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The Disetronic H-TRONplus Insulin Infusion Pump is intended for the controlled delivery of insulin as prescribed by a physician.

It is indicated for patients with insulin dependent Diabetes Mellitus who do not have optimum blood glucose control on conventional insulin injection therapy. Patients for insulin pump therapy must be highly motivated to perform self-glucose monitoring on a frequent and regular basis. They must be able to adjust their insulin supply to varying needs depending on actual blood glucose levels, planned meals, physical activities, etc. Patients must be capable of operating the pump. They must also have access to the educational training, support, and follow-up of health care professional experienced in insulin pump therapy.

The Disetronic H-TRONplus Insulin Infusion Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, shock resistant and has easy to feel buttons to maximize patient convenience. The pump housing is made of impact resistant plastic. The total system consists of the pump, piston rod, cartridge and adapter. The H-TRONplus Insulin Infusion Pump is compatible with commercially available subcutaneous administration sets with standard female luer connectors.

Insulin delivery is accomplished through the reservoir piston mechanism. The piston is advanced by means of a DC motor driving a rubber stopper forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or his or her health care provider. The rate of the hourly basal infusion for twenty-four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the three buttons on the pump. Additionally, the user controls infusion start, infusion stop and has access to information important to proper monitoring of the pump and the therapy directly on the pump.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. The submission focuses on the device's compliance with established standards rather than a clinical or performance study with a specific test set.

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

This information is not provided in the document. As noted above, the submission refers to design and testing against standards, not a ground truth clinical evaluation.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted or reported in this document. The submission pertains to the substantial equivalence of an updated medical device to a predicate device based on technical standards, not a comparative study with human readers or AI assistance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance Study

A standalone performance study of an algorithm was not conducted or reported in this document. This device is a mechanical/electronic insulin infusion pump, not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" in this context refers to compliance with international safety and performance standards (IEC 60601-2-24, IEC 60601-1, IEC 60601-1-2) rather than clinical outcomes or pathology data. The device was designed and tested to meet these established engineering and safety specifications.

8. Sample Size for the Training Set

This information is not applicable and not provided. This is an insulin pump, not a machine learning algorithm that requires a training set.

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

This information is not applicable and not provided.

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