(117 days)
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.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Respiration Rate Range | 6 - 45 Breaths/minute | 6 - 45 Breaths/minute |
| Heart Rate Range | 30 – 170 beats per minute | 30 – 170 beats per minute |
| Durability (Weight) | Withstand up to 440 lbs (200 kg) (predicate's limit) | Withstand up to 700 lbs (318 kg) |
| Accuracy Testing | Comparable to predicate device | Conducted and deemed equivalent to predicate |
| Compliance with Standards | Adherence to specified IEC, ISO, AAMI/ANSI standards | Adherence to specified IEC, ISO, AAMI/ANSI standards |
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.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).