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The Omnipod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger.

The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared.

Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm, and palm. Abbott FreeStyle Control Solutions are used to verify that the meter and test strips are working together properly and that the test is performed correctly.

The Omnipod DASH Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Additionally, the Omnipod DASH System is interoperable with a compatible blood glucose meter to receive and display glucose measurements.

The subject devices provide for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. They are each comprised of two primary components: the disposable insulin infusion pump (Pod) and an associated wireless remote controller referred to as the Personal Diabetes Manager (PDM). The PDMs incorporate a suggested bolus calculator which aids the user in determining the insulin bolus dosage needed based on carbohydrates ingested, most recent blood glucose reading. programmable correction factor, insulin to carbohydrate ratio, target blood glucose value, and Insulin on Board (IoB).

The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back or abdomen, the thigh area, or any site that has a layer of fatty tissue available. It is held in place by an adhesive pad and provides up to three days of insulin before it is removed and replaced with a new Pod. The PDM is a handheld device that controls the Pod. The user interfaces with the device system through the PDM, where they control basal and bolus delivery and various insulin program settings and calculations. The PDM also has a food library to assist with carbohydrate calculations, and it maintains several variables in a history log for the viewer to track their diabetes therapy. The Omnipod Insulin Management System PDM has an integrated blood glucose meter and communicates with the Pod using wirelessly using secure, low power, bi-directional radio frequency (RF) communications at 433.92MHz. The Omnipod DASH Insulin Management System PDM does not have an integrated blood glucose meter, but is interoperable with a compatible blood glucose meter to receive and display glucose measurements. The Omnipod DASH PDM communicates to the Pod and a compatible blood glucose meter using Bluetooth Low Energy.

Both systems are for prescription use only.

The provided text describes modifications to the Omnipod Insulin Management System and Omnipod DASH Insulin Management System to include Lyumjev U100 insulin in their labeling as a compatible insulin. The submission emphasizes that the devices are substantially equivalent to their predicate devices cleared in K192659 because the only change is the addition of this new insulin and that performance testing demonstrates no adverse effect on safety when using Lyumjev U100.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly state "acceptance criteria" in a tabulated format for the Lyumjev U100 insulin. Instead, it refers to broad performance categories and comparative characteristics with the predicate device. The core "acceptance criteria" can be inferred as demonstration that the device's performance (delivery accuracy, flow rates, etc.) is not negatively impacted and that the insulin's stability is maintained when used with Lyumjev U100.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide specific sample sizes for the "in-use stability and leachables testing" conducted with Lyumjev U100 insulin. It also does not specify the country of origin of the data or whether the test was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The testing described (drug stability/compatibility) is laboratory-based and does not involve human expert interpretation for ground truth establishment in the traditional sense of image analysis or diagnostic studies.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which do not appear to be the case here.

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

An MRMC comparative effectiveness study was not done. The device is an insulin management system, not an AI-assisted diagnostic tool that would involve human readers.

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

The testing described (drug stability and compatibility) is inherently "standalone" in that it assesses the physical and chemical interaction between the device components and the insulin, independent of human interaction within the testing framework. However, this is not an "algorithm-only" performance as would be seen in AI device submissions. The submission is for hardware/software system compatibility with a new drug.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the stability and compatibility testing would be established through laboratory analytical methods (e.g., chemical assays, spectroscopic analysis) to determine the integrity and concentration of the insulin, as well as the presence of leached substances, compared against established specifications for the insulin and device materials. This is not expertise-based ground truth like pathology or outcomes data.

8. The sample size for the training set

This information is not applicable and not provided. This submission is for compatibility with a new insulin, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI/ML algorithm.

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