(20 days)
The Disetronic D-TRON 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, as well as adhere to a proper diet and exercise regiment. 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 D-TRON Insulin Infusion Pump is an ambulatory, battery operated pump that administers small quantities of insulin to the patient. It is compact, watertight and shock resistant to maximize patient convenience. The total system consists of the pump and custom reservoir kit. The 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 stepper motor driving a rubber piston forward into the cartridge. The frequency of the motor revolution is controlled by the microprocessor according to the information programmed by the user or their care provider. The rate of the basal infusion each hour for twenty-four hours, subsequent boluses and any temporary increase or reduction in the basal rate can be simply entered using the four 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. Two separate 24-hour profiles for the delivery of insulin can be programmed independently for each hour of the day. The hourly dose can be incremented to a maximum of 25 I.U. per hour. The basal delivery can be supplemented by a bolus up to 25 I.U. Four push buttons on the pump let the patient manage the pump's functions and access current and historical information. The data entered or information accessed is displayed on a Liquid Crystal Display (LCD) and all actions are audibly confirmed. For safety and convenience, the user enters data in insulin units, eliminating the need to convert units to volume. The pump is designed with a comprehensive set of safety systems, alarms and alerts. When the pump senses any of the specified conditions it notifies the user with an intermittent beep (and/or vibration) and a visual display of the fault. The audible alarm can be canceled by pressing a button acknowledgment of the fault condition. The indication remains on the LCD until the fault is eliminated. The pump housing is made of impact resistant plastic. All screw connections and buttons are sealed making the pump watertight per IEC standards.
The provided text describes a 510(k) submission for the Disetronic D-TRON Insulin Infusion Pump, asserting its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria or a study detailing device performance against such criteria.
Instead, it focuses on demonstrating substantial equivalence based on:
- Functional comparison and design equivalency to a predicate device (Disetronic H-TRON Plus V100 Insulin Infusion Pump, K973044).
- Adherence to international safety and quality standards (IEC 60601-2-24, IEC 60601-1, IEC 60601-1-2).
- Compliance with software development procedures and Good Quality Assurance procedures.
Therefore, most of the requested information regarding acceptance criteria, reported performance, sample sizes, expert involvement, and ground truth cannot be extracted from this document.
Here's a breakdown of what can be answered (or why it cannot be answered) based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. The document states the device was "designed in accordance with IEC 60601-2-24" which "incorporates the requirements of IEC 60601-1 for all general safety requirements and 60601-1-2 for Electromagnetic Compatibility - Requirements and Tests." It also states "the specifications fully address pump performance." | Not specified in the document, as no specific performance data is presented. The document asserts that "functional comparison, design equivalency and the functional and safety testing" led to the conclusion of substantial equivalence. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The text mentions "functional and safety testing" but does not detail the methodology, sample size, or data provenance of such testing.
3. 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)
This information is not provided in the document. The document refers to engineering specifications and international standards, but not a clinical study involving expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
This information is not provided in the document. This device is an insulin infusion pump, not an AI-assisted diagnostic tool, so an MRMC study related to human readers and AI assistance would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device is a physical pump with software controlling its operation; performance evaluation would typically involve direct device testing, not standalone algorithm performance in the way this question implies for AI systems.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the document. The "ground truth" for this type of device would typically be defined by engineering specifications and metrological standards for pump accuracy and safety features, rather than clinical outcomes or pathology.
8. The sample size for the training set
This information is not provided in the document. As this is not an AI/machine learning model submission, a "training set" in that context would not be applicable.
9. How the ground truth for the training set was established
This information is not provided in the document. (See point 8).
§ 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).