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The Medtronic® Zuma™ Guiding Catheter is designed to provide a pathway through which therapeutic devices are introduced. The Zuma™ catheter is intended to be used in the coronary or peripheral vascular system.

The Medtronic® Zuma™ Guiding Catheters will be available in 5F 9F outer diameters. The 6F and 9F (non-segmented) catheter is constructed with a braided proximal shaft with an inner liner and a soft distal tip. The 5F, 7F, 8F and 9F(segmented) Zuma catheters are manufactured with a braided proximal shaft and segments, an inner liner and a soft distal tip. The inner lumen of the Zuma™ catheter has a thin lubricious coating. The Zuma™ Guiding Catheter (6F - 9F) has a larger inner lumen diameter than its predicate devices. The 5F Zuma is comparable in stiffness to a 6F predicate device.

Here's a breakdown of the acceptance criteria and the study information based on the provided text, structured according to your request:

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

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

The provided text does not specify the sample size used for the test set or the data provenance. The document indicates that tests were performed ("Test results verified"), but there are no details on the number of catheters or samples tested, nor where the testing was conducted or if it was retrospective or prospective.

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 information is not provided in the document. The document refers generally to "Test results" and "specifications" for a medical device (guiding catheter), which typically involve engineering and material science testing, rather than human expert interpretation of data like images. Therefore, the concept of "experts" establishing ground truth in this context (for mechanical and material properties) is not directly applicable in the same way it would be for AI-powered diagnostic devices.

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

This information is not provided and is not typically relevant for the type of device (guiding catheter) or the nature of the testing described (biocompatibility, performance specifications of physical attributes). Adjudication methods are more commonly associated with human interpretation tasks or clinical endpoints requiring consensus.

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

There is no indication of an MRMC comparative effectiveness study being conducted. This device is a guiding catheter, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, the concept of "human readers improve with AI" is not applicable here.

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

This question is not applicable as the device is a physical guiding catheter, not an algorithm or AI system.

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

For the performance criteria mentioned (biocompatibility, inner lumen diameter, stiffness), the "ground truth" would be established by standardized laboratory testing procedures, physical measurements, and adherence to predefined material science and engineering specifications. For example, biocompatibility testing would follow ISO standards, diameter measurements would use precision instruments, and stiffness testing would involve specific mechanical test setups.

8. The sample size for the training set

This information is not applicable. This document describes the 510(k) submission for a physical medical device (guiding catheter), not a machine learning model. There is no concept of a "training set" in this context.

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

This question is not applicable for the same reason as point 8.

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