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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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