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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(K) SUMMARY EarlySense Ltd.

SEP 10 2012

EarlySense Central Display System (CDS)

Applicant's Name: EarlySense Ltd. 12 Tzvi st. Ramat Gan 52504, Israel Tel: +972-3-7522330 Fax: +972-3-7522340

Contact Person: Dalia Argaman EarlySense Ltd. 12 Tzvi Street. Ramat Gan 52504, Israel Tel: +972-3-752-2330 Fax: +972-3-752-2340 email: Dalia.Argaman@EarlySense.com
Date Prepared: June 24, 2012

Trade Name: EarlySense Central Display Station

Classification Name: System Network and communication, physiological monitors (Product Code MSX)

Class: I I
Regulation Number: 870.2300
Predicate Device: EverOn Central Display Station (CDS) (EarlySense Ltd); cleared under K 1 10521

Device Description:

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

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.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.

Intended Use/ Indications for Use:

Substantial Equivalence

The EarlySense CDS on Linux operating system platform has the same technological characteristics, mode of operation, performance characteristics, and identical intended use and indications for use of its predicate device (K110521).

The operating system of the CDS was modified from Windows XP to Linux Debian. The modified CDS can also, display additional physiological parameters that might be displayed on EarlySense bedside unit (e.g., SpO2). Additional reports displaying the settings/alerts from all connected Bedside units collectively, in tabulated format, are available. Additionally, minor GUI modifications for user convenience were performed.

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.

Based on the design verification and validation processes performed as a result of risk assessment and results of the testing performed, EarlySense Ltd. believes that the modified CDS is substantially equivalent to the cleared EverOn CDS without raising new safety and/or effectiveness issues.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

SEP 10 2012

EarlySense LTD. Dalia Argaman 12 Tzvi St Ramat Gan 52504, Israel

Re: K121885

EarlySense Central Display Station Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Monitor Network and Communication System Regulatory Class: Class II Product Code: MSX Dated: August 7, 2012 Received: August 13, 2012

Dear Ms. Dalia Argaman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 t CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):_Κ (Σιδιαίδια

Device Name:

Indications For Use:

AND/OR Over-The-Counter Use Prescription Use イ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 14121885

Regulation Number and Section

§ 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).