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The Omnipod GO Insulin Delivery Device is intended for the subcutaneous infusion of insulin at a preset basal rate in one 24-hour time period for 3 days (72 hours) in adults with type 2 diabetes.

The Omnipod GO Pod helps manage diabetes by providing continuous subcutaneous insulin delivery. To facilitate insulin dose titration and provide appropriate options across a wide range of daily insulin needs, the Omnipod GO Device will come in seven different models: 10, 15, 20, 25, 30, 35, and 40 units per day, with each model delivering insulin at a fixed rate over the 72hour life of the device. There is no ability to deliver a bolus dose of insulin using the Omnipod GO device. Like the proposed predicate device (V-GO Insulin Delivery System, K103825), Omnipod GO will be entirely self-contained in an on-body device that is single-use, sterile, and disposable. It is small, lightweight, and designed to the body via an adhesive pad. The adhesive backing keeps the device securely in place for up to 3 days (72 hours).

The provided text describes the Omnipod GO Insulin Delivery Device, but it does not contain specific acceptance criteria or the study details to prove the device meets those criteria, especially in the format of a table with reported device performance.

Here's what can be extracted from the document regarding performance and evaluation, and where information is missing:

Missing Information:

• Specific Acceptance Criteria Table: The document doesn't provide a table explicitly listing acceptance criteria for performance metrics (e.g., specific accuracy ranges they aimed for). It mentions "predetermined acceptance criteria were met" but doesn't detail what they were.
• Reported Device Performance: While it states the device delivers insulin accurately and detects occlusions, specific numerical performance results (e.g., X% accuracy, occlusion detection time) are not provided in the summary.
• Test Set Sample Size: The document refers to "human factors validation" and "performance testing" but does not specify the sample size used for these tests.
• Data Provenance (Test Set): Not explicitly stated whether the test data was retrospective or prospective, or its country of origin.
• Number of Experts & Qualifications (for Ground Truth): Not mentioned for any ground truth establishment.
• Adjudication Method: Not mentioned.
• MRMC Comparative Effectiveness Study: Not mentioned as being performed.
• Effect Size of Human Readers Improvement with AI: Not applicable as no MRMC study with AI assistance is mentioned.
• Standalone (Algorithm Only) Performance: The device is an insulin delivery device, not an AI diagnostic/screening algorithm, so this concept (algorithm only performance) doesn't directly apply in the typical sense for medical imaging or similar devices. Its performance is inherent to its physical operation.
• Type of Ground Truth Used: For mechanical performance, "ground truth" would implicitly be highly accurate measurements against known standards. For human factors, it would be based on participant observations and feedback. However, it's not explicitly detailed.
• Training Set Sample Size: Not applicable/not mentioned, as there is no mention of a machine learning model being "trained" in the typical sense for this device.
• How Ground Truth for Training Set was Established: Not applicable/not mentioned.

What is provided in the document:

The document outlines a series of non-clinical performance data categories and general statements about compliance and effectiveness.

Summary of Non-Clinical Performance Data (What was done, but not detailed results or acceptance criteria):

• Risk Management: Completed in accordance with ISO14971:2019. "Verification activities... demonstrated that the predetermined acceptance criteria were met." (Details of criteria and results are missing).
• Safety Assurance: Device utilizes an insulin pump design marketed with other Omnipod devices. Risk mitigations from previous devices are similarly implemented to provide safety against overdose and underdose (occlusion detection, delivery accuracy).
• Human Factors Validation: Followed IEC 62366:2015-1, HE75:2009, and FDA guidance. "A robust validation evaluation was performed to demonstrate safe and effective use... Results... demonstrate that the Omnipod GO has been found to be safe and effective." (Specific data, sample size, or acceptance criteria are missing).
• Software Validation: Performed in accordance with IEC 62304:2015 and FDA guidance.
• Cybersecurity: Analysis performed following FDA guidance.
• Performance Testing: "Demonstrated that the device delivers insulin accurately at various flow rates and that it can effectively detect when an occlusion occurs and promptly notify the user." (Specific metrics, acceptance criteria, and results are missing).
• Biocompatibility: Evaluation performed per ISO 10993-1:2018 (patient-contacting materials are the same as currently marketed Omnipod Pod devices).
• Sterilization: Product adoption completed into the family of devices under sterilization validation.
• Electrical Safety and EMC Testing: Performed to verify compliance with IEC 60601-1:2005 and IEC 60601-1-2.

Key Performance Claim related to Predicate Device Comparison (Table 1.01):

This is the only specific quantitative performance metric with a value mentioned in the entire document. The document implies this "improved" accuracy value meets the new device's acceptance criterion for insulin delivery accuracy.

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