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1. The Medtronic Marinr catheter is intended for use in diagnostic electrophysiologic procedures. The Medtronic Marinr catheter is designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

2. The Medtronic StableMapr catheter is intended for use in diagnostic electrophysiologic procedures. These catheters are designed for recording intracardiac electrograms and temporary pacing associated with electrophysiology studies.

Medtronic diagnostic catheters are flexible radiopaque catheters constructed of extruded polymer over a stainless-steel braid. The catheters contain platinum-iridium sensing band electrodes and are designed for intracardiac recording or stimulation.

This premarket notification covers changes impacting Medtronic diagnostic catheters, including labeling updates, packaging design and packaging material changes, and product requirement updates.

This document is a 510(k) premarket notification review for a medical device. It does not contain information about studies involving AI or human reader performance. The document describes changes to existing devices (Marinr and StableMapr Steerable Intracardiac Electrode Catheters) and demonstrates substantial equivalence to predicate devices through a series of performance (bench) and packaging tests.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set sample size, ground truth for training set) are not applicable as this document does not describe a study involving an AI algorithm that produces diagnostic outputs requiring such analyses.

Here's the available information based on the provided text:

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

The document lists "product requirement changes" and "product requirement testing," implying that the tests performed served as acceptance criteria. However, explicit numerical acceptance criteria values are not provided within this document. Instead, the document states: "The results of the design verification testing completed in support of the proposed changes demonstrate that the diagnostic catheters in scope of this premarket notification meet all applicable proposed product requirements."

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

The document mentions "test samples exposed to accelerated aging conditions equivalent to the product shelf life of 2 years" for product requirement testing. However, the specific sample sizes for each test are not provided. Data provenance (country of origin, retrospective/prospective) is not applicable as these are bench tests on manufactured products.

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. This is a bench testing study for substantial equivalence of physical medical devices, not a diagnostic study requiring expert ground truth or a human-in-the-loop performance evaluation.

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

Not applicable. This is a bench testing study.

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

No such study was done. This document pertains to the physical and packaging characteristics of diagnostic catheters, not an AI-assisted diagnostic system.

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

Not applicable. This document is not about an algorithm.

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

The "ground truth" for the performance tests would be the established engineering and materials specifications and accepted standards for medical device performance. For packaging, it would be packaging integrity and labeling standards.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning study.

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

Not applicable. This is not an AI/machine learning study.

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