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The Medtronic MiniMed Paradigm Model 712E Insulin Pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.

The Paradigm Model MMT-712E is an external, portable insulin pump, designed for continuous delivery of insulin. It is designed to deliver 000 to 35.00 units of U100 insulin per hour in basal rates and up to 25.00 units of U100 insults per meal bolus. The insulin programming step size allows users to program insulin delivery in steps of 0.1 units for boluses and 0.05 units/hour for basal dclivery. The Model 712F accommodates a proprietary 3.0 ml reservoir. This reservoir mates with the existing and future Paradigm infusion sets.

The provided text is a 510(k) summary for the Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump. This document is primarily focused on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving device performance against those criteria in the way one might expect for a novel AI/software device.

Based on the provided text, there is no information available regarding acceptance criteria, device performance metrics, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance studies, or ground truth details relevant to an AI/software device.

The 510(k) summary explicitly states:

• "The new and predicate devices have identical materials and design. The new device, MMT 712E, is a derivative of the MMT-712. Both pumps are mechanically identical. Software modifications only were made to the MMT-712E to disable certain features thereby simplifying its use."

This indicates that the device is a modified version of an existing, already cleared device, with software modifications solely to simplify its use by disabling certain features. Therefore, the primary "study" proving its acceptance would have been focused on demonstrating that these software changes did not introduce new safety or effectiveness concerns, and that the simplified device still performed its intended function within the expected parameters of the predicate device. This is a much different type of evaluation than what is typically performed for AI/ML-driven diagnostics or decision support systems.

Given this context, I cannot fulfill the request as presented, because the necessary information is not within the provided text. The questions posed are targeted at the evaluation of AI/ML-driven devices, which is not what the Medtronic MiniMed Paradigm Model MMT-712E Insulin Pump represents based on this 510(k) summary.

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The Medtronic MiniMed Paradigm Model 712 Insulin Pump is 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 712 is an external, portable insulin pump, designed for continuous delivery of insulin. It is 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. This pump will include a bolus estimator feature that can be tailored to an individual user's insulin sensitivity, insulin to carbohydrate ratio, and target BG (Blood Glucose). Also, there is a BG reminder feature, allowing the user to set daily and post-bolus reminders to check BG readings. The insulin programming step size will allow users to program insulin delivery in steps of 0.1 units for boluses and 0.05 units for basal delivery. The Model 712 accommodates a proprietary 3.0 ml reservoir. This new reservoir mates with the existing and future Paradigm infusion sets.

The provided text is a 510(k) premarket notification for the Medtronic MiniMed Paradigm Model 712 Insulin Pump. It establishes substantial equivalence to a predicate device (Medtronic MiniMed Paradigm Model 511 Insulin Pump) rather than presenting a standalone study with acceptance criteria and performance data.

Therefore, the document does not contain the acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

Specifically, the following information is not available in the provided text:

• A table of acceptance criteria and the reported device performance: The document discusses the device's features, but not specific performance metrics against predefined acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set or data provenance details are mentioned.
• Number of experts used to establish the ground truth for the test set and their qualifications: No information regarding ground truth establishment or experts is present.
• Adjudication method: Not applicable as no test set evaluation is described.
• Multi reader multi case (MRMC) comparative effectiveness study: This type of study is not mentioned.
• Standalone (i.e. algorithm only without human-in-the loop performance) was done: Not described.
• The type of ground truth used: No ground truth is discussed.
• The sample size for the training set: No training set is mentioned.
• How the ground truth for the training set was established: Not applicable as no training set ground truth is discussed.

The document focuses on:

• Device Name: Medtronic MiniMed Paradigm Model 712 Insulin Pump
• Indications for Use: Continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
• Predicate Device: Medtronic MiniMed Paradigm Model 511 Insulin Pump
• Key Differences from Predicate: Larger case, software modifications including a Bolus Wizard feature (which assists users in calculating insulin boluses based on personalized settings like insulin sensitivity, insulin to carbohydrate ratio, and target blood glucose), and a 3.0 ml reservoir.
• Insulin Programming Step Size: 0.1 units for boluses and 0.05 units for basal delivery.

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