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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 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 subject devices provide for the management of insulin therapy by patients with diabetes mellitus. The devices are 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 incorporates 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.

The systems are for prescription use only.

This document is a 510(k) premarket notification for the Omnipod Insulin Management System and Omnipod DASH Insulin Management System. It primarily discusses a labeling change to add Fiasp U100 insulin as compatible and asserts substantial equivalence to a previously cleared device (K182630). Therefore, the information typically found for acceptance criteria and a study proving device performance in a de novo or original 510(k) submission (which often includes specifics on a clinical trial or performance study with detailed metrics) is not present here.

Based on the provided document, I can extract the following relevant information regarding acceptance criteria and studies:

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

The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance metrics in the way a clinical study report would. Instead, it states that:

• Acceptance Criteria Mentioned: "Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the devices are safe for use." However, the specific criteria themselves are not listed.
• Reported Device Performance:
  • "Drug Stability and Compatibility; In-use stability and leachables testing was conducted with Fiasp U100 insulin to verify and validate that the systems do not adversely affect the insulin."
  • "Fiasp stability testing in Omnipod Pods"
  • "Leachables study"

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

The document does not specify the sample sizes for the stability and leachables testing, nor does it provide information about the provenance of the data (e.g., country of origin, retrospective or prospective nature).

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 applicable to the type of testing described (drug stability and leachables) and is therefore not present in the document. These tests are laboratory-based and do not involve expert interpretation or ground truth establishment in the same way a diagnostic device might.

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

This information is not applicable to the type of testing described (drug stability and leachables) and is therefore not present 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

This information is not applicable. The device is an insulin management system, not an AI-assisted diagnostic tool requiring MRMC studies.

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

This information is not applicable in the context of the described modifications. The primary device function (insulin delivery) is not an algorithm-only standalone performance that would be assessed in this manner for the stated purpose of the submission. The "dose calculator" is mentioned within the context of the PDM, implying human interaction.

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

For the stability and leachables testing, the "ground truth" would be established by scientific analytical methods (e.g., chemical assays, chromatography) to measure insulin degradation, chemical composition of leachates, and ensure the drug substance remains within predefined acceptable ranges, as per established pharmaceutical and medical device testing standards. The document does not explicitly detail these laboratory "ground truth" methods but refers to "Fiasp stability testing in Omnipod Pods" and a "Leachables study."

8. The sample size for the training set

The document describes a 510(k) submission for a modification (labeling change for compatible insulins) to existing devices. There is no mention of a "training set" as would be used for machine learning or AI algorithm development because that is not the nature of this submission. The testing described (stability, leachables) does not involve training sets.

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

As there is no "training set" reported for this submission, this question is not applicable.

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Omnipod Insulin Management System

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 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.

Omnipod DASH Insulin Management System

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 document is a 510(k) summary for the Omnipod Insulin Management System and Omnipod DASH Insulin Management System. It describes modifications to an existing device rather than a new device and thus does not contain the specific information requested in the prompt regarding a study that proves the device meets specific acceptance criteria with detailed statistical analysis.

However, based on the Performance Data and Standards Compliance section, I can extract information about the types of testing performed and the general conclusions, even if the detailed acceptance criteria and study designs are not fully elaborated.

Here's an attempt to answer using the available information, noting where specific details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The document does not provide the specific numerical acceptance criteria (e.g., specific thresholds for leachables, precise depth specifications, or quantitative results from the stability/compatibility testing). It states that criteria were "met" or "verified" or "validated."

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Real-world data analysis: An analysis of post-market data gathered from devices with the modified soft cannula was conducted..."

• Sample Size: Not specified.
• Data Provenance: Retrospective, post-market data. The country of origin is not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable as this was not a diagnostic image-based AI study relying on expert ground truth. The "ground truth" for cannula performance or insulin stability would be derived from laboratory measurements and clinical outcomes, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable for this type of device modification study. Adjudication methods like 2+1 or 3+1 typically refer to reconciliation of discrepancies among multiple expert readers in diagnostic studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not mentioned. This type of study is more common for diagnostic imaging AI. The document focuses on performance testing of the device's physical and chemical properties and post-market safety.

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

The device is an insulin pump system with a bolus calculator, not a standalone AI algorithm for diagnosis. Therefore, this question isn't directly applicable in the typical sense of AI standalone performance. The "algorithm" for dose calculation is part of the system's intended function, and its overall safety and effectiveness were assessed as part of the system.

7. The Type of Ground Truth Used

• For Drug Stability and Compatibility: Laboratory analytical results for insulin integrity (e.g., potency, purity, presence of leachables).
• For Soft Cannula Studies: Engineering measurements and specifications for insertion depth and insulin infusion depth.
• For Safety and Effectiveness (Real-world data): Clinical outcomes, adverse event reports, and other post-market surveillance data.
• For Sterilization: Microbiological test results (bioburden) and compliance with sterilization standards.
• For Risk Management: Verification activities demonstrating that risks identified were mitigated to an acceptable level as defined by ISO 14971.

8. The Sample Size for the Training Set

Not applicable. This document describes a modification to an existing device, and the "real-world data analysis" was for post-market validation, not for training a machine learning model in the context of an AI device. The bolus calculator is rule-based and user-programmed, not an AI model requiring a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there's no mention of a traditional "training set" for an AI model.

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