(193 days)
The Aviator Insulin Pump is indicated for continuous delivery of insulin, at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin.
The Aviator insulin pump is a microprocessor controlled, battery powered, insulin pump system. The pump continuously delivers insulin according to an individualized software plan. A proprietary, disposable syringe is used as the insulin reservoir. The other component of the system is a disposable infusion set. There are two modes of delivery: basal and bolus. Basal delivery is a continuous infusion providing insulin the body needs to maintain target blood glucose levels under fasting conditions. To conserve power, basal delivery occurs in discrete pulses that are spaced nominally three minutes apart.
The provided text does not contain detailed acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical or performance study report. Instead, it describes a 510(k) submission for the Aviator Insulin Pump, focusing on substantial equivalence to a predicate device.
Here's an analysis based on the information provided, addressing the requested points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. It states in general terms:
- Acceptance Criteria Mentioned (Implicit): Requirements stated in the "specification documents."
- Reported Device Performance:
- "Bench testing and software validation verified the requirements stated in the specification documents."
- "A Human Factors Study was conducted to validate the overall design of the Aviator insulin pump in the hands of the user."
- "Environmental testing includes testing for electromagnetic compatibility."
- "The performance data demonstrates substantial equivalence between the Aviator infusion pump and the Abbott Diabetes Care infusion pump."
Without specific numerical targets for flow rate accuracy, delivery precision, or safety features, an acceptance criteria table cannot be constructed from this document. The focus is on demonstrating equivalence through these tests, rather than meeting novel performance thresholds.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified for bench testing, software validation, or environmental testing.
- Data Provenance: Implied to be prospective as these are tests conducted as part of the device development and submission process. The country of origin is not explicitly stated, but given "Abbott Diabetes Care Inc." and the submission to the FDA (USA), it's likely primarily US-based or international studies conducted for US regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided as the disclosed "performance data" refers to bench tests and software validation, not clinical studies requiring expert ground truth for interpretation of outputs like images or diagnoses.
- A "Human Factors Study" was conducted, which would involve users, but the specifics of expert involvement or ground truth establishment are not detailed.
4. Adjudication method for the test set
- This information is not provided. Adjudication methods are typically relevant for clinical studies involving multiple observers, particularly for subjective assessments. The nature of the performance data (bench testing, software validation) does not typically involve such adjudication.
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 MRMC comparative effectiveness study is mentioned. This device is an insulin pump, not an AI diagnostic tool that assists human readers/interpreters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This concept is not directly applicable to an insulin pump in the same way it would be for a diagnostic algorithm. The pump is a standalone device in its function of delivering insulin, but it requires human interaction (e.g., setting parameters, bolusing). The described "Human Factors Study" assesses the overall design "in the hands of the user," indicating a human-in-the-loop evaluation rather than a purely standalone algorithm assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the bench testing and software validation, the "ground truth" would be the engineering specifications and design requirements. The device performance is compared against these predetermined, objective standards.
- For the Human Factors Study, the "ground truth" would likely relate to usability metrics, user satisfaction, and successful execution of tasks according to predefined criteria, but the specific details are not provided.
8. The sample size for the training set
- This information is not applicable as the document describes an insulin pump, which is a hardware and software system, not a machine learning model that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- This information is not applicable for the same reason as point 8.
Summary based on available information:
The document describes the regulatory submission for an insulin pump, emphasizing substantial equivalence to a predicate device. The "performance data" section outlines various types of engineering and usability testing (bench testing, software validation, human factors, environmental testing), but it does not provide detailed quantitative acceptance criteria or specific study designs (like sample sizes or ground truth establishment methods for clinical evaluations) which would typically be found in reports for AI/diagnostic devices. The focus is on verifying compliance with specifications and demonstrating equivalence rather than presenting novel performance metrics against a clinical ground truth.
§ 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).