(55 days)
The EverOn Central Display Station (CDS) is intended to provide secondary display of the information as displayed on multiple individual bed side monitoring units, on a central remote screen. The EverOn CDS is not intended to replace any part of the bed-side patient monitoring procedures. The system can be used in hospitals or hospital type and clinic environment.
The EverOn Central Display Station (CDS) is intended to communicate with multiple EverOn bed-side monitoring devices and remotely display the information as displayed on multiple individual bed side monitoring units, on a central screen. The communication can be performed either via standard wired or via wireless LAN communication.
The transmitted information from Bed-side to CDS includes alert information and physiological parameters. The CDS can also format the alert information as obtained from bed-side units into a message that can be transmitted to external devices that can communicated with the CDS via standard TCP/IP port. Data and report files (.CSV and .PDF) generated at the bed-side units can be retrieved via the CDS by the user and can be downloaded and / or sent for printing from the CDS. The CDS includes standard hardware (PC, communication and IT hardware). EarlySense develops the application software which is used on the system's PC computer (Central Display Station).
The provided document is a 510(k) summary for the EverOn Central Display Station (CDS) with wireless communication capability. This document focuses on demonstrating substantial equivalence to a predicate device and certifying compliance with relevant standards, rather than providing detailed performance data from a clinical study with acceptance criteria in the typical sense for a diagnostic algorithm.
Therefore, many of the requested points regarding acceptance criteria, sample sizes, ground truth establishment, expert qualifications, and specific study types (MRMC, standalone) are not applicable or not explicitly detailed in this type of regulatory submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a table of acceptance criteria and reported device performance in the manner typically seen for diagnostic algorithms. Instead, the "performance data" section focuses on demonstrating the safety and effectiveness of the modification (wireless communication) to an already cleared device and showing compliance with established standards.
The acceptance criteria are implicitly those of the standards met and the successful completion of verification and validation testing, hazard analysis, and full load bench testing.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Compliance with EN/IEC 60601-1-4 (2000) (Safety) | System reviewed for safety; no new safety issues raised. |
| Compliance with ISO 14971-1 (2007) (Risk Management) | Hazard analysis performed, including risk analysis; specific solutions implemented. |
| Compliance with FDA Guidance: "General Principles of Software Validation" (11/1/02) | Comprehensive software verification and validation testing performed. |
| Compliance with IEC 62304:2006 (Software Development Life Cycle) | Software developed according to a defined life cycle. |
| Compliance with IEC 60812 Ed.2:2006 (FMEA) | FMEA procedure used for failure modes and effects analysis. |
| Correct communication between bed-side and CDS with wireless (Performance) | Full load bench testing performed to establish correct communication and performance with wireless. |
| Substantial Equivalence to Predicate Device (Overall) | Believed to be substantially equivalent to the cleared EverOn CDS without wireless, without raising new safety/effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The
full load bench testingimplies a robust simulation or real-world test, but the number of bed-side units or data points is not
quantified. - Data Provenance: Not applicable in the context of a clinical test set. The testing was conducted by EarlySense Ltd.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The performance evaluation was engineering-focused (software verification, bench testing, hazard analysis) rather than clinical. There's no mention of experts establishing clinical ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable. This testing did not involve human interpretation or adjudication in the context of clinical ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is not relevant for a device like the EverOn CDS, which is a display and communication system, not a diagnostic algorithm that assists human readers in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a display system, not a standalone diagnostic algorithm. The performance testing described (software verification, bench testing) could be considered "standalone" in the sense that it evaluates the system's function independently without continuous human interaction during the test, but it is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation was defined by:
- Engineering specifications and requirements (for software verification and validation).
- Expected communication protocols and display accuracy (for bench testing).
- Industry standards for safety, risk management, and software development (EN/IEC 60601-1-4, ISO 14971-1, IEC 62304, IEC 60812).
8. The Sample Size for the Training Set
Not applicable. The EverOn CDS is a software-driven display and communication system, not an AI/Machine Learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).