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The TracStar Large Distal Platform is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The ZOOM 88 and ZOOM 88-T Large Distal Platform are indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Imperative Care Large Distal Platform (LDP) Catheters include the TracStar™ LDP, Zoom™ 88 LDP and Zoom™ 88-T LDP. The LDP Catheters are 0.038" or smaller guidewire compatible single lumen guide catheters that provide access to peripheral, coronary and neuro vasculature. The catheters are comprised of a hollow cylindrical tube bonded at the proximal end to a standard luer fitting. The wall of the tube is constructed using a combination of metal coils/braids and medical grade polymers. The distal section of each catheter has a hydrophilic coating to enhance tracking through tortuous vasculature. An angled distal soft tip facilitates smooth tracking past vessel branches. A radiopaque marker provides visual confirmation of the distal tip location under fluoroscopy. LDP Catheters have an inner diameter of 0.088" (6F compatible), and a maximum outer diameter of 0.110". The LDP guide catheters are packaged with a rotating hemostasis valve (RHV) that is attached to the proximal luer to help maintain hemostasis.

This document is a 510(k) Summary for a medical device (TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform). It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study with human readers or AI algorithms for diagnostic purposes. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and performance specifications for the physical catheter device, not a diagnostic algorithm's performance on medical images.

Therefore, many of the requested items related to AI/MRMC studies, ground truth establishment, expert adjudication, and training/test set sample sizes are not applicable here.

However, I can extract information related to the device's physical performance testing.

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

The document provides a table of "Test Attributes" (which serve as acceptance criteria) and the "Results". All tests passed their respective specifications.

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

The document describes "Bench and Laboratory (in-vitro) testing" and "simulated neurological model". This indicates the testing was conducted in a lab environment using physical devices. There is no information provided about the specific number of devices tested for each attribute (sample size for the test set) or the country of origin of this test data. The testing would be prospective in nature as it's active testing performed to gather data for regulatory submission.

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

Not applicable. This is a physical device performance test, not a diagnostic imaging study requiring expert interpretation or ground truth establishment in the healthcare sense.

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

Not applicable. This is a physical device performance test.

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 a physical device, not an AI diagnostic tool.

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

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

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

The "ground truth" here is determined by engineering specifications and objective measurements against those specifications in a laboratory setting. For example, for "Freedom from Leakage", the ground truth is simply "no liquid leakage" or "no air leakage" under specified conditions. For "Kink Resistance", the ground truth is "no permanent deformation".

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model that undergoes a training phase.

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

Not applicable. As above, this is a physical medical device, not a machine learning model.

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