(333 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 and ancillary systems connected through networks. Using this data, clinical decision support notifications 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 indicated for use in hospital environment or remote locations with clinical professionals. It is not indicated for home use.
The eCareManager (eCM) system is a software platform that enables enterprise telehealth. The system includes an interface to acquire patient data from the electronic medical record and bedside devices. eCM provides a history of the patient population in clinic and provides a clinical decision support feature to aid in the proactive delivery of consultative care for the patient
The provided text describes the eCareManager 4.0.1, a telehealth software, but does not contain a table of acceptance criteria or detailed results of a study proving the device meets specific performance criteria. The document is a 510(k) summary for FDA clearance, focusing on demonstrating substantial equivalence to predicate devices rather than reporting on specific performance metrics against pre-defined acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred regarding performance data and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific acceptance criteria or quantitative reported device performance metrics are explicitly stated in a table format within the provided document. The document primarily focuses on demonstrating substantial equivalence through comparison with predicate devices and mentions that "Verification and validation activities have been conducted to establish the performance, functionality, and usability characteristics of the new device with respect to the predicate, intended use and defined requirements."
It does highlight key features like the Sepsis Screening Prompt and validates its performance against the IntelliVue Protocol Watch SSC. The comparison table (Table 5-2) implies that the eCareManager's sepsis screening model "yielded higher discrimination for identifying severe sepsis than traditional criteria as used in the Intellivue SSC model," suggesting a performance improvement, but without specific metrics or acceptance thresholds.
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Clinical validation for the Philips eCareManager software release 4.0.1 included both model development and post-implementation studies to evaluate the performance of the Sepsis Screening Prompt algorithm." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
The document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. It generally refers to "trained medical staff" and "clinicians" as the intended users and those who would follow up on sepsis assessments.
4. Adjudication Method for the Test Set:
The document does not describe any adjudication method used for establishing ground truth in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on the algorithm's performance and its role in providing "supplemental remote support" and "clinical decision support notifications."
6. Standalone (Algorithm Only) Performance Study:
Yes, a standalone performance evaluation of the Sepsis Screening Prompt algorithm was done. The document states "Clinical validation for the Philips eCareManager software release 4.0.1 included both model development and post-implementation studies to evaluate the performance of the Sepsis Screening Prompt algorithm." The comparison with the IntelliVue Protocol Watch SSC (K113657), which also has a sepsis screening feature, indicates a standalone assessment of the eCareManager's algorithm.
7. Type of Ground Truth Used:
The document itself does not explicitly state the type of ground truth used for the sepsis screening algorithm. However, given that the algorithm is based on "2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med 2003 Vol 31, No.4" and assesses criteria like "Temperature, Heart Rate, Respiratory Rate, White Blood Cell Count/Bands, Mental Status, Serum Glucose, Ileus, INR, Lactate," it is highly probable that the ground truth for training and evaluation was established based on clinical criteria, patient outcomes, and potentially expert clinical review or diagnosis of sepsis. It references "higher discrimination for identifying severe sepsis," which implies a comparison against a clinical gold standard for sepsis diagnosis.
8. Sample Size for the Training Set:
The document does not provide the sample size for the training set used for the model development of the Sepsis Screening Prompt algorithm.
9. How the Ground Truth for the Training Set Was Established:
The document states the sepsis screening criteria are based on the "2001 SCCM/ESICM/ACCP/ATS/SIS International Sepsis Definitions Conference. Crit Care Med 2003 Vol 31, No.4." This strongly suggests that the ground truth for the training set was established using consensus-based clinical definitions and guidelines for sepsis. It is implied that patient data meeting these established criteria would have been used to train and validate the algorithm.
§ 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).