(217 days)
The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to compute a patient status index. The Rothman Index is a single measure of a patient's physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values.
PeraServer is indicated for use wherever there is interest in generating Rothman Index (RI) scores and/or associated configurable warnings.
PeraTrend is indicated for use by healthcare providers whenever there is need for displaying and/or trending RI scores and displaying associated configurable warning states as an adjunct to clinical decision support.
PeraServer/PeraTrend is intended for the care of patients throughout the hospital setting (e.g., in the emergency department, on the wards, in intensive care units).
The Rothman Index score is validated for use with neonatal, pediatric, and adult patients. It is an adjunct-to and is not intended to replace vital signs monitoring and is not intended for use in the Neonatal Intensive Care Unit.
The subject of this submission is the PeraServer and PeraTrend System, consisting of:
- PeraServer a backend hardware/software platform that imports electronic health record ● (EHR) data, which are used to compute and store Rothman Index (RI) scores and related measures
- PeraTrend – the frontend web-based user interfaces for displaying RI scores and related measures, as well as simple manipulations of the display (i.e., graphical representations over time, comparison of Rothman Index scores and input measures)
PeraServer and PeraTrend are software-only devices that are installed on user-provided hardware.
The PeraServer™ and PeraTrend™ System calculates a patient's physiologic condition using the Rothman Index (RI) based on vital signs, nursing assessments, and lab data. The system is intended for use by healthcare providers as an adjunct to clinical decision support in various hospital settings across neonatal, pediatric, and adult patients, but not in the Neonatal Intensive Care Unit.
The submission references three retrospective studies to demonstrate the validity of the RI score and establish substantial equivalence to the predicate device, BedsidePEWS (K124038).
Acceptance Criteria and Device Performance:
The document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics. Instead, it refers to three studies that "demonstrate that the performance of the PeraServer and PeraTrend System is equivalent to that of the predicate device for both pediatric and adult populations." The studies likely showed the RI score's accuracy or efficacy in reflecting patient condition and predicting outcomes.
Key information extracted from the provided text:
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Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in a table format within the given document. The document states that the performance of the PeraServer and PeraTrend System has been validated and demonstrated to be equivalent to the predicate device through the described studies.
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Sample sizes used for the test set and data provenance:
- The document refers to three retrospective studies:
- Rothman et. al (2013) for the adult RI score.
- Finlay et. al (2014) for a comparison between RI scores and MEWS.
- Rothman et. al (2017) for the pediatric RI score.
- Specific sample sizes for the test sets are not provided in this document.
- Data Provenance: The studies are described as retrospective, implying the data was collected from past patient records. The country of origin of the data is not specified.
- The document refers to three retrospective studies:
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Number of experts used to establish the ground truth for the test set and their qualifications: This information is not provided in the document.
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Adjudication method for the test set: This information is not provided in the document.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study: An MRMC study is not explicitly mentioned as having been performed. The studies focus on validating the Rothman Index score itself, not on comparing human reader performance with and without AI assistance.
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Standalone (algorithm-only) performance study: Yes, the described studies appear to be evaluating the standalone performance of the Rothman Index algorithm. The document emphasizes the validation of the RI score itself.
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Type of ground truth used:
- The Rothman Index is described as a "single measure of a patient's physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values."
- This suggests that the ground truth used for validation in the studies would likely be patient outcomes data, such as mortality, or other clinically validated indicators of patient deterioration that the RI score is designed to predict or reflect. However, the exact nature of the ground truth (e.g., pathology, expert consensus) is not explicitly stated.
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Sample size for the training set: This information is not provided in the document.
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How the ground truth for the training set was established: This information is not provided in the document. The document only mentions "the mechanics and validation" of the RI score in the context of the retrospective studies.
§ 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).