(280 days)
The 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 ES-16 System has been studied in children (weight ≥ 10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition.
The EarlySense™ ES-16 System consists of the following main components:
- . A Sensing Unit placed under the mattress pad.
- . A Control Unit (Bedside Unit).
- Proprietary recording and data analysis software operating under 트 Microsoft® Windows™ CE.
The under mattress Sensing Unit includes a piezoelectric sensor, which converts the detected respiration- and heart beat-related mechanical movements into an electric signal. The Control Unit receives the electric signals, processes them and finally calculates, logs and displays the patient's respiration rate and hear rate.
The EarlySense™ System is designed for continuous and contact-less monitoring of respiration and heart rates during sleep or resting condition, and it automatically starts measuring whenever the patient is in bed under resting or sleeping conditions. The data acquired by the System should be analyzed by a health care practitioner either in realtime (e.g. when monitoring is performed in the clinic), or off-line, after the monitoring session (e.g. when monitoring is performed at home).
The provided text describes a 510(k) submission for the EarlySense™ ES-16 System, a breathing frequency monitor. However, it does not contain specific acceptance criteria or details of a study with reported device performance metrics against those criteria. The document focuses on establishing substantial equivalence to predicate devices.
Therefore, I cannot populate a table of acceptance criteria and reported device performance from this input. The text states: "Tests results indicated that the EarlySense™ ES-16 System performs according to its specifications and accurately detects respiration rate and heart rate in comparison to its predicate devices." but does not provide the specifications or quantitative accuracy results.
Below is a breakdown of what can be extracted from the document regarding the study and ground truth, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the provided document. The document mentions "performs according to its specifications" but the specifications themselves are not detailed.
- Reported Device Performance: Not explicitly stated in quantitative terms. The document concludes "accurately detects respiration rate and heart rate in comparison to its predicate devices."
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document indicates the system "has been studied in children (weight ≥ 10 Kg) and adults (weight ≤111 Kg) during sleep and resting condition."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "simultaneous monitoring with the EarlySense™ System and its predicate device," implying a clinical setting. It does not specify if it was retrospective or prospective, but the nature of simultaneous monitoring suggests prospective data collection for the test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
- Ground Truth Establishment for Test Set: The ground truth for the test set was established by "simultaneous monitoring with the EarlySense™ System and its predicate device". The predicate devices (Embla N7000 and LifeShirt System) are widely recognized as established methods for monitoring breathing and heart rate, thus serving as the reference standard or "ground truth" for comparison.
4. Adjudication method for the test set
- Not mentioned. The comparison was directly against predicate devices.
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
- No MRMC comparative effectiveness study was done. This device is a monitor producing objective measurements, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, a standalone study was done. The device, the EarlySense™ ES-16 System, is a "Breathing frequency monitor" 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 "Control Unit receives the electric signals, processes them and finally calculates, logs and displays the patient's respiration rate and hear rate." This describes a standalone algorithm-only performance, where human interaction primarily involves analysis of the already calculated data.
7. The type of ground truth used
- Comparative Ground Truth: The ground truth for the clinical testing was established by using "simultaneous monitoring with the EarlySense™ System and its predicate device". The predicate devices (Embla N7000 and LifeShirt System) served as the reference standard for respiration and heart rate measurements.
8. The sample size for the training set
- Not mentioned. The document does not distinguish between training and test sets in terms of sample size for human subjects. However, it does mention "bench testing including a comparison to a respiration and heart beat simulator" which could be part of development/training.
9. How the ground truth for the training set was established
- Not explicitly detailed. For human subject data, it would logically follow the method for the test set (comparison to predicate devices). For bench testing, a "respiration and heart beat simulator" was used as the ground truth.
§ 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).