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The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is used with compatible bed system models and is intended for continuous measurement of respiration rate and heart rate in an automatic, contact-less manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 lbs (318 kg).

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® is designed for continuous and contact-free measurement of heart and respiratory rate. This device is used with a hospital bed system which is exempt from premarket submission requirements. The Bed Sensing Unit (sensor) attaches to the bed frame and plugs into the bed to both receive power and to transmit data to the bed's graphical user interface/display unit. Additionally, the System can send alarms to an existing hardwired Nurse Call system, speakers, and/or on/off alarm lights within a bed system. The healthcare professional is able to adjust monitoring parameters by interacting with the bed's graphical user interface/display. These parameters include alarm thresholds, display settings, and alarm configurations. The system provides alarm when patient heart rate and/or respiratory rate excurse above or below the predefined thresholds.

The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® consists of:

• . The Bed Sensing Unit, placed on the bed frame under the mattress
• . Software for data analysis, display, and input
• . The device hardware, specifically the connection between the sensor and appropriate bed system

The System also uses the graphical user interface of an appropriate bed system.

The data provided by this system is intended to provide trending information on monitored parameters which should be interpreted by a healthcare professional only. The Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® has not been studied on any specific patient group, nor has it been studied as a diagnostic tool for any specific disease or medical condition. It is meant as an adjunctive tool only for measuring respiration rate and heart rate. The system helps healthcare professionals detect unanticipated patient deterioration quickly by providing heart and respiratory rate continuously rather than through standard periodic caregiver rounding.

The provided text describes the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® and its substantial equivalence to a predicate device (EarlySense® Insight System, K152911). It highlights several performance tests, but explicitly states "No clinical testing was performed." and instead focuses on demonstrating equivalence to the predicate device. Therefore, the information needed to fully answer some of the questions, particularly those related to human-in-the-loop performance and expert-established ground truth from a clinical study, is not present in this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not provide a specific table of defined acceptance criteria (e.g., target accuracy percentages for respiration rate) and corresponding reported performance metrics. Instead, it states that "Hill-Rom has verified and validated that the Hill-Rom® Heart and Respiration Rate Monitoring System powered by EarlySense® meets its functional, and performance specifications and requirements." and that "Accuracy Testing" was conducted to determine the accuracy of the system compared to the predicate.

The table below summarizes the measurable performance characteristics mentioned and implies that the device is deemed acceptable if it performs comparably or within the ranges of the predicate device.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the "Accuracy Testing" or "Durability Testing." It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these tests, as the focus is on technical equivalence rather than clinical study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. The testing described focuses on comparing the device's measurements to those of the predicate device or established technical standards, rather than using expert-established ground truth in a clinical context.

4. Adjudication method 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

No MRMC study was performed. The document explicitly states: "No clinical testing was performed." The device is intended as an "adjunctive tool" and "has not been studied on any specific patient group, nor has it been studied as a diagnostic tool for any specific disease or medical condition." Therefore, no effect size for human reader improvement with or without AI assistance is reported.

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

Yes, standalone performance testing was conducted. The "Accuracy Testing" and "Durability Testing" mentioned evaluate the device's (and its algorithms') performance characteristics (e.g., heart rate and respiration rate measurement accuracy, weight bearing capacity) without human intervention in the loop for interpretation or decision-making.

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

The document does not explicitly state the "ground truth" methodology. Instead, the accuracy testing was conducted "to determine the accuracy of the system compared to the predicate." This implies the predicate device's measurements served as a reference for comparison, or the comparison was against a known, controlled input in a laboratory setting for technical accuracy. It is not an expert consensus, pathology, or outcomes data ground truth in a clinical sense.

8. The sample size for the training set

The document does not provide information on the training set sample size. Since the device utilizes proprietary algorithms developed by EarlySense® (the predicate device manufacturer), and the "Software for data analysis is identical to that cleared in K152911," it's highly probable that any algorithm training occurred prior to the development of this specific Hill-Rom product, and details of that training are not included in this submission.

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

This information is not provided. As mentioned above, details about the training of EarlySense's proprietary algorithms are not part of this 510(k) summary.

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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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