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510(k) Data Aggregation
(119 days)
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The SmartBolus Calculator is software intended for the management of diabetes in persons aged 2 and older requiring rapid-acting U-100 insulin. The SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The SmartBolus Calculator is intended for single patient, home use and requires a prescription.
The SmartBolus Calculator is a software device that is a component of the Omnipod 5 Automated Insulin Delivery System. The SmartBolus Calculator exists on the Omnipod 5 App portion of the Omnipod 5 ACE Pump and relies on the user interface of the App.
The SmartBolus Calculator receives input parameters and settings from other components of the system and calculates a suggested bolus amount of insulin to correct an elevated glucose level (a correction bolus) and/or to cover carbohydrates from a meal (meal bolus). The SmartBolus Calculator allows users to have the option of populating the current estimated glucose value and trend, which is communicated by the connected iCGM. Users may also manually enter the estimated glucose value or a blood glucose (BG) reading from a blood glucose meter. In addition to glucose, the suggested bolus dose is calculated based on the following parameters: user-entered carbohydrates, rate of change of the sensors qlucose (if using a CGM), correction factor, insulin to carbohydrate ratio, target glucose value, and insulin on board (IOB). Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling.
The SmartBolus Calculator can be used in the Omnipod 5 Automated Insulin Delivery System with both Manual Mode and Automated Mode.
Here's a summary of the acceptance criteria and study information for the SmartBolus Calculator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly list specific acceptance criteria in a quantitative manner for the SmartBolus Calculator's performance. Instead, it states that:
- "Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the device is safe for use."
- "Through performance testing, the Subject device has been shown to meet the Special Controls and determined to be substantially equivalent to its predicate."
- "There was no impact to clinical performance of the SmartBolus Calculator for the design change discussed in this submission."
This implies that the assessment for this 510(k) submission focused on demonstrating that the new iOS version of the SmartBolus Calculator (subject device) performs identically to the predicate Android version (K222239) and meets the same safety and effectiveness standards, rather than establishing new performance metrics.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a test set in the context of clinical or performance data for the SmartBolus Calculator itself. The testing mentioned is primarily "software verification and validation testing" and "risk management" activities.
The data provenance is also not explicitly stated as retrospective or prospective clinical data. The testing described appears to be internal software development and validation, rather than a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The testing described is software-centric, and there's no mention of expert-established ground truth for a test set in a medical diagnostic sense.
4. Adjudication method for the test set
This information is not provided in the document, as it doesn't describe a clinical test set requiring adjudication.
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
An MRMC comparative effectiveness study was not mentioned or described. The device is an "Insulin Therapy Adjustment Device," not a diagnostic imaging device where MRMC studies are typically conducted. The document focuses on demonstrating substantial equivalence of a new software implementation (iOS) to an existing one (Android).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The SmartBolus Calculator is described as an "Algorithmic software device." Its function is to "calculate a suggested bolus dose." However, it operates as a component of the Omnipod 5 App, and "Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling." This indicates it's a human-in-the-loop system, where the user has ultimate control and decision-making power over the suggested dose. Therefore, a purely standalone clinical performance evaluation without human decision-making is not explicitly implied or discussed in this context. The software's calculation itself is standalone, but its application involves a human.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not specify a type of ground truth related to clinical outcomes or expert consensus for its performance evaluation for this particular submission. The "verification activities" and "software verification and validation testing" likely used predefined software requirements, simulated data, and mathematical correctness of calculations as their "ground truth" to ensure the algorithms produced the expected outputs given specific inputs according to the established insulin calculation formulas.
8. The sample size for the training set
The document does not describe a training set in the context of machine learning. The SmartBolus Calculator is an algorithm that computes a bolus dose based on programmable factors and user inputs, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
As there's no mention of a machine learning model or a training set, this information is not applicable.
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(322 days)
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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.
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(24 days)
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The SmartBolus Calculator is software intended for the management of diabetes in persons aged 2 and older requiring rapid-acting U-100 insulin. The SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose value (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The SmartBolus Calculator is intended for single patient, home use and requires a prescription.
The SmartBolus Calculator is a software device that is a component of the Omnipod 5 Automated Insulin Delivery System. The SmartBolus Calculator exists on the Omnipod 5 App portion of the Omnipod 5 ACE Pump and relies on the user interface of the App. The SmartBolus Calculator receives input parameters and settings from the other components of the system and calculates a suggested bolus amount of insulin to correct an elevated glucose level (a correction bolus) and/or to cover carbohydrates from a meal (meal bolus). The SmartBolus Calculator allows users to have the option of populating the current estimated glucose value and trend, which is communicated by the connected iCGM. Users may also manually enter the estimated glucose value or a blood glucose (BG) reading from a blood glucose meter. In addition to glucose, the suggested bolus dose is calculated based on the following parameters: user-entered carbohydrates, rate of change of the sensor glucose (if using a CGM), correction factor, insulin to carbohydrate ratio, target qlucose value, and insulin on board (IOB). Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling. The SmartBolus Calculator can be used in the Omnipod 5 Automated Insulin Delivery System with both Manual Mode and Automated Mode.
The information provided focuses on the substantial equivalence of the SmartBolus Calculator to a predicate device, specifically regarding the expansion of its age range of intended users. The document details the clinical study performed to support this expanded indication, rather than a general acceptance criteria study for the device's core functionality.
Here's an analysis of the provided information based on your requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria in a tabular format for the SmartBolus Calculator's overall performance. Instead, the "acceptance criteria" can be inferred from the clinical study's primary objective, which was to evaluate safety based on glucose metrics. The study aimed to show that the use of the SmartBolus Calculator in the expanded age group (2.0-5.9 years) did not significantly worsen these safety metrics compared to manual entry of blood glucose values.
| Acceptance Criteria (Inferred from Study Objective) | Reported Device Performance |
|---|---|
| Safety Metrics (4-hour post bolus period): | |
| Mean % time Blood Glucose 180 mg/dL (Phase 2 vs Phase 1) | Mean decrease of 2.03% in Phase 2 (33.2%) vs. Phase 1 (35.2%). (P = 1.0000, not statistically significant) |
| Number of deaths | 0 |
| Number of serious adverse events | 0 |
| Number of unanticipated adverse device effects (UADE) | 0 |
| Number of non-serious adverse events | 1 (prolonged hyperglycemia) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 5 subjects in the preschool cohort (aged 2.0-5.9 years).
- Data Provenance: The study was a "single-arm, multi-center, prospective clinical study" conducted across "2 US clinical sites." Therefore, the data is prospective and from the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not provide details on the number or qualifications of experts used to establish ground truth for the test set. The clinical study collected glucose metrics directly from the subjects, which served as the primary data for evaluation.
4. Adjudication Method for the Test Set
The document does not mention an explicit adjudication method for the clinical study's data. Clinical study data, particularly objective metrics like blood glucose levels, typically do not require adjudication in the same way imaging or subjective diagnostic interpretations might. Safety events would be reviewed by the study investigators and reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study was a clinical trial evaluating the safety and effectiveness of the device in a specific patient population, not a comparative study of human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This study was a human-in-the-loop study. The SmartBolus Calculator is a software device that recommends a bolus dose, but the user "has the option of delivering the suggested dose of insulin, modifying the amount, or canceling." The clinical study evaluated the device's performance when used by patients/caregivers in Manual Mode.
7. The Type of Ground Truth Used
The ground truth for the clinical study was based on objective clinical outcomes data (glucose metrics and adverse events) directly measured from the study participants during the two phases of the study (Manual Mode with manual BG entry vs. Manual Mode with SmartBolus Calculator use).
8. The Sample Size for the Training Set
The document does not provide information on the sample size for the training set used to develop the SmartBolus Calculator. The submission focuses on the clinical validation of the device's expanded indication, not its initial development.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established.
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(400 days)
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The Omnipod 5 SmartBolus Calculator is software intended for the management of diabetes in persons aged 6 and older requiring rapid-acting U-100 insulin. The Omnipod 5 SmartBolus Calculator calculates a suggested bolus dose based on user-entered carbohydrates, most recent sensor glucose reading (or blood glucose reading if using fingerstick), rate of change of the sensor glucose (if applicable), insulin on board (IOB), and programmable correction factor, insulin to carbohydrate ratio, and target glucose value. The Omnipod 5 SmartBolus Calculator is intended for single patient, home use and requires a prescription.
The Omnipod 5 SmartBolus Calculator is a software device that is a component of the Omnipod 5 Automated Insulin Delivery System. The SmartBolus Calculator exists on the Omnipod 5 App portion of the Omnipod 5 ACE Pump and relies on the user interface of the App.
The Omnipod 5 SmartBolus Calculator receives input parameters and settings from the other components of the system and calculates a suggested bolus amount of insulin to correct an elevated glucose level (a correction bolus) and/or to cover carbohydrates from a meal (meal bolus). The Omnipod 5 SmartBolus Calculator allows users to have the option of populating the current estimated glucose value and trend, which is communicated by the connected iCGM. Users may also manually enter the estimated glucose value or a blood glucose (BG) reading from a blood glucose meter. In addition to glucose, the suggested bolus dose is calculated based on the following parameters: user-entered carbohydrates, rate of change of the sensor glucose (if using a CGM), correction factor, insulin to carbohydrate ratio, target glucose value, and insulin on board (IOB). Once the calculation is complete, the user has the option of delivering the suggested dose of insulin, modifying the amount, or canceling.
The Omnipod 5 SmartBolus Calculator can be used in the Omnipod 5 Automated Insulin Delivery System with both Manual Mode and Automated Mode. When the Omnipod 5 SmartBolus Calculator is used with manually-entered BG readings, it suggests a bolus dose based on the same calculations as the currently cleared Omnipod DASH Insulin Management System (K180045, most recently cleared in K192659).
The document describes the Omnipod 5 SmartBolus Calculator, a software device for diabetes management. Here's a breakdown of the acceptance criteria and the study proving it meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the statement that the device meets "Insulin Therapy Adjustment Device special controls and to be safe and effective." The clinical study focused on glycemic control within 4 hours of bolusing. While explicit acceptance criteria for these percentages are not given as strict pass/fail thresholds, the performance observed is presented as evidence of safety and effectiveness, particularly regarding hypoglycemia.
| Glycemic Measure (as measured by CGM) | Acceptance Criteria (Implied: Safety & Effectiveness) | Reported Performance (CGM-Informed SmartBolus Calculator) |
|---|---|---|
| Time in range (70-180 mg/dL) | Expected to maintain time in range within acceptable levels given bolus calculations | 63.8% (SD 15.7) |
| Time spent 180 mg/dL (Hyperglycemia) | Expected to manage hyperglycemia | 34.0% (SD 16.0) |
| Time spent ≥ 250 mg/dL | Expected to manage high hyperglycemia | 9.7% (SD 10.3) |
| Time spent ≥ 300 mg/dL | Expected to manage very high hyperglycemia | 2.6% (SD 3.7) |
*Note: The primary analysis focused on comparing the CGM-informed SmartBolus Calculator with the standard one, and a statistically significant difference was observed for time spent
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