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The ZelanteDVT™ Thrombectomy Set is intended for the removal of thrombus from and infusion of fluids into the peripheral vasculature.

The ZelanteDVT™ Thrombectomy Set is intended for use with the AngioJet® Ultra Console to break apart and remove thrombus, including deep vein thrombus (DVT), from:

· Iliofemoral and lower extremity veins ≥ 6.0 mm in diameter and

· Upper extremity peripheral veins ≥ 6.0 mm in diameter.

The ZelanteDVT Thrombectomy Set is also intended for use with the AngioJet Ultra Power Pulse® technique for the controlled and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

The ZelanteDVTT™ Thrombectomy Set is one component of the AngioJet® Ultra Thrombectomy System (AngioJet Ultra System). The other component, packaged and sold separately, is the multiple-use AngioJet® Ultra Console. The ZelanteDVT Thrombectomy Set can only be used in conjunction with the AngioJet Ultra Console.

The ZelanteDVT Thrombectomy Set uses high-velocity saline to create a low pressure zone at the catheter tip. Thrombus is drawn into the catheter where it is fragmented by the jets and evacuated from the body. The waste tubing transports the thrombus debris from the catheter to the waste collection bag for ultimate disposal.

The 105 cm ZelanteDVT Thrombectomy Catheter is introduced through an 8F introducer sheath and tracks and operates over a 0.035" (0.89 mm) guidewire. The manifold is equipped with a port with an attached stopcock. This port can be used to inject contrast media and other fluids into the bloodstream.

This document is a 510(k) premarket notification for the ZelanteDVT™ Thrombectomy Set. It describes the device, its intended use, and indicates its substantial equivalence to a predicate device. However, this document does not contain the detailed acceptance criteria or the specific study that proves the device meets those criteria in the format requested.

Here's an analysis of what is available and what is missing based on your request:

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

• Missing. The document lists various nonclinical tests performed (biocompatibility and in vitro performance tests) such as "Hemolysis Ratio", "Clot Removal", "Net Evacuation", etc., but it does not provide specific quantitative acceptance criteria (e.g., "Hemolysis Ratio < X%") or the numerical results achieved by the device for these tests. It only states that the tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised."

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

• Partially available/Missing. The document mentions "Acute and Chronic GLP studies were performed to evaluate the safety and performance of the ZelanteDVT Thrombectomy Set in peripheral veins." "GLP studies" implies prospective animal (in vivo) studies conducted under Good Laboratory Practice regulations, which would include a test set. However, the specific sample size for these studies is not provided. The provenance would be animal studies, but no country of origin is specified.
• For the in vitro performance tests, the "test set" would typically refer to the number of devices or test articles subjected to each test. This is not specified.

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 / Missing. This question is typically relevant for studies involving human interpretation of medical images or clinical outcomes. The studies mentioned are nonclinical (biocompatibility, in vitro performance, animal GLP studies). Therefore, there would not be "experts" in the sense of radiologists establishing ground truth from images. The "ground truth" for these types of studies would be objective measurements or observations during the lab or animal testing.

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

• Not applicable / Missing. Similar to point 3, adjudication methods are typically used in clinical trials or studies where human interpretation or subjective assessment is involved, often to resolve discrepancies between readers. This is not mentioned or relevant for the nonclinical tests described.

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 / Missing. The device is a thrombectomy set (a physical medical device), not an AI algorithm or an imaging device requiring human interpretation for diagnosis. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.

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

• Not applicable / Missing. This question pertains to the performance of an AI algorithm on its own. The ZelanteDVT Thrombectomy Set is a physical medical device, not an AI algorithm.

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

• Partially available. For the nonclinical in vitro tests, the ground truth would be objective measurements obtained through standardized laboratory procedures (e.g., measuring clot removal percentage, fluid flow rates, tensile strength, hemolysis ratio).
• For the Acute and Chronic GLP animal studies, the ground truth would be direct observation of physiological effects, pathological examination of tissues, or other objective measures of safety and performance (e.g., absence of signs of thrombus, vessel integrity). The document does not go into detail on the specific endpoints used for "safety and performance" in these animal studies.

8. The sample size for the training set

• Not applicable / Missing. This question is relevant for machine learning or AI models, which require a "training set." This document describes a traditional medical device, not an AI product.

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

• Not applicable / Missing. As above, this pertains to AI models.

In summary, the provided document is a regulatory submission for a physical medical device, and as such, it focuses on demonstrating substantial equivalence through nonclinical testing (biocompatibility, in vitro performance, and animal studies). It does not provide the kind of detailed clinical study results, particularly those related to human reader performance or AI, that your questions anticipate. For a comprehensive answer matching your request, you would typically need a clinical trial report or a more detailed technical report which would accompany such a 510(k) submission, but is not included in this FDA letter and summary.

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