Search Results

SmartAdjust™ technology is intended for use with compatible integrated continuous glucose monitors (iCGM) and alternate controller enabled (ACE) pumps to automatically increase, decrease, 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 2 years of age and older and type 2 diabetes mellitus in persons 18 years of age and older. SmartAdjust™ technology is intended for single patient use and requires a prescription.

SmartAdjust™ technology is a software-only device that enables automated insulin delivery by taking in glucose inputs from a connected iCGM and calculating insulin micro-bolus outputs for delivery by a connected ACE Pump.

SmartAdjust™ technology is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 ACE Pump and the SmartBolus Calculator regulated devices. The Omnipod 5 ACE Pump and the SmartBolus Calculator are functionally independent from SmartAdjust™ technology. SmartAdjust™ technology is intended to be digitally connected to a third party iCGM, the Omnipod 5 ACE Pump, and the SmartBolus Calculator.

The SmartAdjust™ technology software is installed on both the Omnipod 5 Pod and Omnipod 5 Controller (which contains the Omnipod 5 App), the 2 physical components that make up the Omnipod 5 System.

The Omnipod 5 System is a hybrid closed loop system and therefore can operate in either open loop (Manual Mode; SmartAdjust™ technology disabled) or closed loop (Automated Mode; SmartAdjust™ technology enabled). When Automated Mode is turned on, the SmartAdjust™ algorithm (installed on the Pod) controls insulin delivery based on recent CGM values.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

This document describes the 510(k) premarket notification for the SmartAdjust™ Technology, which is an interoperable automated glycemic controller. The submission aims to expand the indications for use to include individuals with Type 2 Diabetes Mellitus aged 18 years and older, in addition to the existing indication for Type 1 Diabetes Mellitus.

1. A table of acceptance criteria and the reported device performance

The provided text doesn't explicitly list a table of "acceptance criteria" with numerical targets in a typical performance study format. However, it does report on a primary safety endpoint from a clinical study which effectively serves as a key performance metric for the expanded indication.

Here's a table based on the information provided, focusing on the clinical study's primary safety endpoint:

2. Sample sized used for the test set and the data provenance

• Sample Size for Test Set (Clinical Study): 343 participants
• Data Provenance: The document doesn't explicitly state the country of origin. It indicates it was a "clinical study" performed by Insulet, implying it was prospective within the context of validating the device for T2DM.

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 clinical study evaluated patient outcomes (HbA1c, adverse events) rather than relying on expert consensus for ground truth on specific assessments.

4. Adjudication method for the test set

This information is not provided in the document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically relevant for interpretative devices where human experts read cases and the AI provides assistance. The SmartAdjust™ technology is an automated glycemic controller that directly delivers insulin based on algorithms, not an interpretive aid for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the clinical study essentially assessed the standalone performance of the SmartAdjust™ algorithm (within the Omnipod 5 System) in a human-in-the-loop context. While users interact with the system, the key performance metrics (HbA1c, safety events) are a direct consequence of the algorithm's automated insulin delivery decisions. The document states: "When Automated Mode is turned on, the SmartAdjust™ algorithm (installed on the Pod) controls insulin delivery based on recent CGM values." The clinical study then validated this control for T2DM.

7. The type of ground truth used

The ground truth for the clinical study was based on clinical outcomes data, specifically:

• HbA1c measurements (a standard biochemical marker for long-term glucose control)
• Observation and reporting of adverse events (DKA, severe hypoglycemia, hyperosmolar hyperglycemic syndrome)

8. The sample size for the training set

The document does not provide information on the sample size used for the training set of the SmartAdjust™ algorithm. This information is typically not included in a 510(k) summary for a device like an automated insulin delivery system, as the algorithm's development and validation might involve proprietary datasets and methods outside the scope of the premarket notification for an expanded indication.

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 (if any specific to machine learning) was established. Given the nature of a glycemic control algorithm, training might involve simulated data, retrospective patient data with known glucose values and insulin needs, or data from prior clinical trials. However, the document does not specify this. The clinical study described in the summary is for validation of the algorithm's performance with the expanded indication, not for its initial training.

Ask a specific question about this device