Search Results

The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse rate, weight, temperature, and blood glucose. The Optum TeleHealth Application collects, displays, and transmits vital sign measurements captured from commercially available FDA cleared medical devices designed for home use, or via manual input by the patient. Collected measurement data from the Optum TeleHealth Application can be transmitted via a secure communication mechanism to a central health data repository. Data can be viewed and analyzed via the Optum TeleHealth Web Application.

The Optum TeleHealth Application is not intended for emergency use or real-time monitoring.

The client application is available in three configurations:

• stand-alone application for both Android and iOS operating systems
• pre-loaded on an Android tablet

The Optum TeleHealth Application is client/server software application which collects and transmits patient vital signs, and physiological data for review, and analysis by clinicians. The software consists of a web based application for clinician use, the client application for member use, and web services. Standard data communication protocols are used. The server hosts the web based application for user management, and patient information and care management. The client application is designed to work with Android devices (OS 4.0 and higher) and Apple devices (iOS 9 and higher), and allows for data input from external biometric measuring devices, review of clinician advice, response to clinician questions, and viewing of graphed data.

The client application is available in two configurations:

• stand-alone application for both Android and iOS operating systems .
• . pre-loaded on an Android tablet

The device is used in combination with various Class I 510(k) exempt devices and FDA cleared biometric measuring devices, including, but not limited to:

• A&D Medical, UA-767PBT Digital Blood Pressure Monitor (K043217) .
• . A&D Engineering Inc., UC-321PBT Weight Scale (510(k) exempt)
• TaiDoc Technology Corporation, Fora W310 Weight Scale (510(k) exempt) .
• . TaiDoc Technology Corporation, Fora IR20b Ear Thermometer (K090395)
• TaiDoc Technology Corporation, Fora P20 Blood Pressure Monitor (K092106) ●
• Nonin Medical Inc Onyx II Model 9560 Finger Pulse Oximeter (K081285) ●

The provided document is a 510(k) premarket notification letter and summary for the Optum TeleHealth Application. It describes a software application designed to collect, display, and transmit vital sign measurements for retrospective monitoring. As such, it is a data handling and transmission device, not a diagnostic or prognostic medical imaging AI device.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving device performance as typically expected for a medical imaging AI device. Specifically, it does not include:

• A table of acceptance criteria with reported device performance (e.g., sensitivity, specificity, AUC).
• Details on sample size, data provenance, ground truth establishment, or expert involvement for a test set designed to evaluate diagnostic or prognostic performance.
• Information on MRMC studies or standalone algorithm performance.

Instead, the document focuses on:

• Indications for Use: Retrospective monitoring of vital signs (noninvasive blood pressure, pulse rate, weight, temperature, blood glucose). It explicitly states it's not intended for emergency use or real-time monitoring.
• Technological Characteristics: How it collects data (manual input, Bluetooth from external devices) and transmits it to a central repository.
• Predicate Devices: Claiming substantial equivalence to a previously cleared Optum TeleHealth Application (K130971).
• Pre-Clinical Testing: A generic statement that "Bench testing, including software validation, was performed to ensure that the product works as intended." and "Results of bench testing show that the product is safe, and effective for use." This implies functional verification and validation of the software, rather than clinical performance evaluation against a diagnostic ground truth.

In summary, this device's function is data aggregation and transmission, not medical image analysis or diagnosis. The typical performance metrics and study designs (like MRMC, standalone performance, or detailed ground truth establishment for diagnostic accuracy) are not applicable or described for this type of device in the provided document.

Ask a specific question about this device