(175 days)
The Bedside Paediatric Early Warning System (BedsidePEWS™) is an electronic documentation tool that is designed to be used in conjunction with multi-parameter patient monitoring. It is indicated for use by healthcare professionals with paediatric patients between the ages of term newborn (>37 weeks gestational age) and 18 years, who are hospitalized with any medical or surgical condition.
BedsidePEWS™ allows input by the healthcare professional of commonly recorded vital sign data and provides clinician with a patient status index (the "BedsidePEWS™ score") based on a weighted average of seven vital signs when entered by the clinician, namely Heart Rate, Respiratory Rate, Blood Pressure, Oxygen Saturation, Oxygen Therapy, Respiratory Effort, and Capillary Refill. The "BedsidePEWS™ score" is a single measure of a patient's condition and indicates the variation in the patient's vital signs with respect to normality. BedsidePEWS™ is an adjunct to and is not intended to replace vital signs monitoring.
BedsidePEWS™ is intended for use in wards and the emergency rooms in hospitals that provide care for children between the ages of term newborn (>37 weeks gestational age) and 18 years. It is not intended for use in the Neonatal Intensive Care Unit.
The product is a web-based clinical decision-support tool that can also be run as a standalone application for use on computers running Microsoft Software Operating features with a local network connection, which access medical data. It is also interfaces to other medical automation systems such as Hospital Information System (HIS), Electronic Medical Record (EMR), and Practice Management Software.
The software device consists of a SQL compatible database that provides access to the patient specific information and allows clinicians to input patient data (i.e. heart rate, respiratory rate, blood pressure, oxygen saturation, oxygen therapy, respiratory effort, and capillary refill time) to deliver actionable information, such as recommended follow-up and/or guideline for further and subsequent clinical assessments, and analytics of patients through real-time vital signs monitoring algorithm.
Here's a summary of the acceptance criteria and the study information for the Bedside Paediatric Early Warning System (BedsidePEWS™) based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document does not explicitly state numerical acceptance criteria in a quantitative format for the clinical performance of BedsidePEWS™, such as sensitivity, specificity, or AUC thresholds. Instead, it frames the acceptance criteria in terms of clinical utility and meeting design specifications.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Software Performance | "The device's software development, verification, and validation have been carried out in accordance with FDA guidelines. The software was tested against the established Software Design Specifications for each of the test plans to assure the device performs as intended. The device Hazard analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria of each module and interaction of processes. The BedsidePEWS device passed all testing and supports the claims of substantial equivalence and safe operation." |
| Clinical Utility | "Clinical evaluation of the BedsidePEWS was performed to ensure that the BedsidePEWS software was clinically useful, and would be accepted by the clinical users." |
| Clinical Effectiveness | "The validation of the Bedside PEWS score using the 7-item score successfully quantified severity of illness in routinely monitored hospitalized children and identified critically ill children with at least one hours notice. Overall, the results support that the device can be used to identify a pediatric patient at risk while undergoing routine monitoring in the hospital." |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated numerically. The document mentions "routinely monitored hospitalized children."
- Data Provenance: Not explicitly stated (e.g., country of origin). The study seems to be retrospective, using existing data for "routinely monitored hospitalized children."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the 510(k) summary. The summary refers to the "validation of the Bedside PEWS score" but does not detail the process of establishing ground truth or the involvement of experts in this context for the clinical study mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the 510(k) summary.
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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, an MRMC comparative effectiveness study is not mentioned. The device is a "clinical decision-support tool" that provides a "patient status index" based on input vital signs. It is "an adjunct to and is not intended to replace vital signs monitoring." The study focuses on the accuracy of the device's score in identifying at-risk patients, not on comparing human reader performance with and without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the clinical evaluation described for BedsidePEWS™ appears to be a standalone performance study. The statement "The validation of the Bedside PEWS score using the 7-item score successfully quantified severity of illness... and identified critically ill children with at least one hours notice" indicates the algorithm's performance in identifying risk, independent of a human-in-the-loop scenario. The device itself "allows input by the healthcare professional of commonly recorded vital sign data and provides clinician with a patient status index," suggesting it processes the input data to generate a score.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth seems to be based on the actual "severity of illness" and the occurrence of "critically ill children" among the "routinely monitored hospitalized children." This suggests clinically determined outcomes or classifications of patient severity. More specific details (e.g., specific clinical endpoints, diagnostic criteria for "critically ill") are not provided.
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The sample size for the training set:
- This information is not provided. The document mentions that the system is "statistically derived," but details on the training dataset size are absent.
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How the ground truth for the training set was established:
- This information is not provided.
§ 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).