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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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