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MiniMed Reservoir- This Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for compatibility.

Extended Reservoir- The Extended Reservoir is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.

The MiniMed family of reservoirs (MMT-326A, MMT-342, MMT-342, MMT-342G) (herein referred to as "reservoirs" or "subject devices") are sterile medication containers designed for single use. The reservoirs are a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring the subcutaneous administration of insulin to maintain acceptable blood glucose levels. The reservoirs are indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps (i.e., Paradigm pumps and NGP pumps) and infusion sets. Refer to the Medtronic insulin pump user guide for a list of compatible insulins and infusion sets. The reservoirs have the same principle of operation as the predicate devices (MMT-326A, MMT-332A, MMT-342, MMT-342G) and are designed to mechanically connect to compatible infusion sets. Reservoirs are connected to the infusion set via the tubing connector (H-Cap), which enables insulin infusion from the reservoir through a fluid path into the subcutaneous tissue.

This document describes a 510(k) premarket notification for Medtronic MiniMed's Extended Reservoir and MiniMed Reservoir. The purpose of the submission is to qualify an additional sterilization site and an optimized ethylene oxide (EO) sterilization cycle for these devices.

Here's an analysis of the provided text in response to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that "The test results demonstrate the subject devices met all the product requirements and specifications of the predicate devices." and "Medtronic concludes the reservoirs can be sterilized at the additional facility using the optimized parameters for EO sterilization cycle."

The acceptance criteria are implicitly defined by the product requirements and specifications of the predicate devices. The performance reported is that the subject devices met these predicate device requirements/specifications.

The relevant performance data from the text is summarized as follows:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document states: "The testing was performed on MMT-332A since the subject devices have the same hardware design, materials, and attributes as the predicate device."

• Sample Size: The document does not specify the exact sample size (number of units) used for the verification testing. It only mentions that the testing was performed on "MMT-332A" (a 3.0mL MiniMed Reservoir).
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given that it's "verification testing," it would typically be prospective data generated by Medtronic as part of the submission process. Medtronic MiniMed is located in Northridge, CA, USA, and the contract manufacturer and one sterilization site are in Puerto Rico, so the data likely originated from these locations.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable to this submission. The device is an infusion pump accessory, and the testing focuses on the impact of a sterilization process change on the device's physical, chemical, and functional attributes, as well as its sterility. It does not involve human interpretation or diagnostic performance where experts establish a "ground truth" in the diagnostic sense. The "ground truth" here is the established product requirements and specifications of the predicate devices.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or diagnostic results, where multiple experts provide opinions that may need to be reconciled to establish a ground truth. The testing described here is engineering and sterilization validation, which does not involve such an adjudication process.

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

This is not applicable. An MRMC study is relevant for AI-powered diagnostic or screening devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. The Medtronic reservoirs are physical medical devices, and the submission is about a sterilization process change, not an AI diagnostic tool.

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

This is not applicable. The device is not an algorithm or software. It is a physical medical device (reservoir) for insulin delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this submission is the established product requirements and specifications of the predicate devices (MiniMed Reservoir 1.8mL (MMT-326A), MiniMed Reservoir 3.0mL (MMT-332A), and Extended Reservoir (MMT-342, MMT-342G)). The verification testing aimed to demonstrate that the subject devices, after the sterilization change, still meet these existing, validated performance standards.

8. The sample size for the training set

This is not applicable. This is not a machine learning or AI device that requires a training set. The submission concerns changes to a manufacturing process (sterilization) for an existing medical device.

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

This is not applicable, as there is no training set for this type of device submission.

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The Extended Reservoir is indicated for the subcutaneous infusion including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.

Extended Reservoir (herein referred to as "EWR" or "MMT-342") is a sterile medication container designed for single use. The Extended Reservoir (MMT-342) is a component of the Medtronic Insulin Pump Delivery System used by patients with diabetes mellitus, requiring subcutaneous administered insulin, to maintain acceptable blood glucose levels. The Extended Reservoir (subject device) is indicated for the subcutaneous infusion of medication, including insulin, from compatible Medtronic insulin pumps and infusion sets. Refer to your Medtronic insulin pump user guide for a list of compatible insulins and infusion sets.

The provided text describes a 510(k) premarket notification for an "Extended Reservoir" (MMT-342) by Medtronic MiniMed, Inc. The primary purpose of this notification is to demonstrate substantial equivalence to a predicate device (Medtronic MiniMed Paradigm Reservoir MMT-332A, K032005) while extending the duration of use from 3 days to 7 days.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion is to demonstrate that extending the duration of use for the reservoir from 3 days to 7 days does not negatively impact the safety and effectiveness of the device. Since there are no changes in hardware design, materials, manufacturing, packaging, sterilization processes, fluid capacity, insulin compatibility, or reservoir assembly, the acceptance criteria are implicitly tied to maintaining the performance characteristics of the predicate device over the extended duration.

The text does not provide a specific table of quantitative acceptance criteria for parameters like insulin delivery accuracy, occlusion detection, or material degradation. Instead, it states that "The test results demonstrate that MMT-342 (subject device) met all the product requirements and specifications of MMT-332A (predicate device)." This implies that the performance over 7 days matches the established performance standards of the 3-day predicate.

The reported device performance, in summary, is that the Extended Reservoir (MMT-342) successfully maintains the same safety and effectiveness as the predicate device (MMT-332A) when used for up to 7 days.

Study Details

1. Sample size used for the test set and the data provenance:
   The document states: "Medtronic performed verification testing to support extending the duration of the reservoirs use (from up to 3 days to up to 7 days)." However, the specific sample size for this verification testing is not provided in the extracted text.
   The provenance of the data is not explicitly mentioned (e.g., country of origin, retrospective/prospective). It is implied to be internal testing conducted by Medtronic.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the extracted text. The verification testing described is likely technical performance testing rather than human expert assessment of a medical condition.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   This information is not applicable as the document describes technical verification testing, not a clinical study involving adjudication of clinical observations.

4. 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:
   This information is not applicable. The device is an insulin reservoir, not an AI-assisted diagnostic tool.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   This information is not applicable. The device is a physical medical device (insulin reservoir), not a software algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
   For mechanical/material performance, the "ground truth" would be established engineering specifications and validated test methods (e.g., for infusion accuracy, material integrity, sterility maintenance). The document indicates that the subject device "met all the product requirements and specifications of MMT-332A." This implies the predicate device's established performance standards serve as the ground truth.

7. The sample size for the training set:
   This information is not applicable as the device is a physical medical device, not a machine learning model.

8. How the ground truth for the training set was established:
   This information is not applicable for the same reason as above.

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