(119 days)
The MMT-507 is intended for continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The MMT-507 external insulin pump is a rate-programmable syringe infusion pump, designed for continuous delivery of insulin, at set and variable rates, as prescribed by the user's physician. The MMT-507 is restricted to sale by or on the order of a physician. It is not intended or indicated for the delivery of blood or blood products.
The MMT-507 consists of an external case, a microprocessor, a Liquid Crystal Display (LCD), a syringe compartment with a lead screw connecting to a motor. None of these components contact the fluid pathway.
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is a 510(k) Summary for the MiniMed MMT-507 (Insulin Infusion Pump), which focuses on comparing the new device to a predicate device (MiniMed MMT-506) and outlining its technological features and intended use for regulatory submission purposes.
The document does not contain any details regarding:
- A table of acceptance criteria.
- Reported device performance against specific criteria.
- Sample sizes for test sets or data provenance.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets.
- How ground truth for training sets was established.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them using only the provided input.
§ 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).