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The EarlySense Central Display System is intended to provide remote central monitoring and display of information as recorded by multiple EarlySense bedside units, on a central remote screen. The system can be used in hospital type and clinic environment.

The EarlySense Central Display System (CDS) is a system which includes EarlySense developed application software, installed on standard off-the-shelf PC computer with a computer screen. The system also uses standard off-the shelf communication and IT hardware.

The CDS is intended to communicate with multiple EarlySense Bedside monitoring devices (cleared as K131379 and K120465), in order to display the information as it is monitored on the bedside units on a central remote screen. The users can access the user interface of the individual bedside units via the CDS's screen and view or adjust bedside units' parameters, e.g. change settable parameters, such as alert thresholds.

The communication is performed through TCP/IP protocol, either via standard wired or via wireless LAN communication. The transmitted information from Bedside Unit to CDS and backwards includes alert information and physiological parameters (such as patient in / out of bed status, heart rate, respiration rate, motion rate and Sp02, if monitored at bedside unit, as well as room and bed number, etc.). 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. In addition, a possibility to remotely view the CDS screen from a tablet or additional PC computer exists.

The accessories that can be possibly used with CDS system include:

• . Computer Screen
• . Keyboard and mouse
• Additional hallway LCD/LED screen .
• . External communication devices, like: pagers, etc.
• Tablet or additional PC computer (to remotely view the CDS computer . screen)

The provided text describes the EarlySense Central Display System (CDS) and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer most of the questions about acceptance criteria and a specific study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than a detailed report of a performance study with specific acceptance criteria.

Here's what can be extracted and what is missing:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The document states that the modified EarlySense CDS System was subject to "the whole range of verification and validation tests," including:

• Risk analysis
• Software Verification and Validation
• Performance Bench Testing

However, it does not specify what the acceptance criteria for these tests were, nor does it present the actual performance results in relation to such criteria. The conclusion simply states that the non-clinical tests demonstrate the device is "as safe, as effective, and performs as well as or better than the predicate devices."

Regarding a specific study proving the device meets acceptance criteria:

The document mentions "Performance Bench Testing" but provides no details on its methodology, sample size, or specific outcomes.

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. The document mentions "Performance Bench Testing" but does not detail the sample size or data provenance.

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 mention of "Performance Bench Testing" does not include details on how ground truth was established or by whom. The device is a central display system for physiological parameters, not an AI diagnostic device that typically requires expert-established ground truth in the same way.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided.

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

This information is not provided. The device is a central display system for monitoring, not an AI for interpretation or assisting human readers in a diagnostic task that would typically warrant a MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document implies "Performance Bench Testing" was done for the software algorithm as part of the system. The device itself is essentially a standalone software application displaying data from other bedside units. However, specific details of this testing (e.g., how "standalone" was measured) are not provided. The comparison is made against predicate devices which are also central display systems, implying a functional comparison rather than a human-in-the-loop versus algorithm-only comparison.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not provided. For a central display system, the "ground truth" for performance testing would likely involve ensuring accurate transmission and display of physiological parameters from the bedside units. This would typically be verified against the direct output of the bedside units or simulated data, rather than expert consensus or pathology.

8. The sample size for the training set

This information is not provided. The device is described as a software application that displays data from other units and allows for parameter adjustment. It does not appear to be an AI/ML device that requires a "training set" in the conventional sense for learning patterns or making predictions. It's a display and control interface.

9. How the ground truth for the training set was established

This information is not provided and is likely not applicable, as the device is not described as an AI/ML system requiring a training set with established ground truth.

Summary of what is present:

• Device Description: The EarlySense Central Display System (CDS) is a software application installed on standard off-the-shelf PC hardware. It communicates with multiple EarlySense Bedside monitoring devices to remotely display physiological information (heart rate, respiration rate, motion rate, SpO2, in/out of bed status, etc.) and allows remote adjustment of bedside unit parameters.
• Purpose of Review: This is a 510(k) premarket notification for an updated software version (1.1.2.2) of the CDS, demonstrating substantial equivalence to predicate devices (EarlySense Central Display Station, K121885, and Connex Central Station, K132807).
• Performance Data Mentioned: The system underwent Risk analysis, Software Verification and Validation, and Performance Bench Testing.
• Conclusion: Non-clinical tests demonstrate the device is "as safe, as effective, and performs as well as or better than the predicate devices."

The document focuses on the regulatory pathway of substantial equivalence rather than a detailed scientific and clinical performance study report.

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The EarlySense Chair Sensing Unit is intended to be used for continuous measurement of Respiration Rate, Heart Rate and Movement, in an automatic contact-less manner, at home, hospital or clinic setting. The sensor is indicated for use in children, adolescents and adults. The operation of the EarlySense system has been studied in children (weight ≥ 10 Kg) and adults (weight

EarlySense is submitting a new accessory for contactless measurement of heart, respiratory rate and motion, the Chair Sensing Unit. The Chair Sensing Unit, similar to its predicate, the EarlySense Bed Sensing Unit cleared as part of previous EarlySense system submissions (K070375, K082465, K092062, K120465), is intended for continuous measurement of Heart Rate, Respiration Rate and motion while the patient is resting.

The EarlySense Chair sensing unit is comprised of the following components:

1. Sensor: that includes piezoelectric elements incorporated into a plate

2. A cushion made of foam into which the sensor is inserted into - so not to be touched by the patient.

The Chair sensing unit should be connected to a bedside unit that receives and analyzes the signals from the Chair sensing unit to measure and display heart rate, respiratory rate and motion.

The EarlySense Chair Sensing Unit is an accessory to the EarlySense System for continuous, contactless measurement of Respiration Rate, Heart Rate, and Movement. The 510(k) summary provided does not contain specific, quantitative acceptance criteria or detailed results of a clinical study that proves the device meets such criteria. Instead, it relies on bench testing and comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No specific quantitative acceptance criteria or detailed performance data (e.g., accuracy, precision) for the EarlySense Chair Sensing Unit are explicitly stated in the document. The document primarily focuses on establishing substantial equivalence to the predicate device through bench testing rather than reporting precise performance metrics against pre-defined targets.

The general conclusion from bench testing is that: "the signals as detected by the chair sensing unit are similar to those that are detected by the predicate EarlySense Bed Sensor and thus the performance of the Chair Sensing Unit is equivalent to the performance of the Bed Sensing Unit and the performance of the chair sensor is not affected by the new design that includes insertion of the sensor into a cushion (rather than insertion of the sensor under a bed mattress)."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Bench Testing" which involved "Performance tests were performed with signals simulating physiological patient signals". No information is provided regarding the sample size of these simulated signals or their provenance (e.g., country of origin, retrospective/prospective). This was a bench test, not human-subject testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the study described is bench testing using simulated physiological signals, not human data requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as there was no human-subject test set requiring adjudication.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned or performed. The submission focuses on validating the device itself, not on evaluating its impact on human reader performance.

6. Standalone Performance Study (Algorithm Only)

The testing described (bench testing with simulated signals) serves as a standalone performance evaluation of the device's ability to detect and transmit signals, and the system's software to analyze these signals. The document states: "The system's detection algorithms differentiate between large body movements, breathing movements and the cardioballistic effect, and thus compute the continuous heart and respiration rates and the body movement." However, detailed performance metrics (e.g., accuracy against a known true value) are not provided, nor is a specific "standalone study" with quantifiable results reported. The performance is largely inferred as being "equivalent" to the predicate device.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" was likely supplied by the "signals simulating physiological patient signals" themselves, which implies a known input with which the device's output could be compared. The nature or source of these simulated signals is not detailed.

8. Sample Size for the Training Set

No information is provided about a training set since the document describes validation activities for a device accessory, not the development of a new algorithm that would typically require a training set. The underlying algorithms for HR, RR, and movement were likely developed and validated with the predicate device.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set is mentioned for the validation of this accessory. The existing algorithms from the predicate device (K120465) are utilized.

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The EarlySense 2.0 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 EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight

The modified EarlySense System 2.0 is similar to cleared (EverOn™1.0S) System (K120465) except for the hardware and software changes that are described below.

The cleared (K120465) EarlySense (EverOn™1.0S) System is comprised of the following components:

1. A Bed Sensing Unit based on piezoelectric sensing

2. A Bedside Unit incorporating a medical grade power supply and the following modules:

A Signal Sampling Module consisting of amplifiers, filters and analog to a. digital converter as well as a microprocessor designated to transfer the sampled data to the Signal Processing Module, and

b. A Signal Processing and Display Module.

3. An Optional Oximetry OEM module with communication interface and compatible marketed sensors.

The EarlySense System 2.0 is a modified version of the EarlySense (EverOn™1.0S) System (K120465). The changes include modifications to the Bed Sensing Unit (adding an accelerometer, piezoelectric polymer sensor, and base plate handles) and the Bedside Unit (dimensional changes, replacement of power supply, speaker's buzzer, communication card, fan, additional USB and sensor's connectors, and software update to version 1.0.3).

Acceptance Criteria and Device Performance:

The provided 510(k) summary does not explicitly list numerical acceptance criteria or detail the specific performance metrics achieved by the EarlySense System 2.0. Instead, it states that the device was subject to various verification and validation tests and that the modifications "did not affect its performance, effectiveness or safety." The submission aimed to demonstrate substantial equivalence to the predicate device (K120465).

The performance claims rely on the device maintaining the same functionality and performance as its predicate, which was already cleared. The performance criteria for the predicate device would be relevant here, but are not provided in this document.

Studies and Ground Truth Information:

The document focuses on demonstrating that the modifications did not negatively impact the performance of the device and thus, it remains substantially equivalent to the cleared predicate. It does not present new clinical studies with detailed acceptance criteria and performance results in the same way a de novo submission might.

Here's an analysis of the provided information concerning studies:

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The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:

• noninvasive blood pressure,
• pulse rate,
• noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
• body temperature in normal and axillary modes.

The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.

The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.

The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.

The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Optional compatible weight scales (e.g., Health o meter") can be used for height, and BMI input.

The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.

The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight ≥ 10 Kg) and adults (weight

The Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) is designed to provide a scalable, modular system of components which can be configured to address the needs for vital signs spot checking and continuous monitoring.

The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing modules installed into the base unit including;

• NIBP Module provides measurements of noninvasive blood pressure and pulse rate.
• SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin.
• The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic respiration rate (RRa),
• The Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients.
• The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements,
• The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement. The addition of this Module is the subject of this 510(k).

The CVSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner. IR temperature, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications, including, for example, to electronic record systems and for remote display and alarming (e.g., central station).

This looks like a 510(k) summary for the Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) that focuses on the addition of the EarlySense module. The submission claims substantial equivalence to a previously cleared device (K121013), not necessarily claiming novel performance that requires significant clinical studies.

Here's an analysis of the provided text regarding acceptance criteria and studies:

Key Takeaway from the Document:

The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." (Page 8). This means that for the subject device (the CVSM with the integrated EarlySense module), there wasn't a new clinical study to establish its performance. Instead, it relies on substantial equivalence to a predicate device and bench testing for the integration of the EarlySense module. The EarlySense module itself was previously cleared in a separate 510(k) (K120465), and the performance claims for respiration rate, heart rate, and patient movement from that clearance are what are being incorporated.

Therefore, the acceptance criteria and performance data for the overall device are generally based on the predicate device's performance, as well as the previously cleared EarlySense module's performance, and the current submission primarily addresses the safety and effectiveness of the integration via non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Since no new clinical studies were performed for this specific 510(k), the "reported device performance" for the subject device (CVSM with EarlySense module) relies on the performance characteristics inherited from the predicate device and the previously cleared EarlySense module.

Note: The acceptance criteria for the EarlySense module's measurements (Respiration Rate, Heart Rate, Patient Movement) are those from its original 510(k) clearance (K120465), which are being appended to the CVSM's indications for use.

2. Sample Size Used for the Test Set and Data Provenance

As explicitly stated: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data."

Therefore, there is no "test set" in the context of new clinical performance data generated for this 510(k) submission.

The section "Clinical Performance Data" directly states this lack of new clinical studies. The performance of the EarlySense module for respiration rate, heart rate, and patient movement was established in its prior 510(k) (K120465), and the current submission is for the integration of this already-cleared module into the CVSM.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable, as no new clinical studies were conducted for this submission that would require establishing a ground truth with experts. The performance data for the EarlySense module itself would have been established during its original K120465 clearance process.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical studies were conducted for this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done as part of this 510(k) submission. The submission explicitly states "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." This type of study would be classified as a clinical study.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

The document indicates that the "EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner." This implies a standalone algorithm for these measurements. However, no new standalone performance study was done for this submission. The performance characteristics of the EarlySense module were presumably established during its original K120465 clearance. This 510(k) focuses on the integration of this already-cleared module into the Welch Allyn CVSM.

The "Non-Clinical Tests" section lists several bench tests (e.g., Electromagnetic Compatibility, Shock and Vibration, Thermal Shock, Operating Environmental Test, Battery Use Cycles, Electrical Safety, Industrial Design Specification Analysis, Shipping Container Labeling, BOM Verification, Design Validation, Directions For Use Validation). These are engineering and usability tests to ensure the integrated system functions safely and effectively, but they are not standalone performance studies of the measurement algorithms themselves.

7. The type of ground truth used

Not applicable for this 510(k) submission, as no new clinical studies were conducted. The ground truth for the EarlySense module's measurements (Respiration Rate, Heart Rate, Patient Movement) would have been established during its original K120465 clearance, likely using reference methods or gold standards for vital sign measurement.

8. The sample size for the training set

Not applicable for this 510(k) submission, as no new clinical studies were conducted. Any training data for the EarlySense algorithms would have been part of its original development and clearance (K120465).

9. How the ground truth for the training set was established

Not applicable for this 510(k) submission. This information would pertain to the original development and clearance of the EarlySense module (K120465).

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