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BlueStar® Rx is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar Rx is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar Rx automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar Rx analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar Rx provides coaching messages (motivational, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

• For bolus insulin users with type 2 diabetes, BlueStar Rx includes an insulin dose calculator to allow patients to use their prescribed regimen to calculate a dose of bolus insultin for a given amount of carbohydrates and/or glucose value.

· For basal insulin users with type 2 diabetes, BlueStar Rx includes an Insulin Adjustment Program (IAP) which calculates appropriate long-acting basal insulin levels based on configuration by a healthcare provider. The healthcare provider must activate the IAP and configure it for patient-specific parameters.

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

BlueStar® is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to provide secure capture, storage, and transmission of glucose data as well as information to aid in diabetes self-management. BlueStar automatically receives insulin dose related data when connected to compatible Tempo Smart Button™ device via wireless Bluetooth® technology and has the ability to detect and mark which doses are prime and which are injected insulin. BlueStar analyzes and reports glucose test results and supports medication adherence. In addition, BlueStar provides coaching messages (motivational, behavioral, and educational) based on real-time glucose values and trends. It includes software intended for patient use on mobile phones and software intended for healthcare provider use through computer web browsers. The software also allows for entry of other diabetes-related healthcare information and provides educational information.

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

BlueStar® (subject device) combines the existing diabetes self-management features of the predicate (BlueStar® and BlueStar® Rx, K193654) with the automatic tracking of insulin delivery functionality of the reference InPen System (K160629). BlueStar maintains all of the features of the predicate and adds the capability to connect with compatible devices connected with insulin pens via Bluetooth wireless technology. In this submission, the predicate device is being modified such that it can receive insulin dose-related data when connected to a Tempo Smart Button™ (TSB). The TSB when attached to a disposable Tempo Pen (insulin pen), can transfer dose-related data (corresponding to the brand of insulin, dose amount, date, and time) via Bluetooth® Low Energy (Bluetooth) wireless technology.

BlueStar is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. BlueStar is intended to assist patients in managing their diabetes with guidance from their providers. BlueStar has two versions – BlueStar (Over the Counter, OTC) and BlueStar Rx (prescription use version).

BlueStar is comprised of the following software applications (app):

• iOS and Android based mobile apps for patients .
• web-based app (web-portal) for HCPs ●

BlueStar requires initial registration before the patient can access the software applications.

BlueStar is compatible with devices including Blood Glucose Meters (BGM), Blood Pressure Monitors, Continuous Glucose Monitors (CGM) , Tempo Smart Button™ 2, Weight Scales, Activity Trackers. Data, including blood glucose values, blood pressure, medications, carbohydrates, physical activity, weight, and sleep are entered, stored and processed in the patient software applications. Data can be entered manually or automatically via Bluetooth for compatible devices. Additionally, the mobile application for patients is capable of automatically receiving, storing, processing, and displaying insulin data from the Tempo Smart Button via Bluetooth.

The BlueStar apps for patients function as an information repository (logbook and Personal Health Record) and diabetes education resource (curriculum, articles, videos). Patients also receive in-the-moment coaching (Real Time Feedback messages), Pattern Reports and SMART Visit Reports that can be shared with their providers. Coaching messages are motivational, behavioral, and educational in nature and are based on data (and trends) including real-time blood glucose, blood pressure, and weight. Patients receive guidance on diabetes selfmanagement and are encouraged to reach out to their healthcare team when needed. Patients also receive insights based on data entered and trends detected by the app. BlueStar patient apps include a secure communication system (Message Center) as well as a medication information repository (dose and schedule). Qualified type 1 and type 2 diabetes patients have access to a bolus insulin calculator (cleared under K190013). Qualified type 2 diabetes patients have access to the Insulin Adjustment Program (IAP) to titrate long-acting basal insulin (cleared under K193654). Patients use their mobile software applications to follow their HCP's bolus insulin prescription or basal insulin titration plan. The bolus insulin calculator and basal insulin titration features are only available in BlueStar Rx for use under the direction of their HCP.

The provider can review patient information, workflows and decision support information using the web-based software application for HCP. The HCP can initiate and manage basal insulin titration (IAP) and the bolus insulin calculator prescription / parameters through the web-based software application for HCP.

The SMART Visit Report includes data summary, analysis, and decision support for treatment as well as psychosocial issues identified by patient survey responses within the app. The SMART Visit Report can be sent by the patient to his/her HCP from the mobile app. The HCP can also generate SMART Visit Reports from their web portal.

The provided text is a 510(k) summary for the Welldoc BlueStar® and BlueStar® Rx devices. It details the device description, indications for use, comparison to predicate devices, and performance testing. However, it explicitly states "Not Applicable" under "Clinical Tests," indicating that the submission did not include a clinical study to prove the device meets specific acceptance criteria based on human subject data.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This would typically come from a clinical study with predefined endpoints and success metrics.
• Sample size used for the test set and the data provenance: Clinical test sets were not used.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as a clinical test set with ground truth established by experts was not described.
• Adjudication method for the test set: Not applicable.
• 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: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable for a clinical study context. The performance testing section mentions "Software verification and validation," which would assess the algorithm's functionality, but not in the format of a standalone clinical performance study to meet specific acceptance criteria.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as there was no explicit clinical study described to establish ground truth for a test set.
• The sample size for the training set: The document briefly states that the device integrates existing features and technologies, implying the underlying algorithms (like the insulin dose calculator or IAP) were previously validated, but it does not specify a training set size for the current device's development.
• How the ground truth for the training set was established: Not described.

Summary of what the document does provide regarding "performance criteria" and "proof":

The acceptance criteria and proof of performance for this 510(k) submission are based on bench testing and software verification/validation, rather than a clinical study with human patients and explicitly defined performance metrics in the way you've outlined.

The document indicates the following performance testing was performed to support substantial equivalence:

• Software verification and validation: Per the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a Major Level of Concern. This means the software was tested to ensure it functions as designed and meets its specifications.
• Cybersecurity: Evaluated per the FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff (October 2, 2014).
• Human Factors: Evaluation conducted with intended user populations (patients and healthcare providers). The human factors information confirms the user interface was adequately validated per labeling.

The conclusion states: "Performance testing demonstrated that the BlueStar Rx performed as intended. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness."

In essence, the "acceptance criteria" appear to be met by demonstrating the device's functional integrity, cybersecurity, and usability through these non-clinical tests, and by showing substantial equivalence to a previously cleared predicate device, rather than by a de novo clinical study with quantitative performance metrics against a defined ground truth.

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