(29 days)
The Hillrom 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 (RR) in an automatic, contactless 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 lb (318 kg).
The Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense is designed for continuous and contact-free measurement of heart and respiratory rate (also referred to as Bed Sensing Unit). This device is used with a hospital bed system which is exempt from 510(k) premarket submission requirements. The Bed Sensing Unit (sensor) plugs into the bed frame to both receive power and to transmit data. Data from the System is available on the bed's graphical caregiver interface (GCI)/display unit and can be transmitted through wired and wireless communication channels to Hillrom Connectivity Solution (also known as (aka)- Hillrom Digital Health Gateway) for display, use, and storage. Additionally, the System can transmit alerts via Bloetooth to an existing hardwired Nurse Call system, speakers, and/or on/off alert lights within a bed system. The healthcare professional can adjust monitoring parameters by interacting with the bed's GCI. These parameters include hospital-defined alert thresholds, display settings, and alert configurations. The system provides alerts when patient heart rate and/or respiratory rate are recorded that are above or below the predefined thresholds.
The Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense consists of:
- . The Bed Sensing Unit, placed on a bed frame under the mattress
- This is functionally identical to the sensor cleared in K202018 -
- Software for data analysis, display, and input ●
- The device hardware, specifically the connection between the sensor and • appropriate bed system
- The hardware for the device is identical to that cleared in K202018 -
- The Heart and Respiration Rate Monitoring System also uses certain hardware, such as the graphical caregiver interface and wireless communication module, of an appropriate bed system
- Hillrom Connectivity Solution (aka Hillrom Digital Health Gateway) .
- The Hillrom Digital Health Gateway consists of gateways that make information about the bed and patient available to 3rd party applications. This is functionally identical to that cleared in K202018.
The provided text focuses on the substantial equivalence of the Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense to a predicate device, K202018. It does not contain a dedicated study section detailing acceptance criteria for the device itself or a study proving those criteria are met.
However, the "Comparison of Subject to Predicate: Technology and Specifications" table (Table 2) lists certain performance characteristics identified as "Accuracy" for Heart Rate and Respiratory Rate, which can be interpreted as acceptance criteria based on the predicate device's established performance.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the comparison table (Table 2), the "Accuracy" values for the subject device are stated to be the same as the predicate device. Therefore, we can infer the acceptance criteria for these specific metrics by looking at the predicate's reported performance.
| Metric | Acceptance Criteria (Inferred from Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Total System Accuracy (including undetected signals) | 90% (measured as ±10% of predicate) | 90% (measured as ±10% of predicate) |
| Heart Rate Accuracy | ±4% or ±5 BPM whichever is greater | ±4% or ±5 BPM whichever is greater |
| Respiratory Rate Accuracy | ±4% or ±1.5 Br./min whichever is greater | ±4% or ±1.5 Br./min whichever is greater |
2. Sample size used for the test set and the data provenance
The document does not provide specific details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the accuracy testing of the subject device. It states, "Extensive testing has been conducted on the finished Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense and demonstrates that the System is as safe and as effective as the predicate device." However, no specifics about these "extensive tests" are provided beyond non-clinical tests like EMC, Software V&V, Cybersecurity, and Coexistence testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number or qualifications of experts used to establish ground truth for the performance metrics listed. It does not describe how the ground truth for the accuracy measurements (Heart Rate and Respiratory Rate) was established.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not describe any adjudication method used for establishing ground truth or evaluating the test set performance.
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
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a monitoring system and does not typically involve human "readers" or an AI component that assists in interpreting medical images or complex data in a way that would be assessed by MRMC.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The entire description of the device focuses on its standalone performance in continuously measuring heart and respiration rates. The accuracy values provided are for the system itself. Therefore, it can be inferred that standalone performance testing was done for the algorithm. However, no specific study details are provided, only that the reported accuracy performance (same as predicate) was met.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used for measuring the Heart Rate and Respiratory Rate accuracy. Given the nature of vital sign monitoring, the ground truth would typically be established by simultaneously recorded, highly accurate reference devices (e.g., ECG for heart rate, capnography or direct spirometry for respiration rate) in a controlled environment, rather than expert consensus, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
The document describes the device as being "powered by EarlySense" and states that "The software for data analysis is identical to that cleared in K202018." This suggests the core algorithms and models were developed and potentially trained earlier as part of the predicate device's development. However, the document does not provide information on the sample size used for the training set.
9. How the ground truth for the training set was established
Similar to point 8, the document states the software and analysis algorithms developed by EarlySense are identical to the predicate device. There is no information provided within this document about how the ground truth for any potential training set for these algorithms was established.
§ 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).