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The Medtronic MiniMed Paradigm Model MMT-515/715 Insulin Pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The Paradigm Model 515 and 715 are external, portable insulin pumps, designed for continuous delivery of insulin. They are designed to deliver 0.00 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insulin per meal bolus. The difference between the MMT-515 and 715 pumps is the reservoir size. The MMT-515 will be compatible with a 1.5 ml reservoir and MMT-715 can be used with both the 3.0 and the 1.5 ml reservoirs.

This 510(k) summary for the Medtronic MiniMed Paradigm Model 515 and 715 Insulin Pumps does not contain the detailed information required to fill out all requested sections regarding acceptance criteria and a definitive study proving the device meets them.

The document primarily focuses on:

• Identifying the device and its predicate.
• Describing its intended use and basic functionality.
• Stating that the device has "similar materials and basic design" to the predicate and includes "hardware as well as software modifications including the Bolus Wizard upgrades and other user improvements."
• Concluding with a substantial equivalence determination by the FDA.

There is no mention of specific acceptance criteria, performance metrics, a dedicated study, sample sizes, expert involvement, or any form of ground truth establishment. This type of information is usually found in a separate section detailing performance data, often titled "Performance Data" or "Non-Clinical and Clinical Tests."

Therefore, I have to state that the requested information is largely not available in the provided document.

However, I can extract the available information and indicate what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified in the document.
• Data Provenance: Not specified in the document. (e.g., country of origin, retrospective/prospective)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not specified in the document.
• Qualifications of Experts: Not specified in the document.

4. Adjudication method for the test set

• Not specified in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not mentioned. This device is an insulin pump, not an AI-assisted diagnostic tool involving human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable in the typical sense for this type of medical device where "standalone performance" usually refers to the device's functional operation (e.g., pumping accuracy, alarm activation). While the device operates "standalone," specific performance metrics from such a test are not detailed in this summary.

7. The type of ground truth used

• Not specified in the document. For an insulin pump, ground truth would typically relate to the accuracy of insulin delivery against a calibrated standard, the reliability of its components, and its safety features' performance.

8. The sample size for the training set

• Not specified in the document. (If any software modifications involved machine learning, this would be relevant, but it's not clear from the text that AI/ML was used, and no training data is mentioned).

9. How the ground truth for the training set was established

• Not specified in the document.

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