(196 days)
The EarlySense Chair Sensing Unit is intended to be used for continuous measurement of Respiration Rate, Heart Rate and Movement, in an automatic contact-less manner, at home, hospital or clinic setting. The sensor is indicated for use in children, adolescents and adults. The operation of the EarlySense system has been studied in children (weight ≥ 10 Kg) and adults (weight
EarlySense is submitting a new accessory for contactless measurement of heart, respiratory rate and motion, the Chair Sensing Unit. The Chair Sensing Unit, similar to its predicate, the EarlySense Bed Sensing Unit cleared as part of previous EarlySense system submissions (K070375, K082465, K092062, K120465), is intended for continuous measurement of Heart Rate, Respiration Rate and motion while the patient is resting.
The EarlySense Chair sensing unit is comprised of the following components:
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Sensor: that includes piezoelectric elements incorporated into a plate
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A cushion made of foam into which the sensor is inserted into - so not to be touched by the patient.
The Chair sensing unit should be connected to a bedside unit that receives and analyzes the signals from the Chair sensing unit to measure and display heart rate, respiratory rate and motion.
The EarlySense Chair Sensing Unit is an accessory to the EarlySense System for continuous, contactless measurement of Respiration Rate, Heart Rate, and Movement. The 510(k) summary provided does not contain specific, quantitative acceptance criteria or detailed results of a clinical study that proves the device meets such criteria. Instead, it relies on bench testing and comparison to a predicate device to establish substantial equivalence.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria or detailed performance data (e.g., accuracy, precision) for the EarlySense Chair Sensing Unit are explicitly stated in the document. The document primarily focuses on establishing substantial equivalence to the predicate device through bench testing rather than reporting precise performance metrics against pre-defined targets.
The general conclusion from bench testing is that: "the signals as detected by the chair sensing unit are similar to those that are detected by the predicate EarlySense Bed Sensor and thus the performance of the Chair Sensing Unit is equivalent to the performance of the Bed Sensing Unit and the performance of the chair sensor is not affected by the new design that includes insertion of the sensor into a cushion (rather than insertion of the sensor under a bed mattress)."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Bench Testing" which involved "Performance tests were performed with signals simulating physiological patient signals". No information is provided regarding the sample size of these simulated signals or their provenance (e.g., country of origin, retrospective/prospective). This was a bench test, not human-subject testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable as the study described is bench testing using simulated physiological signals, not human data requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable, as there was no human-subject test set requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned or performed. The submission focuses on validating the device itself, not on evaluating its impact on human reader performance.
6. Standalone Performance Study (Algorithm Only)
The testing described (bench testing with simulated signals) serves as a standalone performance evaluation of the device's ability to detect and transmit signals, and the system's software to analyze these signals. The document states: "The system's detection algorithms differentiate between large body movements, breathing movements and the cardioballistic effect, and thus compute the continuous heart and respiration rates and the body movement." However, detailed performance metrics (e.g., accuracy against a known true value) are not provided, nor is a specific "standalone study" with quantifiable results reported. The performance is largely inferred as being "equivalent" to the predicate device.
7. Type of Ground Truth Used
For the bench testing, the "ground truth" was likely supplied by the "signals simulating physiological patient signals" themselves, which implies a known input with which the device's output could be compared. The nature or source of these simulated signals is not detailed.
8. Sample Size for the Training Set
No information is provided about a training set since the document describes validation activities for a device accessory, not the development of a new algorithm that would typically require a training set. The underlying algorithms for HR, RR, and movement were likely developed and validated with the predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned for the validation of this accessory. The existing algorithms from the predicate device (K120465) are utilized.
§ 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).