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The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting in programming insulin basal delivery patterns, insulin delivery rates and current basal rates in effect on the pump. It is intended to communicate with devices that utilize Paradigm pump compatible RF telemetry (i.e. MMT-512).
The Medtronic MiniMed ParadigmPAL (model 7330) is intended for use by patients at home and clinicians in a medical office setting as a tool to save and adjust Medtronic MiniMed Paradigm pump settings using a personal computer.

The Medtronic MiniMed ParadigmPAL is data transfer software designated by Medtronic MiniMed to interface with hardware models 7304 (ComLink) and HS-3222 (Paradigm Link); personal computer and a Paradigm insulin infusion pump.
The ParadigmPAL system is designed for use with Medtronic MiniMed infusion pumps (model 512 and model 712).

The provided text is a 510(k) summary for the Medtronic MiniMed ParadigmPAL, model 7330, and related FDA correspondence. It does not contain information about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert involvement that would typically be found in a detailed study report. The document primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information based on the given text. The K031541 filing is a submission demonstrating equivalence rather than a study with performance metrics against pre-defined acceptance criteria.

To elaborate, the document states:

• Device Description: The ParadigmPAL is data transfer software designed to interface with specific hardware models, personal computers, and Paradigm insulin infusion pumps.
• Intended Use: For patients at home and clinicians in a medical office setting to "program insulin basal delivery patterns, insulin delivery rates and current basal rates in effect on the pump" and "communicate with devices that utilize Paradigm pump compatible RF telemetry."
• Comparison to Predicate: The key difference from the predicate device (Com-Link™ Communication System) is the ParadigmPAL's ability to "upload of information to the pump" in addition to downloading the information, which the predicate device could only do.
• FDA Determination: The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls.

This is a regulatory pathway that largely relies on demonstrating that the new device is as safe and effective as a legally marketed device, often without requiring new clinical performance studies if the technological characteristics and intended use are very similar.

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