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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.

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