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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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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 proposed device provides for the management of insulin therapy and blood qlucose monitoring by patients with diabetes mellitus. It is 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) with an embedded blood glucose meter. The PDM 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 provided text does not contain information about an AI/ML-powered device. Instead, it describes a substantial equivalence determination for the OmniPod Insulin Management System, which is an infusion pump with a built-in glucose meter. The document details modifications to this existing medical device and the performance testing conducted to ensure it remains substantially equivalent to a previously cleared predicate device.

Therefore, I cannot populate the requested table and answer the questions related to AI device acceptance criteria, human reader improvement with AI, or AI ground truth establishment.

The document focuses on the safety and performance of an insulin pump and glucose meter, with no mention of artificial intelligence or machine learning components.

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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 proposed device provides for the management of insulin therapy and blood glucose monitoring by patients with diabetes mellitus. It is 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) with an embedded blood glucose meter.

This document describes the 510(k) premarket notification for the Insulet OmniPod Insulin Management System (K160252). The notification details modifications made to the device and provides evidence of performance testing to support its substantial equivalence to a predicate device (K122953).

Here's the breakdown of the acceptance criteria and supporting studies based on the provided text:

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

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 explicitly state the specific sample sizes for each test mentioned (e.g., number of Pods for cannula depth testing). It generally refers to "all Pod samples tested" or "testing was conducted."

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated for these performance tests. The manufacturing site is listed as Flextronics Industrial (Shenzhen) Co., LTD. in Shenzhen, Guangdong, China. It is highly probable the performance testing was conducted at or in conjunction with the manufacturing site or the submitting company (Insulet Corporation, Billerica, MA, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the provided document. The performance data presented refers to engineering and bench testing of mechanical and material properties of the device, not clinical studies requiring expert interpretation of diagnostic output.

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

This information is not applicable. As stated above, these are engineering and bench tests, not clinical studies requiring human adjudication of ground truth.

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 described is an insulin management system with a built-in glucose meter, not an AI-based diagnostic imaging or interpretation device.

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

This information is not applicable. The device is a physical medical device (infusion pump and glucose meter), not a standalone algorithm. The performance tests are for the physical components and their functionality.

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

For the performance tests described, the "ground truth" or reference standards are the device specifications and requirements established by the manufacturer and relevant industry standards (e.g., ISO 14971, ISO 10993). For example, for cannula depth, the ground truth is the specified depth. For biocompatibility, it's the acceptance criteria defined by ISO 10993.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not a machine learning model that requires a training set.

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

This information is not applicable. See point 8.

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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 capillary whole blood (in vitro) from the fingertip.

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

OneTouch® Verio™ Test Strips are used with the built-in blood glucose meter with One Touch Verio technology for the quantitative measurement of blood glucose in fresh capillary whole blood drawn from the fingertips.

OneTouch Verio Control Solutions are used to check that the meter and test strips are working together properly and that the test is performing correctly.

The OmniPod® Insulin Management System is a tubeless insulin pump 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 capillary whole blood (in vitro) from the fingertip. This System is comprised of two primary components, the insulin pump (Pod) and the remote controller (Personal Diabetes Manager). The Personal Diabetes Manager incorporates LifeScan OneTouch Verio blood glucose measurement capability through a built in blood glucose meter. The blood glucose meter uses One Touch Verio Test Strips. OneTouch Verio Level 3 (Mid) and OneTouch Verio Level 4 (High) Control Solutions are used to check that the meter and test strips are working together properly. OneTouch Verio Test Strips are included in the Starter Kit. OneTouch Verio Control Solutions are not included in the Starter Kit and must be purchased separately.

Here's a breakdown of the acceptance criteria and study information for the OmniPod Insulin Management System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on demonstrating substantial equivalence to a predicate device (OmniPod Insulin Management System K122953). Therefore, the "acceptance criteria" are generally that the new device meets the performance and safety standards established for the predicate and relevant industry guidance/standards (e.g., ISO, IEC). The reported performance is that the device met these criteria.

Note: The document consistently states that the device "met" or "successfully met" these requirements, or that testing was "completed" and "confirmed" the device to be substantially equivalent. Specific quantitative performance figures are generally not provided in this summary.

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

• Sample Size for Test Set: Not explicitly stated for any of the individual tests. The document mentions "LifeScan completed appropriate testing" and "LifeScan completed a clinical study," suggesting the test sets were those used in LifeScan's validation of the integrated OneTouch Verio technology.
• Data Provenance: Not explicitly stated. The manufacturer (Insulet) is based in the USA. LifeScan, the developer of the integrated blood glucose meter technology, is also a US-based company generally. The clinical study for the BGM fulfilled requirements of ISO 15197:2003 (E), which is an international standard. It is most likely US-based data, but not definitively stated.
• Retrospective or Prospective: Not explicitly stated. Clinical studies are typically prospective, but this is not confirmed here.

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

• This information is not provided in the document. For the blood glucose measurement component, the "ground truth" would typically come from laboratory reference methods, but the number and qualifications of technicians/experts are not mentioned. For the overall system, the ground truth is established by meeting the specified performance and safety standards.

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

• No. This device is an insulin management system with an integrated blood glucose meter, not an AI-powered diagnostic imaging device that would typically involve human readers. Therefore, an MRMC study and AI assistance effect size are not applicable here.

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

• For the blood glucose meter component, the accuracy studies (e.g., repeatability, precision, method comparison) represent the "standalone" performance of the algorithm and sensor. The document states LifeScan completed these evaluations and they "confirmed the proposed device to be substantially equivalent to the predicate device."
• For the insulin pump component, the various engineering and safety tests (e.g., physical characteristics, software, electrical safety, battery life) represent its standalone performance without a human in the loop affecting its core function.

7. The Type of Ground Truth Used

• For the insulin pump components: The ground truth is established by adherence to recognized medical device standards (e.g., IEC 60601-2-24, IEC 60601-1), industry guidance from the FDA, and meeting self-defined hardware and software specifications. This is a mix of engineered specifications and regulatory compliance.
• For the blood glucose meter component: The ground truth for accuracy and performance parameters (e.g., repeatability, linearity) is typically established by laboratory reference methods (e.g., YSI analyzer for glucose concentration). For the clinical user performance, it would be a comparison to a "validated method" as stated, which likely refers to these laboratory reference methods performed by trained personnel.

8. The Sample Size for the Training Set

• This information is not applicable and therefore not provided. The OmniPod Insulin Management System, as described in this 2014 510(k) summary, does not appear to use machine learning algorithms that require a "training set" in the modern sense. It's a hardware-based electromechanical device with embedded software.

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

• This information is not applicable as there is no mention of a training set for machine learning.

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The OmniPod® Insulin Management System is intended for subcutaneous (below the skin) delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

The OmniPod Insulin Management System is a tubeless insulin pump and is intended for intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. This system is comprised of two primary components, the insulin pump (pod) and the remote controller (Personal Diabetes Manager). The proposed device is a modification to the OmniPod Insulin Management System that removes the integrated blood glucose meter from the Personal Diabetes Manager.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets and reported device performance for each criterion. Instead, it broadly states that "All testing met acceptance criteria." and "predetermined acceptance criteria was met."

The document focuses on demonstrating substantial equivalence to a predicate device (OmniPod Insulin Management System, K122953) through various verification and validation activities. The acceptance criteria for these tests were to successfully meet the relevant requirements of established standards and guidance documents.

Study Details

Based on the provided text, the submission is focused on demonstrating substantial equivalence for a device modification (removal of an integrated blood glucose meter). Therefore, the "study" described is a series of non-clinical verification and validation tests rather than a traditional clinical study with human subjects.

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

   • Sample Size: Not explicitly stated for each test. The document refers to "the proposed device" implying a general set of test units.
   • Data Provenance: Not specified. It's implied to be from Insulet Corporation's internal testing. The country of origin of the data is not mentioned, but the company is based in Bedford, MA, USA. The tests are prospective in the sense that they were performed on the modified device to confirm its performance.

2. 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)

   • Not applicable. This was a non-clinical device performance and safety testing, not a study requiring expert interpretation or establishment of ground truth in a diagnostic or clinical sense. The "ground truth" for these tests would be the requirements outlined in the specified international standards (e.g., IEC 60601-2-24, IEC 60601-1) and FDA guidance documents.

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

   • Not applicable. This refers to consensus among multiple human reviewers for certain types of studies, which is not relevant to this submission. The tests were objective measurements against predefined criteria.

4. 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

   • No MRMC comparative effectiveness study was done. This information is typically relevant for AI/radiology devices, which is not the nature of this submission (an insulin pump).

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

   • Not explicitly described in terms of "standalone" algorithm performance. The device itself (insulin pump) operates without continuous "human-in-the-loop" once programmed, but the software verification was done for the device as a whole. This question is more aligned with AI diagnostic tools.

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

   • Not applicable in the conventional sense of clinical ground truth. The "ground truth" for assessing the modified device's performance relies on adherence to established international standards and FDA guidance for medical device safety and efficacy (e.g., IEC standards for electrical safety, drop and vibration, EMC).

7. The sample size for the training set

   • Not applicable. This is a medical device modification submission, not a machine learning or AI algorithm development that would have a "training set."

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

   • Not applicable, as there was no training set for an AI algorithm.

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