Search Results
Found 3 results
510(k) Data Aggregation
(322 days)
The BlueStar® CGM insulin dose calculator is software intended for the management of type 1 or type 2 diabetes in persons aged 18 years and older requiring fast-acting insulin. The BlueStar CGM insulin dose calculator allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent CGM glucose reading and rate of change, activity, and, optionally, insulin on board (IOB). The BlueStar CGM insulin dose calculator requires a prescription.
The BlueStar® CGM insulin dose calculator is a software device module existing in the same mobile medical application as BlueStar® Rx (K203434), which is intended for the management of diabetes. When connected to a compatible integrated continuous glucose monitor (iCGM) and under authorization from a qualified healthcare provider, the BlueStar CGM insulin dose calculator allows patients to calculate a dose of bolus insulin for a given amount of carbohydrates, the most recent iCGM glucose reading and its rate of change, activity, and, optionally, insulin on board (IOB). Other patient-specific inputs from BlueStar Rx are used in the calculation of the recommended dose- specifically, duration of insulin to carb ratio, correction factor, and target glucose. In addition to calculating specific dosing recommendations, the BlueStar CGM insulin dose calculator also provides coaching messages to assist the user in maintaining glucose within the target range.
The use of CGM inputs differentiates the BlueStar CGM insulin dose calculator from the insulin dose calculator included in the previously cleared BlueStar Rx, which uses blood glucose (BG) values from a BG meter using a "fingerstick" method. The CGM insulin dose calculator is intended to coexist with the BG insulin calculator function in the BlueStar Rx software application as the BG calculation may be necessary when CGM is unavailable or the CGM estimated blood glucose does not match how the user feels.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, the primary clinical endpoint serves as the de facto acceptance criterion for efficacy, while safety measures address other key concerns.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Efficacy: Mean CGM Time in Range (TIR) when using the BlueStar® CGM insulin dose calculator is not inferior to baseline TIR (percentage of time spent between 70 and 180 mg/dL). | The statistical analysis of the study data showed that the mean TIR when using BlueStar® with the CGM insulin dose calculator is not inferior to the baseline mean TIR prior to using the device. |
| Safety: No increase in time spent in hypoglycemia (glucose below 70 mg/dL). | There was no increase in time spent with glucose below 70 mg/dL. |
| Safety: No increase in time spent in severe hypoglycemia (glucose below 54 mg/dL). | There was no increase in time spent with glucose below 54 mg/dL in the subject populations. |
| Safety: Acceptable adverse events profile, including hypoglycemic events. | Adverse events including hypoglycemic events were recorded. (The document states they were recorded, and the conclusion mentions "These data support the safety of the Bluestar CGM insulin dose calculator," implying an acceptable safety profile, though specific numbers are not provided in this summary.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: 27 adult subjects.
- Data Provenance: The document does not specify the country of origin of the data. The study was prospective as data was "collected for each subject for 30 days while using the BlueStar mobile app with the CGM insulin dose calculator."
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)
The document does not mention the use of experts to establish ground truth for the test set. The ground truth was established by the CGM data itself, as it measured glucose time in range.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any adjudication method for the test set.
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
No, an MRMC comparative effectiveness study was not done. The study focused on the effectiveness of the device (BlueStar® CGM insulin dose calculator) in improving or maintaining Time in Range compared to baseline, rather than comparing human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical study assessed the performance of the "BlueStar mobile app with the CGM insulin dose calculator" as used by the subjects. While patients are "human-in-the-loop" by entering carbohydrates, accepting recommendations, and performing activities, the primary performance metric (TIR) evaluates the algorithm's impact on glucose management, implying a standalone assessment of its functional impact when integrated into patient self-management. The device itself is software that calculates a dose, so the clinical study assesses the impact of these calculations on patient outcomes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used was outcomes data, specifically CGM glucose time in range (TIR) and time spent in hypoglycemia, measured directly from Continuous Glucose Monitoring (CGM) devices.
8. The sample size for the training set
The document does not provide information about a separate training set or its sample size. The clinical study described appears to be a validation study.
9. How the ground truth for the training set was established
Since information about a training set is not provided, how its ground truth was established is also not available in this document.
Ask a specific question about this device
(126 days)
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.
Ask a specific question about this device
(305 days)
The WellDoc BlueStar® System is indicated for use by healthcare providers (HCPs) and their patients - aged 18 years and older - who have type 1 or 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 patients - aged 18 years and older - who have type 1 or 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 patients - aged 18 years and older - who have Type 1 or Type 2 Diabetes. The system is intended to assist Type 1 and Type 2 Diabetes patients to self-manage their disease, as cleared under K162532. 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 licensed HCP with prescribing authority.
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. 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. Data (including blood glucose values, medications, carbohydrates, and activity) entered into these applications are stored in the database and can be retrieved for display in either application. Both applications require the initial web- or mobile-based 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 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. This submission introduces Insulin on Board to be considered in the calculation. The insulin dose calculator is indicated for prescription-use only.
Furthermore, as cleared under K162225, 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. With this application, 3-hour delayed continuous glucose monitoring device data can be accessed via API and uploaded for data visualization purposes only. These modifications do not change the fundamental scientific technology of the device.
This document describes the WellDoc BlueStar and BlueStar Rx System, a software system for diabetes self-management. This 510(k) summary (K190013) references K162532 as the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a table of acceptance criteria with specific performance metrics (e.g., accuracy percentages, error rates). Instead, it states that the device's performance was evaluated through various non-clinical tests to demonstrate substantial equivalence to its predicate.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Software | Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005) for a "Major Level of Concern," and "Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices." Implied acceptance of proper functionality and reliability of the software. | "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 FDA Guidance “Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices”" (No specific performance metrics are given, but compliance with these guidances indicates successful V&V.) |
| Cybersecurity | Evaluation per FDA Guidance Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (October 2, 2014), specifically addressing Identify, Protect, Detect, Response, and Recover areas. Implied acceptance of robust cybersecurity measures. | "Cybersecurity was 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). Specifically, addressing the following areas: Identify and Protect, Detect, Response and Recover" (No specific performance metrics are given, but evaluation against this guidance implies successful implementation of cybersecurity.) |
| Human Factors | Adequate validation of the user interface for use per the labeling for both patients and healthcare providers, ensuring safe and effective interaction for the intended user populations. | "Human factors testing was conducted with the intended user populations of patients and healthcare providers. The human factors, design, and labeling information provided in the submission confirm that the user interface has been adequately validated for use per the labeling." (This indicates successful human factors testing that supports the user interface's validity for its intended use.) |
| Insulin on Board | No new questions of safety or effectiveness are raised by the addition of Insulin on Board (IOB) to the insulin dose calculator function. The linear decay model used must be "well-understood and accepted." | "Both the subject device and reference device use a well-understood and accepted linear decay model to model the Insulin on Board decay. There are no notable differences with regards to this technological characteristic to a previously-cleared device." (This confirms the successful application of the IOB feature without raising new safety/effectiveness concerns, aligning with the implied criteria.) |
| CGM Data Access | No new questions with regards to software or cybersecurity due to the ability to receive 3-hour delayed data from continuous glucose monitoring devices via API for data visualization only. Compliance with special controls stated in 21 CFR 862.1350 (related to CGM secondary display regulation). | "The subject device does not use Bluetooth to connect to a Continuous Glucose Meter directly. There are no new questions with regards to software or cybersecurity. De Novo DEN140038 classified CGM secondary display regulation. BlueStar has complied per the special controls stated in 21 CFR 862.1350." (This indicates successful integration of CGM data access without introducing new software or cybersecurity risks, and compliance with relevant regulations.) |
| Overall Equivalence | The differences between the subject and predicate devices (expanded patient population, IOB, CGM data access) do not raise different questions of safety or effectiveness, and performance data demonstrates substantially equivalent performance to the predicate. | "The differences between the predicate and the subject devices do not raise any new or different questions of safety or effectiveness. The WellDoc® BlueStar® and BlueStar® Rx System is substantially equivalent to WellDoc® BlueStar® and BlueStar® Rx System cleared under K162532 with respect to the indications for use, target populations, treatment method, and technological characteristics." "Performance data provided in the submission, including human factors, design, and labeling information, demonstrate substantially equivalent performance to the predicate." (This is the overarching conclusion of the submission, confirming the device meets the substantial equivalence criteria.) |
2. Sample Sizes used for the Test Set and Data Provenance
The document explicitly states: "Clinical Tests: Not Applicable."
Therefore, there is no test set or information regarding sample sizes, country of origin, or retrospective/prospective nature of data for clinical validation of device performance. The performance claim is based on non-clinical testing and substantial equivalence to a predicate device.
For the Human Factors testing, it mentions: "Human factors testing was conducted with the intended user populations of patients and healthcare providers." However, specific sample sizes for these user populations are not provided. The data provenance is not stated (e.g., country of origin, prospective or retrospective).
3. Number of Experts used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
As there were no clinical tests and no explicit "test set" in the context of clinical performance evaluation (only non-clinical V&V and human factors), there is no information provided about experts establishing ground truth for a test set.
For the human factors study, "healthcare providers" were part of the intended user population, implying experts were involved as participants, but not in establishing ground truth in the traditional sense of diagnostic accuracy. Their qualifications beyond being "healthcare providers" are not detailed.
4. Adjudication Method for the Test Set
Since there was no clinical "test set" requiring ground truth establishment, no adjudication method (e.g., 2+1, 3+1, none) is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document states "Clinical Tests: Not Applicable."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document primarily focuses on the software system's functionality and its ability to process data, provide coaching messages, and calculate insulin doses. The "Software verification and validation" would assess the algorithm's standalone performance in terms of its intended functions. However, there isn't a separate, explicit study titled "standalone performance study" with specific metrics beyond the general software V&V. The human factors testing then evaluates it with human interaction. The insulin dose calculator performs its calculations algorithmically, and its "performance" is implicitly evaluated through software V&V and comparison to a well-understood linear decay model.
7. The type of ground truth used
For the software validation, the "ground truth" would be the expected output of the algorithms and software logic based on design specifications and established clinical models (e.g., for the insulin dose calculator, the "ground truth" is a correct calculation based on inputted parameters and a 'well-understood and accepted linear decay model'). For cybersecurity, the ground truth is adherence to security best practices and robustness against known vulnerabilities. For human factors, the ground truth is the usability and safety of the interface as determined by user interaction and expert review. No pathology or outcomes data is mentioned as ground truth.
8. The sample size for the training set
The document does not mention a training set or its sample size. This is a software medical device, and the evaluation is primarily focused on verification and validation of its deterministic functions, safety, cybersecurity, and human factors, rather than a machine learning model that would require a distinct training set.
9. How the ground truth for the training set was established
Since no training set is mentioned, the method for establishing its ground truth is not applicable.
Ask a specific question about this device
Page 1 of 1