(24 days)
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.
§ 862.1358 Insulin therapy adjustment device.
(a)
Identification. An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations;
(ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated;
(iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations;
(iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification;
(v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures;
(vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and
(vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.
(2) The device must not be intended for use in implementing automated insulin dosing.
(3) Your 21 CFR 809.10(b) labeling must include:
(i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device;
(ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations;
(iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and
(iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).