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510(k) Data Aggregation
(305 days)
WellDoc BlueStar
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.
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(125 days)
WellDoc BlueStar, WellDoc BlueStar Rx
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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(106 days)
WellDoc BlueStar (WellDoc DiabetesManager System and DiabetesManager-Rx System
DiabetesManager® (OTC Use): The WellDoc DiabetesManager® System is indicated for use by healthcare providers (HCPs) and their adult patients - aged 21 years and older -who have type 2 diabetesManager® 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 DiabetesManager® System analyzes and reports blood glucose test results and supports medication adherence. 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 DiabetesManager® System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
DiabetesManager®-Rx (Prescription Use): The WellDoc DiabetesManager®-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 DiabetesManager®-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 DiabetesManager®-Rx System analyzes and reports blood glucose test results and supports medication adherence. In addition, the DiabetesManager®-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.
The DiabetesManager®-Rx System is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.
The WellDoc BlueStar DiabetesManager® System is a stand-alone, over-the-counter (OTC) software system that has the capability of providing additional functions, if and when, the functions are prescribed by the prescribing healthcare provider. Once the additional prescription (Rx) functions are activated, the entire software system is called WellDoc BlueStar DiabetesManager-Rx® System.
Both BlueStar DiabetesManager System and DiabetesManager-Rx System are implemented through an enterprise such as a health plan or large physician group in tandem with healthcare providers (HCPs) 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 (changed under K141273), 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.
The Patient Web Portal and the Patient Mobile application have a similar feature set. Data entered into these applications is 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. Patientified by healthcare providers and an access code is provided to allow access to both the web and mobile applications. On the patient applications (Mobile and Web), the basic DiabetesManager System functions as an information repository [logbook and Personal Health Record (PHR)], diabetes education resource (learning library and health tips), educational messaging/coaching, and secure communication system (Message Center). If and when a prescription is obtained, additional functions become available to the patient as DiabetesManager-Rx System. Prescription functions include additional medication information (dose and schedule), enhanced coaching [(Blood Glucose (BG) real-time coaching feedback), messaging (Message Center Content), and workflow and decision support for healthcare providers. 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.
With this 510(k), BlueStar will have FDA clearance 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 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 or the indications for use of the device.
The provided document is a 510(k) summary for the WellDoc BlueStar (WellDoc DiabetesManager® System and DiabetesManager®-Rx System). It primarily addresses administrative changes and modifications to the device's connectivity, rather than a comprehensive clinical study proving efficacy against specific acceptance criteria for the core functionality.
However, based on the non-clinical performance data section, we can infer the acceptance criteria and the study that proves the device meets them, specifically for the modifications introduced with this 510(k).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a formal table with quantitative acceptance criteria and their corresponding performance metrics. Instead, it mentions that "Verification, validation and human factors testing were performed to ensure that the device meets its requirements and intended use." For the specific modifications, the performance is reported qualitatively.
| Acceptance Criterion (Inferred from Modifications) | Reported Device Performance (Qualitative) |
|---|---|
| Successful data transmission from OneTouch Verio Flex BG meter to BlueStar app | "data was transmitted successfully from the OneTouch Verio Flex BG meter" |
| Successful data transmission from BlueStar Server to OneTouch Reveal Server | "data was transmitted successfully... to the One Touch Reveal Server" |
| Compatibility of the app with specified mobile environmental operating systems (iOS 9.X+, Android 4.3+) | "the app is compatible with the mobile environmental operating systems" |
| Overall system functions as intended after modifications | "the system functions as intended" |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Verification, validation and human factors testing were performed." However, it does not specify the sample size used for these tests (e.g., number of users, number of data transmissions, number of test cases).
The data provenance is not explicitly mentioned but would typically be from laboratory testing and potentially simulated or real-world user testing during the verification and validation phases. Given the nature of a software and connectivity update, the testing would likely be prospective, conducted by the manufacturer. The country of origin for the data is not stated, but the manufacturer is based in Columbia, Maryland, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not mention the use of external experts to establish ground truth for the technical performance tests described. These tests would typically involve engineers and quality assurance personnel verifying system functionality against defined specifications. If "human factors testing" involved experts, their number and qualifications are not specified.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. For technical verification and validation, success or failure is usually determined by predefined criteria in test protocols, rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document describes modifications related to connectivity and data transmission, not a new diagnostic or interpretative algorithm that would typically warrant an MRMC study comparing human readers with and without AI assistance. The changes "do not change the fundamental scientific technology or the indications for use of the device," implying the core functionality and interpretations remain as previously cleared.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done
The described tests are primarily standalone evaluations of the updated software's technical functionality, specifically its ability to connect and transmit data. The "system functions as intended" implies an assessment of the algorithm and data flow without necessarily involving a human actively interpreting its output in a clinical decision-making context during these specific tests. However, it's not a standalone study of a new algorithm's diagnostic or predictive performance.
7. The Type of Ground Truth Used
For the connectivity and compatibility tests, the ground truth would be based on:
- Technical specifications and expected operational behavior: Verifying that data packets are correctly transmitted and received, and that the application functions on specified operating systems as per its design.
- Known device outputs/inputs: For data transmission, the ground truth would be the actual blood glucose values from the OneTouch Verio Flex BG meter, verifiable against the data received by the BlueStar app and transmitted to the OneTouch Reveal Server.
8. The Sample Size for the Training Set
The document does not mention a training set because the modifications described are related to connectivity and compatibility, not the development or retraining of a machine learning algorithm. The core algorithms for "coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends" are presumed to be part of the previously cleared device (K100066) and are not being newly developed or revised in a way that would require a new training set in this submission.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned for the modifications in this submission, the acquisition of ground truth for a training set is not applicable here.
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