(78 days)
The Medtronic MiniMed Paradigm Model 712E Insulin Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The Paradigm Model MMT-712E is an external, portable insulin pump, designed for continuous delivery of insulin. It is designed to deliver 000 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insults per meal bolus. The insulin programming step size allows users to program insulin delivery in steps of 0.1 units for boluses and 0.05 units/hour for basal dclivery. The Model 712F accommodates a proprietary 3.0 ml reservoir. This reservoir mates with the existing and future Paradigm infusion sets.
The provided text is a 510(k) summary for the Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump. This document is primarily focused on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving device performance against those criteria in the way one might expect for a novel AI/software device.
Based on the provided text, there is no information available regarding acceptance criteria, device performance metrics, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance studies, or ground truth details relevant to an AI/software device.
The 510(k) summary explicitly states:
- "The new and predicate devices have identical materials and design. The new device, MMT 712E, is a derivative of the MMT-712. Both pumps are mechanically identical. Software modifications only were made to the MMT-712E to disable certain features thereby simplifying its use."
This indicates that the device is a modified version of an existing, already cleared device, with software modifications solely to simplify its use by disabling certain features. Therefore, the primary "study" proving its acceptance would have been focused on demonstrating that these software changes did not introduce new safety or effectiveness concerns, and that the simplified device still performed its intended function within the expected parameters of the predicate device. This is a much different type of evaluation than what is typically performed for AI/ML-driven diagnostics or decision support systems.
Given this context, I cannot fulfill the request as presented, because the necessary information is not within the provided text. The questions posed are targeted at the evaluation of AI/ML-driven devices, which is not what the Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump represents based on this 510(k) summary.
§ 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).