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The Excelsior XT-27 Microcatheter and Excelsior XT-27 Flex Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The Excelsior XT-27 Pre-Shaped Microcatheter and Excelsior XT-27 Flex Pre-Shaped Microcatheter are intended to assist in the delivery of embolization particles, diagnostic agents (such as contrast media), and interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The subject devices hereafter referred to as Excelsior® XT-27® Microcatheters are sterile, single lumen, 0.027 inch inner diameter (ID) microcatheters with one tip marker designed to aid the physician in accessing distal neurovasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization® XT-27® Microcatheters are coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.

The Excelsior® XT-27® Microcatheters are available in effective lengths of both 135 cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and pre-shaped versions are available.

The provided text is a 510(k) summary for a medical device (Excelsior XT-27 Microcatheters) and details its acceptance criteria and the study performed to demonstrate substantial equivalence, but it does not describe an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample sizes for test and training sets, number of experts for ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and data provenance) are not applicable to this document.

However, I can provide the acceptance criteria and study information that is available for this mechanical microcatheter from the document.

1. 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):

• Sample Size for Test Set: The document does not specify the exact number of samples (e.g., number of microcatheters tested) used for each bench test. It mentions testing with "ancillary devices that represent worst-case sizes" for the Guide Catheter Compatibility test and "worst-case sized ancillary devices and interventional devices" for the Tensile Strength test.
• Data Provenance: The study is described as "Bench testing," indicating it was conducted in a laboratory setting. There is no information regarding country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies involving human or animal subjects.

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 as this is a mechanical device performance study, not an AI/ML diagnostic or prognostic study requiring expert opinion for ground truth. The "ground truth" here is the physical performance of the device against engineering specifications.

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

• Not applicable for the same reason as point 3. Bench testing results are typically adjudicated by meeting predefined engineering specifications and criteria, not by expert consensus in the same way as diagnostic reads.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for AI-assisted diagnostic devices, which is not what this device is.

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

• Not applicable. This is a physical medical device (microcatheter), not an algorithm.

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

• The "ground truth" in this context is based on engineering specifications and performance criteria for the physical device. For example, for tensile strength, the ground truth would be a defined minimum force the joints and marker band must withstand without failure. For compatibility, it would be the ability to successfully deliver and retrieve the microcatheter within the specified guide catheter with acceptable force.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable for the same reason as point 8.

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The Excelsior XT-27 Microcatheter is intended to assist in the delivery of diagnostic agents (such as contrast media), therapeutic agents, and non- liquid interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

The Excelsior® XT-27™ Microcatheter is a sterile, single lumen 0.027 in ID device with one tip marker designed to aid the physician in accessing distal vasculature when used with a guide catheter and steerable guidewire. Graded shaft stiffness ranging from a highly flexible tip to a semi-rigid proximal section aids the physician in tracking over selectively placed guidewires. A luer fitting located on the microcatheter hub is used for the attachment of accessories. One radiopaque tip marker is positioned at the distal tip of the device to facilitate fluoroscopic visualization. The Excelsior XT-27 Microcatheter is coated on the outer surface with Hydrolene™ coating which reduces friction during manipulation in the vessel.

The Excelsior XT-27 Microcatheters are available in effective lengths of both 135cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft configurations achieved through distal shaft lengths of 6 cm (XT-27 model) and 18 cm (XT-27 Flex model). Both straight tip and Pre-Shaped versions are available.

This document describes the Stryker Neurovascular Excelsior® XT-27™ Microcatheter and its 510(k) submission for market clearance. The submission relies on demonstrating substantial equivalence to predicate devices through a series of bench tests.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Excelsior XT-27 Microcatheter are largely based on demonstrating equivalence to the predicate devices (K000177, Renegade™ Hi-Flo™ Microcatheter and K042568, Excelsior® SL-10 Pre-Shaped Microcatheter). The "Result" column explicitly states "Met same criteria as predicate," indicating that the performance of the Excelsior XT-27 Microcatheter was found to be comparable to or better than the predicate devices for these specific tests.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each of the bench tests. It also does not provide information about data provenance in terms of country of origin or whether the tests were retrospective or prospective. Given the nature of bench testing for a medical device, it is typically prospective, with samples of the device being manufactured and then tested in controlled laboratory environments.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the document. For bench testing, "ground truth" is typically established through adherence to test methodologies and specifications, often informed by engineering standards and regulatory guidance, rather than expert consensus on individual cases.

4. Adjudication Method for the Test Set

This information is not provided. As mentioned above, bench testing relies on objective measurements and predefined acceptance criteria rather than expert adjudication in the way clinical studies might.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable and not provided. The Excelsior XT-27 Microcatheter is a physical medical device (microcatheter), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance would not be relevant to its evaluation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable and not provided. As it is a physical medical device, there is no "algorithm only" performance to be evaluated in a standalone manner.

7. The Type of Ground Truth Used

The ground truth for most of these tests is established by:

• Engineering Specifications and Design Requirements: For dimensional measurements, kink radius, advancement/retraction force.
• Established Biomedical Test Standards: For biocompatibility tests (cytotoxicity, irritation, systemic toxicity, sensitization, hemocompatibility, pyrogenicity, USP impurities, latex). These standards define the methods and acceptance criteria for classifying a material as non-toxic, non-irritating, etc.
• Comparison to Predicate Device Performance: For many performance characteristics (e.g., visual inspection, simulated use), the "ground truth" for the new device is that its performance must be equivalent or superior to the already legally marketed predicate devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering iterations, but this is distinct from an algorithmic training process.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and not provided for the same reasons as point 8.

In Summary:

The document focuses on demonstrating substantial equivalence of the Excelsior® XT-27™ Microcatheter to its predicate devices through comprehensive bench testing. The acceptance criteria for most tests are implicitly or explicitly that the new device must perform comparably to (or better than) the predicate devices, or meet established safety and performance standards (especially for biocompatibility). The study design is largely a series of controlled laboratory tests performed on samples of the device. Aspects related to AI, human readers, or large-scale data training sets are not relevant to this type of device submission and therefore not included.

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