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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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MiniMed Connect is intended to provide a secondary display of continuous glucose monitoring and/or insulin pump data on a suitable consumer electronic device to care partners and users of a MiniMed 530G system or Paradigm REAL-Time Revel system for the purpose of passive monitoring.

MiniMed Connect system is not intended to replace the real-time display of continuous glucose monitoring and/or insulin pump data on the primary display device (i.e. the sensor-augmented pump). All therapy decisions should be based on blood glucose measurements obtained from a blood glucose meter.

The MiniMed Connect is not intended to analyze or modify the continuous glucose monitor data and/or insulin pump data that it receives. Nor is it intended to control any function of the connecting continuous glucose monitor system and/or insulin pump. The MiniMed Connect is not intended to serve as a replacement for a primary display device for the continuous glucose monitoring system and/or insulin pump data. The MiniMed Connect is not intended to receive information directly from the sensor or transmitter of a continuous glucose monitoring system.

MiniMed® Connect is a secondary display of continuous glucose monitor and/or insulin pump data on a suitable consumer electronic device for insulin pump patients and their care partners. This system is designed as an optional accessory to compatible sensor-augmented pump systems.

MiniMed® Connect consists of a MiniMed® Connect app (for a local secondary display), the CareLink® Connect module of CareLink® Personal (for a remote secondary display), and the MiniMed® Connect uploader (for data transmission to the local app).

The MiniMed® Connect uploader is a small, battery-powered, ambulatory device that is carried with the patient in near proximity to the insulin pump. Its rechargeable battery is charged as needed (approximately once a day) using a USB Charger that accompanies the device.

The MiniMed® Connect uploader receives continuous glucose monitor and/or insulin pump data from the sensor-augmented insulin pump using a proprietary 916.5 MHz RF, and then converts it into a 2.4 GHz Bluetooth Low Energy (BLE) format. This BLE formatted data can then be read by the MiniMed® Connect app installed on a compatible consumer electronics device with BLE capabilities.

The MiniMed® Connect app reads the BLE data transmission and displays it on the patient's compatible consumer electronic device. The MiniMed® Connect app then uploads the continuous glucose monitor and/or insulin pump data to CareLink® Connect, the remote monitoring module of CareLink® Personal. Authorized care partners can access CareLink® Connect to view the patient's continuous glucose monitor and/or insulin pump data through an Internet-enabled consumer electronic device for the purpose of passive monitoring.

Accessories associated with this system include:

• USB Charger (for charging the MiniMed® Connect uploader) .

I am sorry, but the provided text does not contain the specific information required to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) summary for the MiniMed Connect device, which primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, the text states under "PERFORMANCE DATA [807.92(b)] VII.":

"Results of the verification and validation testing indicate that the product meets established performance requirements, and is safe and effective for its intended use."

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about the sample size, data provenance, number of experts, their qualifications, or adjudication methods for a test set.
• Information about MRMC comparative effectiveness studies, effect sizes, or standalone algorithm performance.
• The type of ground truth used, training set sample size, or how ground truth for the training set was established.

The document confirms that verification and validation testing was done and that the device met performance requirements, but it does not elaborate on what those requirements were or present the results of such testing.

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The Medtronic CareLink™ USB Connector is indicated for use by patients at home and clinicians in a medical office setting to facilitate communication between Medtronic diabetes ther apy management devices that use Paradigm-compatible RF telemetry and a personal computer that uses data management application software.

The Medtronic MiniMed CareLink USB Connector is an accessory device that facilitates wireless communication between compatible Medtronic MiniMed radiofrequency telemetry devices and a personal computer. The hardware component of the CareLink USB Connector consists of a radio-frequency (RF) transceiver enclosed in a plastic housing and one USB connector that is compatible with a type A (female) USB port of a personal computer (PC) or a USB hub. The CareLink USB Connector has a form factor similar to a USB flash memory stick and will by recognized by the PC as a USB device. The CareLink USB Connector is designed for use with Medtronic MiniMed devices that use Paradigm radiofrequency telemetry. Data is transferred between Medtronic MiniMed Paradigm RF compatible devices and a personal computer (PC) using select Medtronic MiniMed data management software applications.

The provided text is related to a 510(k) premarket notification for the Medtronic MiniMed CareLink™ USB Connector (Model MMT-7305). This device is an accessory that facilitates wireless communication between Medtronic MiniMed radiofrequency telemetry devices and a personal computer. The 510(k) summary focuses on comparing this new device to a predicate device (Com-Link Communication System, Model MMT-7304) and asserting substantial equivalence.

Crucially, this document does not describe any performance acceptance criteria for the device itself, nor does it detail any study that proves the device meets such criteria in terms of clinical or diagnostic accuracy. The focus is on the device's technological features and its intended use as a communication facilitator, not on a diagnostic or therapeutic output that would require a performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or directly stated based on the given document:

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

No explicit acceptance criteria or reported device performance metrics (such as sensitivity, specificity, accuracy, etc.) are mentioned in the provided text. The submission is a 510(k) for substantial equivalence based on technological features and intended use, not clinical performance.

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

Not applicable. No performance study data is presented. The submission focuses on device design and comparison to a predicate.

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)

Not applicable. No ground truth establishment or expert review for a test set is mentioned.

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

Not applicable. No adjudication methods for a test set are mentioned.

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. This device is not an AI-assisted diagnostic tool, and no MRMC study or AI assistance is mentioned.

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

Not applicable. This device is a communication connector, not an algorithm with standalone performance.

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

Not applicable. No ground truth for performance evaluation is mentioned.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable. No ground truth for a training set is mentioned.

Summary:

The provided document is a regulatory submission (510(k)) focused on demonstrating substantial equivalence of a new medical device (a USB connector for data transfer) to an existing predicate device. The primary argument for equivalence is based on similar function and technology, with the main difference being the physical connection type (USB vs. serial port). This type of submission typically does not involve extensive clinical performance studies or the establishment of ground truth for diagnostic accuracy, as the device's function is data communication rather than a diagnostic or therapeutic intervention itself. Therefore, the requested information regarding acceptance criteria and performance studies is not present in the given text.

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