set. The document refers to "Performance Bench Testing" (See Section 18 of the current submission), but details are not provided in this extract regarding sample size, country of origin, or retrospective/prospective nature. The intended use indicates studies were done with "children (weight ≥ 10 Kg) and adults (weight <111 Kg) during sleep and resting condition" for respiration rate, heart rate, and movement. For SpO2, it mentions "pediatric (ages 2 years and older), adolescents, and adults." This description refers to the scope of studies for the predicate device or a general statement of intended use, not necessarily a new test set for this 510(k) of a modified device.
3.	Number & Qualifications of Experts (Ground Truth)	Not mentioned in this summary. Ground truth establishment for the predicate device would have involved experts in cardiorespiratory monitoring.
4.	Adjudication Method (Test Set)	Not mentioned in this summary.
5.	MRMC Comparative Effectiveness Study	No. This 510(k) is for modifications to an existing device, focusing on substantial equivalence rather than comparative effectiveness with human readers.
6.	Standalone Performance Study (Algorithm Only)	Not explicitly detailed as a separate standalone study for the modified device. The document mentions "Performance Bench Testing." The EarlySense System is inherently a standalone algorithm reporting vital signs, so its primary clinical performance would be evaluated in a standalone manner against a reference standard. However, specific results from such a study for the modified device are not in this summary.
7.	Type of Ground Truth Used	Not explicitly stated in this summary for the "Performance Bench Testing." For vital sign monitors, ground truth typically comes from established medical devices (e.g., ECG, capnography, pulse oximeters) used as a reference standard.
8.	Sample Size for Training Set	Not mentioned in this summary. The device's algorithms were presumably developed and trained prior to the predicate device's clearance (K120465). This 510(k) is for modifications, and a new training set size is not discussed.
9.	Ground Truth for Training Set Establishment	Not mentioned in this summary. Ground truth for training would have been established using reference medical devices or expert interpretations of raw physiological signals.

Summary of Device Rationale for Substantial Equivalence:

The core of this 510(k) submission is to demonstrate that the modifications made to the EarlySense System 2.0 (hardware and software changes) do not significantly alter its fundamental principles of operation, intended use, indications for use, safety, or effectiveness compared to its previously cleared predicate device (EarlySense EverOn™ 1.0S, K120465). The submission primarily relies on verification and validation activities (risk analysis, software V&V, electrical safety, environmental testing, and performance bench testing) to show that the performance was not negatively affected by the changes. No new clinical study data with specific acceptance criteria and performance tables for the modified device are presented in this summary; rather, the argument is that the performance remains effectively the same as the predicate.

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