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The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support, and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.

The Cordis Neurovascular, Inc. HYPERTRANSIT™ Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips.

The information provided describes the HYPERTRANSIT™ Infusion Catheter and its testing for substantial equivalence to a predicate device. This submission focuses on in-vitro testing to address design changes for improved kink resistance. It does not describe a study involving human readers, AI, or expert ground truth in the way a diagnostic AI device would.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) are not applicable to the provided document, as it pertains to a physical medical device and its mechanical performance testing.

Here's the breakdown of the available information:

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

The document lists the types of in-vitro tests conducted but does not provide specific acceptance criteria or quantitative performance results for each test. Instead, it states that these tests were conducted "to support substantial equivalence to the predicate device, addressing the design changes made to improve kink resistance at the distal end of the strain relief." The conclusion is that the proposed device is "similar in its basic design, construction, indication for use, and performance characteristics to the predicate HYPERTRANSIT™ Infusion Catheter."

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

Not applicable. The study involved in-vitro testing of a physical medical device, not a diagnostic algorithm with a test set of data.

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. Ground truth as typically understood for diagnostic AI devices (e.g., expert consensus on medical images) is not relevant to this in-vitro mechanical device testing.

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

Not applicable. No expert adjudication process is described for this in-vitro mechanical device testing.

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 is not a study involving human readers or AI assistance.

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

Not applicable. This is not an algorithm, but a physical medical device.

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

For the in-vitro tests, the "ground truth" would be established by objective physical measurements and adherence to engineering specifications and performance characteristics demonstrating equivalency to the predicate device. The document implies compliance with these standards through the conducted tests.

8. The sample size for the training set

Not applicable. This is not a machine learning model; therefore, there is no training set.

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

Not applicable. There is no training set mentioned.

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The HYPERTRANSIT™ Infusion Catheter is intended to be used as a mechanism for the infusion of various diagnostic and embolic agents in the coronary, neuro and peripheral vasculatures, for guidewire exchange/support and for superselective angiography of the peripheral and coronary vessels. The device is also intended to be used for infusion of therapeutic agents in the coronary and peripheral vasculature. All agents must be used in accordance with manufacturer's instructions for use.

The Cordis Neurovascular, Inc. HYPERTRANSIT Infusion Catheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. Each configuration has a hydrophilic coating to provide lubricity for navigation of vessels. The inner lumen is lined with PTFE to facilitate movement of guidewires and other devices. The catheter body is radiopaque to aid visualization under fluoroscopy, and the distal tip is distinguished by a radiopaque marker. Select configurations are available with pre-shaped tips.

The provided 510(k) summary describes a medical device, the HYPERTRANSIT™ Infusion Catheter, and its substantial equivalence to predicate devices, rather than establishing acceptance criteria and proving the device meets those criteria through a standalone study with specific performance metrics.

Instead, the document details comparative and performance testing to demonstrate safety and effectiveness and substantial equivalence to existing devices already on the market. It does not present acceptance criteria with target performance metrics like sensitivity, specificity, or accuracy that would be typical for an AI/ML medical device.

Therefore, many of the requested elements for an AI/ML device study, such as sample sizes for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable or available in this document.

However, I can extract information related to the types of testing conducted and the basis for substantial equivalence.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This section is adapted as the document focuses on equivalence and performance testing rather than acceptance criteria for an AI/driven device's diagnostic performance. The "Acceptance Criteria" here are implicitly meeting performance benchmarks comparable to predicate devices and acceptable safety profiles. "Reported Device Performance" refers to the successful completion of these tests as implied by the FDA's clearance.

Not Applicable / Not Provided Information for AI/ML Device Study:

The following information is not present in the given document because the device (HYPERTRANSIT™ Infusion Catheter) is a physical medical device, not an AI/ML software or algorithm requiring diagnostic performance metrics.

2. Sample size used for the test set and the data provenance

• Not Applicable. This document describes testing for a physical catheter, not an AI/ML algorithm that uses a test set of data. The "test set" would refer to the catheters themselves undergoing various physical and functional tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. Ground truth, in the context of AI/ML, refers to a label or diagnosis established by experts for a dataset. For a physical device, testing involves measuring physical properties or observing performance in simulated/animal environments, not expert labeling of data.

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

• Not Applicable. Adjudication methods are used to resolve discrepancies in expert labeling for AI/ML ground truth. This is not relevant for testing a physical instrument.

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. MRMC studies are specific to AI/ML devices that aim to assist human readers in tasks like image interpretation. This device is a catheter.

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

• Not Applicable. This refers to the performance of an AI algorithm in isolation. The HYPERTRANSIT™ Infusion Catheter is a physical device used by clinicians.

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

• Not Applicable. For the physical device, "ground truth" is established by engineering specifications, validated test methods (e.g., for flow rate, burst pressure), and clinical/biological observations in animal studies.

8. The sample size for the training set

• Not Applicable. Training sets are used for machine learning. This document describes the development and testing of a physical medical device.

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

• Not Applicable. As there is no AI/ML training set, the concept of establishing ground truth for it is irrelevant in this context.

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