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510(k) Data Aggregation
(400 days)
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 < 70 mg/dL (Hypoglycemia) | Expected to minimize hypoglycemia, especially post-bolus | 2.1% (SD 2.0) Lower than Standard SmartBolus Calculator |
| Time spent < 54 mg/dL (Severe Hypoglycemia) | Expected to minimize severe hypoglycemia | 0.3% (SD 0.7) |
| 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 < 70 mg/dL, indicating improvement in minimizing hypoglycemia.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 25 participants
- Data Provenance: The document does not explicitly state the country of origin. The study appears to be a prospective clinical study, as participants actively used the device in two distinct phases of device usage.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The "ground truth" for the clinical study was measured directly by CGM data. There is no mention of experts establishing ground truth for the bolus calculations themselves or for the CGM data.
4. Adjudication Method for the Test Set
This information is not provided in the document. Given that the clinical study involved direct physiological measurements (CGM data), it is unlikely that an adjudication method for "ground truth" labels was necessary in the traditional sense.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
An MRMC study was not conducted, and therefore, there is no information on the effect size of human readers improving with AI assistance. This device is an automated bolus calculator, not an AI assisting human interpretation of images or data in an MRMC setting.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The presented clinical study is a comparison of two versions of the SmartBolus Calculator (standard vs. CGM-informed) in a human-in-the-loop setting, as users still had the option to deliver, modify, or cancel the suggested dose. While the algorithm calculates the dose standalone, the clinical study evaluates its performance within the user's decision-making process. The document also mentions "Software Validation" as a non-clinical performance test, which would likely include standalone algorithm validation, but specific details of such a study are not provided in terms of performance metrics or acceptance criteria.
7. The Type of Ground Truth Used
The "ground truth" for the clinical performance data was continuous glucose monitoring (CGM) data. This is objective physiological measurement data collected from the participants.
8. The Sample Size for the Training Set
This information is not provided in the document. The document describes a clinical study as "Summary of Clinical Performance Data" which would be considered the test set for validating the device's clinical impact. There is no mention of a separate training set for the algorithm "training" itself within the scope of this regulatory submission summary. The bolus calculator is based on established algorithms for insulin dose calculation.
9. How the Ground Truth for the Training Set was Established
This information is not provided in the document. As mentioned in point 8, the document describes a clinical validation study rather than a de novo algorithm training process. The bolus calculation algorithm is based on programmable settings (correction factor, insulin to carbohydrate ratio, target glucose value) and real-time data (glucose readings, carbs, IOB), which are clinical parameters established through diabetes management principles rather than a "ground truth" derived from a specific training dataset in the AI/ML sense.
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