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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. 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 functions 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 OP5 Pod and OP5 Controller (which contains the OP5 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™ alqorithm (installed on the Pod) controls insulin delivery based on recent CGM values.

This document is an FDA 510(k) clearance letter and summary for the Insulet SmartAdjust™ technology. It states that the device is substantially equivalent to a previously cleared predicate device (K220394), with the only change being an update to the specifications for glucose sensor performance for compatible integrated continuous glucose monitors (iCGMs). This means the core algorithm and its performance were already established with the original clearance.

Therefore, the document does not contain the detailed study information typically found in a new device submission or a clinical trial report that directly proves the device meets specific acceptance criteria in a new clinical study. Instead, it relies on the substantial equivalence argument, implying that the previous studies for the predicate device, or studies demonstrating the updated iCGM performance, are sufficient.

Based on the provided text, here's what can be extracted and what cannot:

Information Available:

• Device Name: SmartAdjust™ technology
• Predicate Device: SmartAdjust™ technology (K220394)
• Change: Updated iCGM Performance Specifications per 21 CFR 862.1356(1)(iv).
• Conclusion: The subject device is substantially equivalent to its predicate. The differences do not raise new questions of safety and effectiveness.

Information NOT Available (because this is a substantial equivalence submission for a minor update, not a new clinical trial submission document):

• A table of acceptance criteria and the reported device performance: This document does not detail specific performance metrics or acceptance criteria for a new study, as it's an update to an already cleared device. The performance requirements were presumably met by the predicate device and the updated iCGM.
• Sample sizes used for the test set and the data provenance: Not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
• Adjudication method: Not applicable/provided for this type of submission.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable/provided.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is an algorithm/software, but the clinical performance data related to its efficacy (how well it manages glucose) would typically be from human-with-device studies from the original predicate submission. No new standalone study details are here.
• The type of ground truth used: Not specified, but for a glycemic controller, this would typically involve actual blood glucose measurements.
• The sample size for the training set: Not provided.
• How the ground truth for the training set was established: Not provided.

Reconstruction of "Acceptance Criteria" based on the document's type:

Since this is a 510(k) for an update, the "acceptance criteria" revolve around demonstrating that the change (updated iCGM specifications) does not negatively impact safety or effectiveness, and that the device still meets the requirements for its classification.

Table of "Acceptance Criteria" and "Reported Device Performance" as implied by a 510(k) for an update:

Study Information (based on the context of a 510(k) for an update):

• Sample size used for the test set and data provenance: No specific sample size for new clinical testing is mentioned. The approval hinges on the existing data for the predicate device and the updated iCGM meeting its own specifications. The data provenance for the original predicate would have included clinical trial data (likely prospective).
• Number of experts and qualifications, Adjudication method, MRMC study, Standalone performance: These details are not relevant to this specific 510(k) summary, as it's establishing equivalence based on a minor technical update, not presenting new clinical efficacy data for the core algorithm from scratch. Such studies would have been part of the original K220394 submission.
• Type of ground truth used: For the underlying technology (which is unchanged here), the ground truth for an automated glycemic controller would be actual blood glucose measurements, measured by a reference method (e.g., lab venous plasma glucose, or accurate point-of-care devices).
• Training Set Sample Size and Ground Truth Establishment: Not mentioned, as this is an established, already-trained algorithm.

In summary, this document is a regulatory approval for a minor update to an already-cleared medical device software, rather than a detailed report of a new clinical study. The "proof" lies in the argument of substantial equivalence to the predicate device, with the specific change (iCGM specifications) not introducing new safety or effectiveness concerns.

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