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The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The BlueStar System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

The BlueStar® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

The WellDoc BlueStar® Rx System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older - who have type 2 diabetes. The BlueStar Rx System is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. The BlueStar® Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the BlueStar Rx System provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information. BlueStar® Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value.

The BlueStar® Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

WellDoc® BlueStar® is a stand-alone software system intended to be used by healthcare providers (HCPs) and their adult patients – aged 21 years and older - who have Type 2 Diabetes. The system is intended to assist Type 2 Diabetes patients to self-manage their disease, as cleared under K100066. Patients receive guidance on diabetes self-management and are encouraged to reach out to their healthcare team when needed. There are two versions of BlueStar® -BlueStar® and BlueStar® Rx - which differ in the availability of the insulin dose calculator, which is restricted to a prescription from a HCP.

BlueStar® and BlueStar® Rx are implemented through an enterprise such as a health plan or large physician group in tandem with a patient's healthcare team and are comprised of the following applications:

• Enterprise Director Portal
• HCP Service
• Patient Mobile Application
• Patient Web Portal

The Enterprise Director application is used for administrative purposes (unchanged since cleared under K100066). The HCP Service houses the Medication Reconciliation feature, which allows for the process of identifying the most accurate list of all medications that the patient is taking, including name, dosage and frequency, by comparing the medical record to an external list of medications obtained from a patient, hospital, or other provider (cleared under K141273).

The Patient Web Portal and the Patient Mobile application have a similar feature set (unchanged since cleared under K100066). Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications is stored in the database and can be retrieved for display in either applications require the initial web- or mobilebased registration before the patient can access them. On the patient applications (Mobile and Web), BlueStar® and BlueStar® Rx function as an (1) information repository (logbook and Personal Health Record) and (2) diabetes education resource (learning library and health tips) and provide (3) motivational, behavioral, and educational coaching based on real-time blood glucose values and trends, (4) a secure communication system (Message Center), (5) medication information (dose and schedule), and (6) workflow and decision support for healthcare providers.

In BlueStar® Rx, the patient web portal and mobile application also provide an insulin dosing calculator to allow patients to use their prescribed regimen to calculate a dose of insulin for a given amount of carbohydrates and/or blood glucose value. The insulin dose calculator is restricted to prescription-use only.

Furthermore, as cleared under K16225 (reference device), BlueStar® and BlueStar® Rx have the ability to connect to the One Touch Verio Flex Blood Glucose Meter (K150214) via Bluetooth. This will allow users to send data from their meter to the BlueStar® Rx app, which will provide coaching messages (motivational, behavioral, and educational) based on the real-time blood glucose values and trends. The BlueStar Server will also have the ability to transmit data to the OneTouch Reveal Server. These modifications do not change the fundamental scientific technology of the device.

The provided documentation is a 510(k) summary for the WellDoc BlueStar® and BlueStar® Rx systems. It describes the device, its indications for use, and a comparison to predicate devices, but does not appear to contain detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria.

Instead, the document primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices (K100066 and K162225) based on intended use, design, materials, and overall performance characteristics. The "Non-Clinical Performance Data" section mentions "Software Verification, Software Validation, Human Factors Testing" as data provided to support substantial equivalence, suggesting these activities were performed. However, it does not provide the specific acceptance criteria for these tests or the detailed results that would allow for a table of acceptance criteria versus reported device performance.

Therefore, many of the requested fields cannot be filled directly from this document.

Here's a breakdown based on the information available:

1. Table of acceptance criteria and the reported device performance

Information Not Available in Document: The document does not provide a specific table of acceptance criteria or quantifiable performance metrics beyond stating that "Verification, validation and human factors testing showed that the system can be used by a layperson without HCP oversight, meets its requirements and functions as intended." It does not list target accuracy, specificity, sensitivity, or other predefined benchmarks with corresponding measured values.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Information Not Available in Document: The document does not specify the sample size used for the mentioned "Software Verification, Software Validation, Human Factors Testing" or the provenance of any data used in these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Information Not Available in Document: The document does not mention the use of experts to establish ground truth for any test set. The focus is on software functionality and human factors for a self-management diabetes system, not diagnostic accuracy requiring expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Information Not Available in Document: The document does not describe any adjudication methods, as no expert-based ground truth establishment is mentioned.

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

Information Not Available in Document: An MRMC comparative effectiveness study is not mentioned. The device, an AI-powered diabetes self-management system, isn't described in a way that suggests "human readers" or "AI assistance" in the context of image interpretation or similar diagnostic tasks. Its function is to provide coaching messages and an insulin dose calculator.

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

Information Available:
The device ("WellDoc BlueStar®" and "WellDoc BlueStar® Rx") is a "stand-alone software system" intended for use by both patients and healthcare providers. The document states that "software intended for use on mobile phones or personal computers" and that the system "provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends." BlueStar® Rx also "includes an insulin dose calculator." These descriptions imply standalone algorithm performance in generating coaching messages and calculating insulin doses based on input data. The "human factors testing" mentioned confirms that the system is designed to be used by a layperson, indicating that the core functionality operates somewhat independently, though the system is meant to support self-management with HCP oversight (for Rx version).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Information Not Available in Document: The document does not specify the type of ground truth used for any testing. Given the nature of the device (diabetes management, coaching, insulin calculation), "ground truth" would likely relate to the correctness of calculations or the appropriateness of coaching messages, which might be assessed against clinical guidelines or pre-defined rules rather than expert consensus on medical images or pathology.

8. The sample size for the training set

Information Not Available in Document: The document does not provide any information about a training set size or methodology. It's unclear if machine learning/AI techniques that require explicit training sets were used in a manner that necessitated reporting such a detail in this K162532 summary, as the "AI" aspect is described more generally as providing "coaching messages... based on real-time blood glucose values and trends."

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

Information Not Available in Document: As no training set is mentioned, the method for establishing its ground truth is also not provided.

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