Search Results

The Omnipod 5 ACE Pump (Pod) is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The Omnipod 5 ACE Pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. The Omnipod 5 ACE Pump is intended for single patient, home use and requires a prescription.

Device Description

The Omnipod 5 ACE Pump is intended to deliver insulin via a tubeless insulin pump (the Pod) that wirelessly connects to and receives insulin delivery commands from the Omnipod 5 App, which is installed on a locked-down Android controller device or a user's personal smartphone device. The predicate device allowed the user to download the Omnipod 5 App to an Android compatible phone. This submission includes an iOS compatible Omnipod 5 App to allow users to download it to a compatible iPhone.

The Omnipod 5 ACE Pump is part of the Omnipod 5 Automated Insulin Delivery System, which also includes SmartAdjust Technology (iAGC), and the SmartBolus Calculator. SmartAdjust Technology and the SmartBolus Calculator functionally independent from the Omnipod 5 ACE Pump. The Omnipod 5 ACE Pump is intended to be digitally connected to a third party iCGM, SmartAdjust Technology, and the SmartBolus Calculator.

The Omnipod 5 ACE Pump can operate in Manual Mode, delivering insulin based on userprogrammed basal rates, or in Automated Mode, where insulin is automatically delivered based on the calculations and command of a compatible iAGC. Currently, the Omnipod 5 ACE Pump is compatible with SmartAdjust Technology, the software which is pre-installed on the Pod and the App. Future alternate controllers may be established for use with the Pod, in which case the software modules of the SmartAdjust Technology would be disabled. The Pod is a bodywearable insulin pump that affixes to the user on the back of the arm, the lower back, the 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 Omnipod 5 App is a software application installed on a handheld touchscreen device (Android and iOS) that connects to the Pod via Bluetooth Low Energy (BLE) and serves as the user interface of the system. In addition to programmed basal delivery and automated insulin delivery, the Omnipod 5 ACE Pump allows users to deliver bolus doses at values that are either inputted manually or calculated by the SmartBolus Calculator based on the user's settings and user-entered parameters. The Pod has the ability to connect to a compatible iCGM through BLE and receive data for use with SmartAdiust Technology and the SmartBolus Calculator.

The Omnipod 5 App has the ability to wirelessly connect to the Insulet Cloud which it utilizes for registering new devices, authenticating users, ensuring hardware devices and host operating systems are compatible, and completing over the air software (OTA) and firmware (FOTA) updates.

AI/ML Overview

The provided text is a 510(k) summary for the Omnipod 5 ACE Pump, which describes the addition of an iOS compatible mobile application. The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K203768).

Based on the provided text, the acceptance criteria and study details are primarily related to software verification and validation, interoperability, cybersecurity, electrical safety and EMC, and human factors validation for the new iOS application, rather than clinical performance of the insulin delivery itself (as the Pod itself was not modified).

Here's an attempt to structure the information based on your request, highlighting what is and isn't explicitly stated in the document:

Device: Omnipod 5 ACE Pump (with added iOS compatible Omnipod 5 App)
Purpose of Submission: To add a new mobile application compatible with iOS mobile devices. The Omnipod 5 App (iOS) is the new configuration being added to the previously cleared Omnipod 5 ACE Pump.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several types of performance testing and their adherence to standards and regulations. It doesn't present specific quantitative acceptance criteria or detailed performance metrics in a tabular format that is typically seen for accuracy, sensitivity, or specificity in AI/ML medical devices. Instead, it states that tests were performed and demonstrated that predetermined acceptance criteria were met and the device is safe and effective for use.

Category	Acceptance Criteria / Standard Compliance	Reported Device Performance
Risk Management	Compliance with ISO 14971:2019.	"Verification activities, as required by the risk analysis, demonstrated that the predetermined acceptance criteria were met and the device is safe for use."
Software Validation	Compliance with IEC 62304:2015-06 and FDA’s guidance “General Principles of Software Validation – Issued January 11, 2002,” and “Content of Premarket Submissions for Device Software Functions - Issued June 2023.”	"Software verification and validation testing were performed..." "Software documentation was provided..." "Software verification testing has demonstrated the device records timestamped critical events, including information related to its state, user inputs, and device settings, as required by the ACE Pump special controls." (for Data Logging)
Interoperability	Adherence to FDA Guidance “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff - Issued September 6, 2017.” Specifies validated interface specifications, partnership agreements, and post-market reporting.	"Interoperability documentation was provided as is relates to changes due to the Omnipod 5 App (iOS) according to the FDA Guidance..."
Cybersecurity	Compliance with various FDA cybersecurity guidances (2014, 2016, March 2023, April 2022 draft).	"a cybersecurity analysis was performed for the OP5 ACE Pump with the Omnipod 5 App (iOS)... In addition, Insulet has provided a software bill of materials and penetration testing."
Electrical Safety & EMC	Compliance with IEC 60601-1:2020-08 and IEC 60601-1-2:2020-9, and FDA guidances on Electromagnetic Compatibility and Radio Frequency Wireless Technology.	"testing was performed to verify that the Omnipod 5 ACE Pump with the Omnipod 5 App (iOS) meets its requirement to comply with IEC 60601-1:2020-08... and IEC 60601-1-2:2020-9..."
Human Factors Validation	Compliance with IEC 62366:2015-06, HE75:2009(R)2018, and FDA’s guidance “Applying Human Factors and Usability Engineering to Medical Devices - Issued February 3, 2016.”	"A robust validation evaluation was performed to demonstrate safe and effective use of the Omnipod 5 App (iOS) with intended users in the expected use environments, including associated training and accompanying documentation. The results of the validation demonstrate that the device has been found to be safe and effective for the intended users, uses, and use environments."
Special Controls (21 CFR 880.5730)	Evaluation supports safety and effectiveness.	"evaluation of the Special Controls for this device (regulation 21 CFR 880.5730) supports the safety and effectiveness of the device." "Through performance testing, the Subject device has been shown to meet the Alternate Controller Enabled Insulin Pump special controls..."

Note on Insulin Delivery Accuracy: The document states that the "Pod Delivery Accuracy (tested per IEC 60601-2-24)" for basal and bolus rates is a characteristic of the predicate device and is unchanged for the subject device. It is listed as:

Basal: ± 5% at rates ≥ 0.05 U/hr
Bolus: ± 5% for all set values ≥ 1.0 unit, ± 0.05 unit for set values < 1.0 unit
However, the current submission focuses on the new mobile app, not the Pod's fundamental insulin delivery mechanism.

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

The document does not specify quantitative sample sizes for the various testing protocols (e.g., software validation, human factors validation). It broadly refers to "performance testing" being completed.

Data Provenance: Not explicitly stated as retrospective or prospective data in the context of clinical studies for direct performance evaluation. The testing described is primarily non-clinical, involving software validation, cybersecurity analysis, and human factors validation. The device is a pump with an app, not an AI/ML algorithm that analyzes patient data to provide a diagnosis or risk assessment.

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

N/A. This submission is for an Alternate Controller Enabled Pump (ACE Pump) with a new mobile application. It's not an AI/ML diagnostic or prognostic device where expert ground truth interpretation of images or other clinical data would be required. The "ground truth" for this device's validation is adherence to engineering and usability standards and ensuring the software functions as intended and securely.

4. Adjudication Method for the Test Set

N/A. Not applicable for this type of device submission. Adjudication methods like 2+1 or 3+1 typically apply to the establishment of ground truth in image-based diagnostic AI/ML models.

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

No, an MRMC comparative effectiveness study was not done. This type of study focuses on how AI assistance impacts human reader performance, typically in diagnostic tasks. The Omnipod 5 ACE Pump with its iOS app is an insulin delivery system and its controlling interface, not a diagnostic AI.

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

The "algorithm only" performance for an insulin pump would refer to its ability to accurately deliver insulin based on programmed rates or commands. The document states that the Omnipod 5 ACE Pump's Pod (insulin pump itself) has not been modified, and therefore, performance testing applicable only to the Pod was not completed for this submission. The original validation of the Pod's insulin delivery accuracy (referenced in the table) would be considered its standalone performance. The new submission focuses on the software application for iOS as the controller. The software's performance is validated through various non-clinical tests (software validation, interoperability, cybersecurity, human factors) to ensure it reliably sends commands to the Pod.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the established technical standards, regulatory guidelines, and functional requirements for medical device software, cybersecurity, electrical safety, and human factors. For instance:

Software Validation: Ground truth is defined by the functional specifications and requirements of the software.
Cybersecurity: Ground truth is defined by cybersecurity best practices and regulatory guidance.
Human Factors Validation: Ground truth is defined by usability engineering principles and standards, demonstrated by the device being "safe and effective for the intended users, uses, and use environments" after testing.

8. The Sample Size for the Training Set

N/A. The Omnipod 5 ACE Pump and its associated app are not explicitly described as an AI/ML device that uses a "training set" in the context of supervised learning for a diagnostic or prognostic task. The software development process would involve iterative testing and debugging, but this is distinct from training a machine learning model on a labeled dataset.

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

N/A, as there is no mention of an AI/ML training set in the context of this device and its submission.

Ask a Question

Ask a specific question about this device

K Number

K203768

Device Name

Omnipod 5 ACE Pump (Pod)

Manufacturer

Insulet Corporation

Date Cleared

2022-01-27

(400 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K191679

Predicate For

K231826

Intended Use

Device Description

The Omnipod 5 alternate controller enabled (ACE) Pump is intended to deliver insulin via a tubeless insulin pump (the Pod) that wirelessly connects to and receives insulin delivery commands from the Omnipod 5 Application (App), which is installed on a locked-down controller device or a user's personal compatible smartphone device.

The Omnipod 5 ACE Pump is part of the Omnipod 5 Automated Insulin Delivery System, which also includes the Omnipod 5 Interoperable Automated Glycemic Controller (iAGC), Omnipod 5 Bolus Calculator, and the third-party Dexcom G6 iCGM. Omnipod 5 iAGC and Bolus Calculator functions are functionally independent from the Omnipod 5 ACE Pump. The Omnipod 5 ACE Pump is intended to be digitally connected to the iCGM, the iAGC, and the Bolus Calculator.

The Pod is a body-wearable insulin pump that affixes to the user on the back of the arm, the lower back, the 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 Omnipod 5 App is an Android software application installed on a handheld touchscreen device that connects to the Pod via Bluetooth Low Energy (BLE) and serves as the user interface of the system.

In addition to programmed basal delivery and automated insulin delivery, the Omnipod 5 ACE Pump allows users to deliver bolus doses at values that are either inputted manually or calculated by the Omnipod 5 Bolus Calculator based on the user's settings and userentered parameters. The Pod has the ability to connect to a compatible iCGM through BLE and receive data for use with the Omnipod 5 iAGC and Omnipod 5 Bolus Calculator.

AI/ML Overview

The Omnipod 5 ACE Pump is intended for the subcutaneous delivery of insulin and is stated to be substantially equivalent to the Omnipod DASH Insulin Management System with Interoperable Technology.

Acceptance Criteria and Reported Device Performance

The provided text primarily focuses on regulatory compliance and substantial equivalence to a predicate device rather than precise acceptance criteria and their corresponding empirical results in a clear tabular format. However, the document does mention performance aspects, particularly regarding Delivery Accuracy and Occlusion Detection.

Based on the available information, the following can be inferred:

Acceptance Criteria	Reported Device Performance	Study Type/Context
Delivery Accuracy	Basal: ± 5% at rates ≥ 0.05 U/hr	Performance Testing (tested per IEC 60601-2-24)
	Bolus: ± 5% for all set values ≥ 1.0 unit, ± 0.05 unit for set values < 1.0 unit	Performance Testing (tested per IEC 60601-2-24)
Occlusion Detection	Detects occlusion at 5.0 units.	Performance Testing

The document also mentions compliance with various standards, which implicitly sets acceptance criteria for aspects like software validation, risk management, human factors, and cybersecurity. However, specific quantitative acceptance values for these broader categories are not detailed in the provided text.

Study Information

Sample size used for the test set and the data provenance:
The document does not specify the sample sizes (number of devices, test conditions, etc.) used for the performance tests (e.g., delivery accuracy, occlusion detection). It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily lab-based performance verification rather than clinical data from human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The performance data presented (e.g., delivery accuracy, occlusion detection) would typically be derived from objective measurements against known standards rather than expert-established ground truth in a diagnostic context.
Adjudication method for the test set:
Not applicable, as the performance tests are quantitative measurements against defined specifications.
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:
Not applicable. The Omnipod 5 ACE Pump is an insulin infusion pump, not an AI-assisted diagnostic imaging device that would typically involve a multi-reader multi-case study. The focus is on the device's functional performance and safety.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself (the Pod) performs autonomously in its defined functions (e.g., insulin delivery, occlusion detection) based on its pre-programmed software and commands. Therefore, the "Performance Testing" data can be considered standalone algorithm performance for specific functionalities. However, the system is designed to be used with a human-in-the-loop (the user managing their diabetes) and interfaces with an automated insulin dosing software (iAGC). The document indicates "software verification and validation testing" was performed, which would cover the device's algorithmic performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For Delivery Accuracy and Occlusion Detection, the ground truth would be based on objective physical measurements against established engineering and medical device standards (e.g., volumetric measurements for insulin delivery, controlled pressure or flow scenarios for occlusion detection). This is not expert consensus, pathology, or outcomes data.
The sample size for the training set:
Not applicable. The document describes a medical device, an insulin pump, which is not an AI/ML model that learns from a training set in the typical sense. Its software is developed and validated through traditional software engineering processes, not machine learning training.
How the ground truth for the training set was established:
Not applicable, as there is no mention of a machine learning training set.

Ask a Question

Ask a specific question about this device

Page 1 of 1