Search Results
Found 1 results
510(k) Data Aggregation
(400 days)
SmartAdjust technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, and pause delivery of insulin based on current and predicted glucose values. SmartAdjust technology is intended for the management of type 1 diabetes mellitus in persons 6 years of age and older. SmartAdjust technology is intended for single patient use and requires a prescription.
The Omnipod 5 iAGC (SmartAdjust technology) is a software-only medical device intended for the management of type 1 diabetes mellitus. The Omnipod 5 iAGC uses data from a connected iCGM along with user-defined parameters to predict future glucose trends and automatically increase, decrease, or suspend the delivery of insulin via a compatible alternate controller enabled (ACE) pump.
The Omnipod 5 iAGC software is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump, Omnipod 5 Bolus Calculator, and an interoperable iCGM. The Omnipod 5 iAGC is intended to be digitally connected to an iCGM and an ACE Pump.
The Omnipod 5 iAGC software resides on the Omnipod 5 ACE Pump (the Omnipod 5 Pod and Omnipod 5 App). The iAGC software is responsible for controlling insulin delivery via compatible ACE Pump when the system is in Automated Mode. iCGM data is transmitted from the iCGM to the ACE Pump via Bluetooth Low Energy technology. The Omnipod 5 iAGC uses this transmitted iCGM data in its calculations. The Omnipod 5 iAGC can be turned off, and the Omnipod 5 ACE Pump will operate in Manual Mode, which delivers insulin based on HCP- or user-defined Basal Programs.
The Omnipod 5 iAGC has three states of operation: Automated Mode, Automated: Limited, and Activity. In Automated Mode, the system calculates insulin delivery every 5 minutes based on the user-customizable glucose target (110–150 mg/dL). Automated: Limited is enabled when the Omnipod 5 iAGC is not receiving data from a connected iCGM for 20 minutes or more and during sensor warm-up. While in Automated: Limited, the user will receive no more than preprogrammed basal insulin. When a valid glucose value is received from the iCGM, the Omnipod 5 iAGC will resume delivery of insulin in full Automated Mode. Activity is a user-selected temporary feature intended for use during periods when insulin sensitivity is expected to be higher, such as during exercise. With Activity, the algorithm reduces insulin delivery and sets a temporary glucose target of 150 mg/dL.
Acceptance Criteria and Device Performance for SmartAdjust Technology
The SmartAdjust technology, an interoperable Automated Glycemic Controller (iAGC) for type 1 diabetes management, was evaluated through a clinical study. The acceptance criteria and reported device performance are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list pre-defined quantitative acceptance criteria for all aspects. Instead, the study aims to demonstrate improvements in glycemic control and safety compared to standard therapy. The "Change" columns in the glycemic results tables effectively represent the performance metrics, and a "P < 0.0001" indicates statistical significance for these changes, which serves as an implicit acceptance criterion for improvement.
Here's a summary of the key performance metrics from the clinical study, presented as a comparison to the standard therapy phase:
Glycemic Results Overall (24 hours)
| Characteristic | Acceptance Criteria (Improvement vs. Standard Therapy with P < 0.0001) | Reported Device Performance (Change with Omnipod 5) |
|---|---|---|
| Children (6 to 13.9 years) | ||
| Avg A1C, % | Significant decrease | -0.71%* |
| Avg sensor glucose, mg/dL | Significant decrease | -23* |
| Avg % time 70-180mg/dL | Significant increase | 15.6%* |
| Median % <54mg/dL | No significant increase or decrease (ideally stable or decreasing) | 0.04% |
| Median % <70mg/dL | No significant increase or decrease (ideally stable or decreasing) | 0.06% |
| Avg % >180mg/dL | Significant decrease | -15.1%* |
| Avg % ≥250mg/dL | Significant decrease | -9.4%* |
| Avg % ≥300mg/dL | Significant decrease | -5.1%* |
| Adolescents & Adults (14 to 70 years) | ||
| Avg A1C, % | Significant decrease | -0.38%* |
| Avg sensor glucose, mg/dL | Significant decrease | -8* |
| Avg % time 70-180mg/dL | Significant increase | 9.3%* |
| Median % <54mg/dL | Significant decrease (ideally) | -0.08%* |
| Median % <70mg/dL | Significant decrease (ideally) | -0.89%* |
| Avg % >180mg/dL | Significant decrease | -7.7%* |
| Avg % ≥250mg/dL | Significant decrease | -4.3%* |
| Avg % ≥300mg/dL | Significant decrease | -2.0%* |
Safety Results (Incidence of Adverse Events)
| Adverse Event Type | Acceptance Criteria (Low incidence, comparable to standard, or manageable) | Reported Device Performance (Events per person-month / Count) |
|---|---|---|
| Severe hypoglycemia | Low incidence, ideally no association with device malfunction | 0.004 events per person-month (3 events total, not attributable to system) |
| Diabetic ketoacidosis (DKA) | Low incidence, ideally no association with device malfunction | 0.001 events per person-month (1 event total, from suspected infusion site failure) |
| Other related adverse events | Acceptable and manageable rate | Hypoglycemia (non-severe): 1 (0.4%) / Hyperglycemia: 3 (1.3%) / Prolonged Hyperglycemia: 18 (6.7%) / Other: 16 (6.7%) |
*Change between standard therapy phase and Omnipod 5 System phase was significant (P < 0.0001).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 240 subjects. This included 112 children (6 to 13.9 years) and 128 adolescents and adults (14 to 70 years).
- Data Provenance: The data was collected from a multicenter, prospective clinical study conducted across 17 investigational sites. The document does not explicitly state the country of origin, but given the FDA submission, it is highly likely the study was conducted in the United States or in accordance with international good clinical practice standards acceptable to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The study involved a prospective clinical trial in human subjects with Type 1 Diabetes. In this context, the "ground truth" for glycemic control and safety are direct measures from the subjects (A1C, sensor glucose readings, adverse event reporting) rather than expert consensus on images or interpretations. Therefore, there were no "experts" establishing a ground truth for a test set in the traditional sense of medical image analysis. Clinical endpoints were measured directly from the study participants.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for a "test set" in the context of expert review, as the ground truth was derived from direct clinical measurements. However, adverse events and clinical outcomes would have been reviewed and documented by clinical investigators and potentially an independent medical monitor or data safety monitoring board, which is standard for clinical trials.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative medical devices (e.g., imaging AI) where human readers interpret cases with and without AI assistance. The SmartAdjust technology is a therapeutic device that directly controls insulin delivery, and its effectiveness is measured by clinical outcomes (e.g., A1C, time in range) in patients.
6. Standalone Performance Study
Yes, a standalone study was conducted. The clinical study described is a standalone performance study of the SmartAdjust technology (Omnipod 5 iAGC) in automated mode, meaning the algorithm was operating without human intervention for insulin delivery adjustments. The study compared the device's performance against a "standard therapy phase" which served as a baseline. The algorithm made automatic adjustments based on iCGM data, and the outcomes were observed directly in patients.
7. Type of Ground Truth Used
The ground truth used was outcomes data from human subjects. Specifically:
- Glycemic Control: Measured by laboratory-assessed A1C, and continuous glucose monitor (CGM) data (e.g., average sensor glucose, percentage of time in various glucose ranges: 70-180 mg/dL, <54 mg/dL, <70 mg/dL, >180 mg/dL, ≥250 mg/dL, ≥300 mg/dL).
- Safety: Measured by the incidence of severe hypoglycemia and diabetic ketoacidosis (DKA), as well as other adverse events reported during the clinical trial.
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set. This is typical for device submissions where the algorithm's development (training) might involve proprietary data and methods not usually detailed in the 510(k) summary. The clinical study focuses on the validation and performance of the fully developed device.
9. How the Ground Truth for the Training Set Was Established
The document does not specify how the ground truth for any potential training set was established. Given the nature of an automated glycemic controller, it's plausible that the training could involve:
- Simulated physiological models of diabetes.
- Retrospective data from patients with T1D (e.g., CGM data, insulin delivery logs, meal information).
- Rule-based logic derived from clinical guidelines and expert knowledge, rather than a "trained" machine learning model in the conventional sense.
Without further information in the submission, the exact method for establishing ground truth for training cannot be determined.
Ask a specific question about this device
Page 1 of 1