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The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are designed for the introduction of interventional devices into the peripheral and neurovasculature. The Arc™ Mini are a single lumen, flexible, variable stiffness composite catheters with a Nitinol structure. A radiopaque marker band on the distal tip of the devices is used for visualization under fluoroscopy. The distal sections of both catheters are coated with a hydrophilic coating, which is used to reduce the overall frictional force during intravascular use. The Arc™ and Arc™ Mini dimensions are included in the individual device label. The devices are supplied sterile and are intended for single-use only.

This document is a 510(k) Pre-Market Notification for the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter. It focuses on establishing substantial equivalence to a predicate device (ReFlex™ Guide Catheter) through non-clinical testing. Therefore, it does not involve AI/ML performance criteria, human reader studies, or training/test sets as commonly understood in AI device submissions.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Biocompatibility Testing:

Regarding AI/ML-specific questions (2-9):

This document describes a traditional medical device submission (catheter) focused on demonstrating substantial equivalence through bench testing, design validation, and biocompatibility testing. It does not involve software with AI/ML components for which these specific questions would be relevant. Therefore, most of these questions are not applicable.

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. This is a hardware device submission. Bench testing involved samples of the catheters, but not in the context of "test sets" for AI/ML validation. The document does not specify exact sample sizes for each bench test, but implies sufficient samples were used to meet statistical validity for the stated conclusions.

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 needed for AI/ML performance. Physician Usability Testing involved users, implied to be qualified, but not "experts establishing ground truth" as defined for AI/ML.

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

• Not Applicable. No adjudication for AI/ML performance.

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. No AI/ML component; therefore, no MRMC study.

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

• Not Applicable. No AI/ML algorithm.

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

• Not Applicable. Ground truth, in the context of an AI/ML device, does not apply here. The "ground truth" for this device's performance are the established standards and specifications for mechanical performance, material properties, and biocompatibility, against which the device was tested.

8. The sample size for the training set

• Not Applicable. No AI/ML training set.

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

• Not Applicable. No AI/ML training set or ground truth establishment.

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