(421 days)
Intended Use Statement:
The eCareManager System is a software tool intended for use by trained medical staff providing supplemental remote support to bedside care teams in the management and care of in-hospital patients. The software collects, stores and displays clinical data obtained from the electronic medical record, patient monitoring systems connected through networks. Using this data, clinical decisions are generated that aid in understanding the patient's current condition and changes over time. The eCareManager System does not provide any alarms. It is not intended to replace bedside vital signs alarms or proactive patient care from clinicians.
All information and notifications provided by the eCareManager System are intended to support the judgement of a medical professional and are not intended to be the sole source of information for decision making.
Indications for Use Statement:
The eCareManager software is solely indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
The eCareManager System is a collection of software applications designed to facilitate the delivery of high-quality critical care services with the assistance of a Telehealth Center Program (THC). The THC provides an organizational and technology platform to transform critical care by redesigning the way critical care is structured and managed. The THC Care Team is a multi-professional team that includes both bedside and THC remote clinicians working together to ensure the best care is provided. The eCareManager System provides a robust toolset that helps ICU and Acute Care clinicians plan, document, and standardize care around best practices.
Population management and communications facilitate a collaborative approach to delivery of in-patient care. The system's clinical decision support applications further aid in the proactive delivery of care. Using data received from the hospital's systems, clinical decision support algorithms provide cues that assist in the early detection of changes in patient condition.
The Visicu, Inc. eCareManager 4.5 is a software tool intended for use by trained medical staff to provide supplemental remote support to bedside care teams in the management and care of in-hospital patients. This device generates clinical decision support notifications to aid in understanding the patient's current condition and changes over time, using clinical data from electronic medical records, patient monitoring systems, and ancillary systems. It is not intended to provide alarms or replace bedside vital signs alarms or proactive patient care from clinicians. The information and notifications are meant to support the judgment of a medical professional and are not the sole source for decision-making. The software is indicated for use in hospital environments or remote locations with clinical professionals and is not for home use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria for device performance in a table format. Instead, it relies on a qualitative assessment of successful completion of verification and validation activities. The "Reported Device Performance" is implied by the statement "All predetermined acceptance criteria were met, demonstrating that the device performs appropriately per defined specifications, and correctly incorporates all required safety mitigations."
However, the document mentions two key device functions under review: Automated Acuity and Discharge Readiness Score, suggesting these would have had specific performance requirements, though not detailed here. The "Comparisons of Technological Characteristics" section also outlines new features and enhancements, and their successful implementation implies they met their intended design specifications.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a separate "test set" sample size in terms of patient data. The non-clinical testing described focuses on software verification and validation activities. It states that "eCareManager was tested in accordance with Philips verification processes" and "Software verification and validation tests were successfully executed on the eCareManager." This implies that the validation was conducted on the software itself rather than a specific patient data set. There is no mention of the country of origin of data or whether it was retrospective or prospective, as the testing was primarily on the software functionality.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish a "ground truth" for a patient-data-based test set, as the testing described is primarily software verification and validation. While the device's purpose is to aid medical professionals, the validation focuses on the software's functional correctness rather than the accuracy of its clinical decision support against expert consensus in a clinical setting.
4. Adjudication Method for the Test Set:
No adjudication method is described, as the non-clinical testing detailed does not involve human readers evaluating output against a ground truth from patient data. The testing was focused on software functionality and compliance with specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No MRMC comparative effectiveness study is mentioned. The document primarily reports on software verification and validation activities, not a study involving human readers with and without AI assistance to assess improved effectiveness.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, the testing described appears to be primarily stand-alone algorithm performance. The "Non-Clinical Testing" section details "Software verification and validation activities" including "Unit Testing, Integration Testing and System Level Testing (Functional and Regression Testing, Migration Testing, Localization Testing, Performance/Load Testing and Compatibility Testing included the following System Level Testing: User/Commercial Requirements Validation, Essential Performance Testing and Human Factors/Usability Testing." This indicates that the software's functionality was evaluated independently to ensure it performed according to its defined specifications and safety mitigations.
7. The Type of Ground Truth Used:
For the software verification and validation, the "ground truth" would be the defined specifications and requirements for the eCareManager 4.5 software. The success of the testing means that the software's outputs and behaviors matched these predetermined specifications.
8. The Sample Size for the Training Set:
The document does not provide information about a "training set" sample size. The eCareManager system uses clinical data from electronic medical records and patient monitoring systems to generate clinical decision support notifications. While this implies underlying algorithms that may have been trained, the regulatory submission documentation focuses on the verification and validation of the software system as a whole, rather than the development and training of specific AI/ML models within it. Thus, a training set is not mentioned.
9. How the Ground Truth for the Training Set Was Established:
Since no training set is described in the provided document, there is no information on how its ground truth was established.
§ 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).