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Health Buddy® with Buddylink is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.

The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (such as blood glucose meter, non-invasive blood pressure cuff and patient weight scale). The Health Buddy with Buddylink retrieves data from a medical device (blood glucose meter, non-invasive blood pressure cuff, or patient weight scale) and stores it for later transmission to a healthcare provider. The device has a data port that allows it to download readings from the attached device, only activated upon appropriate patient enrollment.

The Health Buddy with Buddylink is a simple; user-friendly device that connects to the patient's standard home telephone line. The device connects to the Data Center via a toll-free number to send responses from the previous day and to retrieve the current day's dialogue.

The screen displays the information or questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient information is sent to the patient's health care provider.

This device, the Health Buddy® with Buddylink, is a communication product that connects to a telephone line. It is used by patients to answer questions and furnish information to their healthcare professional(s) between office visits. It can retrieve data from an attached medical device (blood glucose meter, non-invasive blood pressure cuff, or patient weight scale) and stores it for later transmission to a healthcare provider.

Based on the provided information, the submission focuses on a modification to the software in the Health Buddy® with Buddylink, not a new stand-alone study to prove effectiveness against specific acceptance criteria. The device is cleared based on substantial equivalence to predicate devices. Therefore, the traditional acceptance criteria and detailed study results, as one might expect for a de novo device, are not explicitly provided in this document.

Here's an attempt to answer your questions based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a modification to software and relies on substantial equivalence, explicit "acceptance criteria" and "reported device performance" in the quantifiable sense of a clinical trial are not presented. The primary "acceptance criterion" met here is demonstrating substantial equivalence to legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

No specific test set or sample size for a performance study is described as this is a substantial equivalence submission for a software modification. The comparison is against predicate devices.

• Sample Size for Test Set: Not applicable / Not provided.
• Data Provenance: Not applicable / Not provided for an independent performance study. The comparison is based on the characteristics and cleared status of the predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. As no independent test set performance data is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable. No discrete test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done or described in this document. The submission is based on substantial equivalence to predicate devices, not improvement over human readers or AI assistance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study is not described. The device is a communication tool, and its function involves human input (data from medical devices, patient responses) and human interaction (healthcare providers receiving data). The evaluation focused on its equivalence as a communication tool.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic or interpretive performance. The "ground truth" for the device's function is its ability to reliably collect and transmit data, which is implicitly accepted through the substantial equivalence argument to already cleared devices.

8. The Sample Size for the Training Set

Not applicable. This document describes a medical device (hardware with software), not a machine learning algorithm requiring a training set for model development in the sense of AI performance evaluation. The software modification is likely related to connectivity or user interface enhancements rather than a learning algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set for a machine learning model is mentioned.

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