(90 days)
The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.
The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.
The device does not send any real-time alarms. The device a diagnostic aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.
The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.
The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.
With existing legally marketed vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, weight and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lunq and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.
Vital signs measurement devices integrated in the CareCompanion are FDA approved devices and are used for the same purposes for which they received 510(k) approval. The Patient Station may be configured for use with one to four devices.
The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.
This document describes the CareCompanion Tele Homecare System, which facilitates remote monitoring of patient vital signs. Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics like sensitivity, specificity, accuracy, or correlation coefficients. Instead, it focuses on functional equivalence and passing relevant standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Equivalence | Testing was performed with each vital signs measurement device to show that they operate equivalently when integrated with CareCompanion as when operated as independent devices. The CareCompanion and its predicate systems have the same general use to provide the capability for health care professionals to monitor the vitals signs of some of their patients from remote locations. The main functional differences between the CareCompanion and its predicates (higher resolution images for wound care in predicates, ISDN/DSL/Internet communication in one predicate) are "not significant with regard to performance or safety of the vital signs data monitoring and collection functions." |
| Compliance with Standards | The CareCompanion Patient Station and the CareCompanion Nurse Station have been subjected to performance testing to applicable mechanical, electrical and environmental standards. |
| Safety and Effectiveness | The results of the test indicate that the device is substantially equivalent to its predicate devices and does not raise any new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The testing described is general "functional performance" and "performance testing to applicable mechanical, electrical and environmental standards." It implies integration testing with existing FDA-approved vital signs devices rather than a clinical trial with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for a test set. The focus is on the device's functional performance in relaying data from already approved vital signs devices, rather than on the diagnostic accuracy of the CareCompanion itself based on expert assessment of patient data.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This is consistent with the lack of details on a test set involving human interpretation or clinical data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this document. The device is a "Tele Homecare System," not a diagnostic imaging or interpretation aid that would typically be evaluated with MRMC studies. The primary goal was to demonstrate substantial equivalence for vital signs data transmission, not a direct comparison of human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense, a "standalone" evaluation was part of the testing. The "functional performance" testing confirms that the integrated vital signs measurement devices "operate equivalently when integrated with CareCompanion as when operated as independent devices." This implies testing the CareCompanion's ability to accurately transmit the data generated by the vital signs devices themselves, in a standalone capacity for data transfer, before a human at the Nurse Station interprets it.
7. The Type of Ground Truth Used
The ground truth implicitly used for the functional performance testing of the CareCompanion's data transmission capabilities would be the readings directly provided by the legally marketed and FDA-approved vital signs measurement devices themselves when operated independently. The testing aimed to confirm that the CareCompanion accurately transmits these established readings.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. Given that the device is a data transmission system for pre-existing FDA-approved vital signs monitors, it likely does not involve machine learning or AI models that would require a distinct training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned or implied for machine learning, the establishment of ground truth for a training set is not applicable here. The "ground truth" for the overall system's function comes from the validated outputs of the integrated, standalone vital signs monitors.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).