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The guiding catheter is designed to provide a pathway through which therapeutic and diagnostic devices are introduced.

The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has a standard working length of 100 cm and a standard overall length of 107 cm, but can be produced in lengths from 40 to 160 cm depending upon physician preference and patient size.

The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has a radiopaque shaft, which varies in stiffness at the distal end to accommodate customer preference and give optimal support in each tip shape. The stiffness of the shaft is determined by the durometer of the segment of polymer along the axial length. The lower the durometer of polymer (or polymer blend of Nylon 12 and/or Pebax), the more flexible the guiding catheter. The Pebax raw material durometers vary from 25D to 72D. The guiding catheter also has a radiopaque soft tip at the most distal section.

The proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter is manufactured in varying tip shapes. Each shape is specific for patient anatomy and physician preference, and therefore a wide range of shapes is available with and without sideholes.

The document provided is a 510(k) premarket notification for a medical device, the VIKING OPTIMA™ Guiding Catheter. It describes the device, its intended use, and states that substantial equivalence has been demonstrated through non-clinical bench tests and analyses. However, it does not contain specific acceptance criteria, reported device performance metrics, or details of a study that proves the device meets specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and study information. The provided text is primarily a regulatory submission for substantial equivalence based on bench testing, and not a detailed performance study with quantifiable acceptance criteria for a new AI/software-based device.

Here's how I can address your request based on the information provided:

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

• Not applicable / Information not provided. The document states that "The substantial equivalence of the proposed (7F, 8F) VIKING OPTIMATM Guiding Catheter has been demonstrated through data collected from non-clinical bench tests and analyses." However, it does not specify the exact acceptance criteria for these bench tests nor the quantitative results of those tests. The submission focuses on showing similarity to a predicate device (K001435) rather than meeting predefined performance metrics.

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 / Information not provided. The study referenced is "non-clinical bench tests and analyses." There is no mention of a "test set" in the context of patient data or clinical imaging.

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 / Information not provided. As this was a non-clinical bench test, there was no ground truth requiring expert consensus in the clinical sense.

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

• Not applicable / Information not provided. This refers to clinical data review, which was not part of the described evaluation.

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 document describes a physical medical device (guiding catheter), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

• Not applicable. This document describes a physical medical device, not an algorithm.

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

• Not applicable / Information not provided. The "performance data" mentioned refers to non-clinical bench tests, likely measuring physical attributes of the catheter against engineering specifications or predicate device characteristics, rather than clinical ground truth like pathology or outcomes.

8. The sample size for the training set

• Not applicable / Information not provided. There is no mention of a "training set" as this is not a machine learning or AI device.

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

• Not applicable / Information not provided. Not applicable to this type of device and study.

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