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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.

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The Optum TeleHealth Application is a software application designed to retrospectively monitor vital signs. The following vital signs are collected: noninvasive blood pressure, pulse oximetry, 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 two configurations:

• stand-alone application .
• 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 tablets (Android OS 4.0 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 .

• 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, as listed below:

• 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 Optum TeleHealth Application is a software application designed to collect, display, and transmit patient vital signs and physiological data for review and analysis by clinicians. The device is not intended for emergency use or real-time monitoring.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

The document does not specify a distinct "test set" in the context of a clinical study with patients. The testing performed was "Bench testing, including software validation." This typically involves internal testing by developers rather than a separate patient-based test set for performance evaluation. Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the testing described is limited to "bench testing" and "software validation," not a clinical study requiring expert-established ground truth.

4. Adjudication method for the test set

This information is not applicable as the testing described is limited to "bench testing" and "software validation," not a clinical study requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a data collection and transmission application, not an AI-powered diagnostic tool requiring human reader interpretation improvements.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device itself is a standalone software application in the sense that it operates independently to collect and transmit data. However, its intended use inherently involves a "human-in-the-loop" (clinicians reviewing and analyzing the data). No study focused on "algorithm only without human-in-the-loop performance" was explicitly mentioned, other than software validation.

7. The type of ground truth used

For the "bench testing" and "software validation," the ground truth would likely be established through predefined software requirements, expected output values for simulated inputs, and adherence to communication protocols. It would not typically involve expert consensus, pathology, or outcomes data in the way a diagnostic device would.

8. The sample size for the training set

The document does not mention a "training set." This type of testing is characteristic of traditional software validation, not machine learning model training as understood in current AI contexts.

9. How the ground truth for the training set was established

Not applicable, as no training set for a machine learning model was identified. The device's validation relied on traditional software testing methodologies.

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