(115 days)
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.
| Acceptance Criterion Category | Reported Device Performance |
|---|---|
| Physical Characteristics | Met acceptance criteria. |
| Drop and Vibration | Successfully met all relevant requirements per IEC 60601-2-24. |
| Software | Documentation prepared and submitted for a MAJOR level of concern device in accordance with FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, meeting acceptance criteria. |
| Electrical Safety | Successfully passed all relevant sections of IEC 60601-1 Medical electrical equipment, General requirements for Safety. |
| RF Wireless Safety and Performance | Tested and verified to ensure proper wireless communication between the Pod and PDM, meeting acceptance criteria. |
| Electromagnetic Interference | Successfully met all relevant sections (Radiated emissions, Electrostatic discharge test, radiated radio frequency immunity electromagnetic field immunity, and Power frequency magnetic field immunity test) to satisfy compliance. |
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.
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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.
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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.
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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.
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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).
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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.
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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).
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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."
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How the ground truth for the training set was established
- Not applicable, as there was no training set for an AI algorithm.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).