(320 days)
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
| Acceptance Criteria | Reported Device Performance (Overall Accuracy) |
|---|---|
| EverOn vs. Gold Standard (Adults) | 95.6% |
| EverOn vs. Gold Standard (Children) | 94.8% |
| EverOn vs. Predicate (Compass) (Adults) | 92.3% |
| EverOn vs. Predicate (Compass) (Children) | 90.7% |
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.
§ 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).