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The MiniMed insulin pump, model 508, is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The 508 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 508 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 principal modifications described in this submission are intended to allow the pump user more options for programming, and to enhance the convenience of the device.

Convenience features include a vibrating and escalating audible alarm; a low insulin alert; new keypad; and a new LCD screen. New programming features include the addition of two personal delivery patterns to enhance delivery options; the ability to program a bolus on square wave to enable the user to program a bolus while an extended (or square wave) bolus is being administered; child block to help prevent reprogramming by younger users; and limited remote programming by radio frequency (RF), which allows users to deliver an audio bolus, suspend or restart the pump.

The new device also has a flash memory instead of a read only memory, which holds data in the pump batteries are removed for more than two hours.

The provided document is a 510(k) summary for the MiniMed Model 508 Insulin Pump. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document primarily focuses on:

• Device Description: What the MiniMed Model 508 Insulin Pump is and its key features.
• Intended Use: For whom and how the device is meant to be used (continuous delivery of insulin for diabetes management).
• Predicate Device: Its predecessor, the MiniMed Model 507C Insulin Pump.
• Substantial Equivalence: An assertion that the new device does not differ significantly in technological features from the predicate device and has similar materials, product design, and energy source.
• FDA Clearance Letter: The official FDA letter stating that the device is substantially equivalent to legally marketed devices and can be marketed.
• Indications for Use Form: A standard form confirming the indications for use.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details because that information is not present in the provided text.

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