(74 days)
The EarlySense (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 EarlySense (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 EarlySense Central Display Station (CDS) is intended to communicate with multiple EarlySense Bedside monitoring devices and remotely display, on a central screen, the information as displayed on the individual Bedside monitoring units. The communication can be performed either via standard wired or via wireless LAN communication. The transmitted information from Bedside to CDS includes alert information and physiological parameters. The CDS can also format the alert information as obtained from Bedside units into a message that can be transmitted to external devices that can communicate with the CDS via standard TCP/IP port. Data and report files (.CSV and .PDF) generated at the Bedside units can be retrieved via the CDS by the user and can be downloaded and for sent from the CDS. The CDS can also collectively generate, for all Bedside units connected to a CDS, unified tabulated reports that indicate the settings/alerts of each bedside unit. 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), equipped with Linux Debian operating system.
The provided text is a 510(k) summary for the EarlySense Central Display Station (CDS). It describes the device, its intended use, and argues for substantial equivalence to a predicate device. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical or technical performance study would.
The document states: "Performance testing, inclusive of software verification and Full load bench testing was performed to verify that all modifications introduced in the device as compared to its predicate device did not raise any new safety and effectiveness issues." This sentence indicates that some testing was done, but it does not describe the specific acceptance criteria or the reported device performance in a quantitative manner.
Therefore, much of the requested information cannot be extracted directly from this 510(k) summary. I will answer based on the information available and indicate where information is not provided.
Acceptance Criteria and Study Information for EarlySense Central Display Station (CDS)
Based on the provided 510(k) summary, the device is a Central Display Station (CDS) that remotely displays information from bedside monitoring units. The primary claim for this submission is substantial equivalence to a predicate device (EverOn Central Display Station (CDS) cleared under K110521) after an operating system change (Windows XP to Linux Debian) and minor GUI modifications.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence: Display information from multiple individual bedside monitoring units on a central remote screen. | The modified CDS continues to display information as displayed on individual Bedside monitoring units. It can also display additional physiological parameters (e.g., SpO2) and generate new tabulated reports. |
| Safety and Effectiveness: No new safety and effectiveness issues raised due to modifications (OS change, GUI, additional parameters/reports). | "Performance testing, inclusive of software verification and Full load bench testing was performed to verify that all modifications introduced in the device as compared to its predicate device did not raise any new safety and effectiveness issues." |
| Communication: Ability to communicate via standard wired or wireless LAN. | Communication capabilities maintained, as this was not a modified aspect of the core communication protocol described. |
| Alert Transmission: Format and transmit alert information to external devices via TCP/IP. | This functionality is maintained and available. |
| Data Retrieval: Retrieve and download/send .CSV and .PDF report files. | This functionality is maintained and available. |
Note: The 510(k) summary describes functional modifications and states that performance testing was conducted to ensure no new safety or effectiveness issues. However, it does not provide specific, quantifiable acceptance criteria (e.g., "display latency less than X milliseconds," "data accuracy within Y%") or detailed performance data (e.g., "average latency was Z milliseconds"). The acceptance criteria are largely inferred from the claim of substantial equivalence and the scope of modifications.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document mentions "Performance testing, inclusive of software verification and Full load bench testing" but does not detail the sample size or provenance of any data used for these tests. Given the nature of a CDS (secondary display), the "test set" would likely refer to the configurations and scenarios tested rather than a patient data set for clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The device is a display and communication system, not an interpretive AI device requiring expert ground truth for diagnostic accuracy. The testing would likely involve software engineers and potentially clinical users validating display accuracy and functionality.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As explained above, the nature of the device's function does not typically involve expert adjudication in the way an imaging or diagnostic AI would.
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
An MRMC comparative effectiveness study was not done. This device is a display and communication system, and not an AI or diagnostic tool designed to directly improve human reader performance in interpreting medical cases. No "AI assistance" is mentioned as a feature of the device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device does not contain an "algorithm" in the sense of a diagnostic or interpretive AI. It is a display and communication system that provides information for human-in-the-loop patient monitoring. Therefore, a standalone effectiveness study of an algorithm is not applicable and was not done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" (e.g., for diagnostic accuracy) is not applicable in the context of this device. The "truth" would refer to the accurate and timely display of physiological parameters and alerts as generated by the bedside monitoring units. The testing would verify that the CDS accurately reflects the source data.
8. The sample size for the training set
This device is not an AI or machine learning system that requires a "training set." Therefore, this information is not applicable and not provided.
9. How the ground truth for the training set was established
As there is no training set for an AI algorithm, this information is not applicable and not provided.
§ 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).