(118 days)
The Intel-GE Care Innovations Guide is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.
The Intel-GE Care Innovations Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational content to patients.
The Intel-GE Care Innovations Guide is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.
The Intel-GE Care Innovations Guide is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
The Intel-GE Care Innovations Guide is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. The Intel-GE Care Innovations Guide is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless or tethered medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC. Intel-GE Care Innovations Guide also stores the information remotely on a host server, where the caregiver can view the measurement via the host server once synchronization between the host server and Intel® Health Guide Express has been completed. Intel-GE Care Innovations Guide can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing.
The Intel-GE Care Innovations Guide is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered. The Intel-GE Care Innovations Guide system consists of the:
Intel-GE Care Innovations Guide software application: (1)
The software application captures, stores, displays and transmits information to a secure database on a host server running the Intel-GE Care Innovations Health Care Management Suite software via a standard telephone line or internet connection. The Intel-GE Care Innovations Guide software runs on a Commercial Off The Shelf (COTS) Personal Computer (PC).
Intel-GE Care Innovations Health Care Management Suite software application: (2)
The software application runs on a host server and allows caregivers to review patient vital signs on the secure website. The Intel-GE Care Innovations Health Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.
The provided text describes a 510(k) submission for a modification to the Intel-GE Care Innovations Guide, a remote patient monitoring system. However, the document explicitly states that "The Intel-GE Care Innovations Guide does not rely on an assessment of clinical performance data."
Therefore, it is not possible to describe acceptance criteria or a study that proves the device meets those criteria, as such information is not present in the provided text.
Specifically, the document states:
"The Intel-GE Care Innovations Guide does not rely on an assessment of clinical performance data. The device conforms to FDA's recognized consensus standards and relies on its conformity to demonstrate the safety and efficacy. The device introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate device."
This means the submission for this device did not include a clinical study with acceptance criteria to demonstrate performance. Instead, it relied on conformity to recognized standards and substantial equivalence to a predicate device (Intel-GE Care Innovations Guide, K103276).
Since there is no performance study described, all sections of your request related to study details (acceptance criteria table, sample sizes, experts, adjudication, MRMC, standalone performance, ground truth, training set) cannot be fulfilled from the provided text.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).