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The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from :

• upper and lower extremity peripheral arteries ≥ 3.0mm in diameter, .
• . upper extremity peripheral veins ≥ 3.0mm in diameter,
• ileofemoral and lower extremity veins ≥ 3.0mm in diameter, .
• A-V access conduits > 3.0mm in diameter and o
• for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of e physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes a Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.

This document (K113428) is a 510(k) premarket notification for a medical device called the AngioJet Ultra DVX Thrombectomy Set. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and proving performance through extensive clinical studies like those for novel AI/ML devices or entirely new technologies.

Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable or not provided in this type of regulatory submission as it relates to a device with limited design changes from its predicate.

Here's an analysis based on the provided document, addressing what is present and noting what is absent:

Acceptance Criteria and Study for AngioJet Ultra DVX Thrombectomy Set (K113428)

The device is a PIVOTAL device in so much that it is a modified version of an existing device. The acceptance is based on equivalency to a device that has already established safety and efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are not framed as specific performance metrics against an outcome (e.g., disease detection accuracy), but rather as a demonstration of equivalent performance and safety compared to its predicate devices despite a minor design change. The design change involved making the distal section more robust for guide wire use.

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

• Sample Size: Not explicitly stated in this 510(k) summary. The testing refers to "bench testing" which typically involves a set number of units or iterations of the device in a laboratory setting. This is not a clinical study involving patient data.
• Data Provenance: N/A. The data comes from internal bench testing (laboratory experiments) conducted by the manufacturer, MEDRAD, Inc. It is not patient data from a specific country, nor is it retrospective or prospective clinical data.

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

• N/A. Since this involves bench testing of a device rather than interpretation of medical images or patient outcomes, there are no "experts" establishing a "ground truth" in the clinical sense. The ground truth for bench tests is typically established by engineering specifications, validated test methods, and measurement against known standards.

4. Adjudication Method for the Test Set

• N/A. No adjudication method is applicable as this is bench testing, not an assessment requiring consensus among human interpreters.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• No. An MRMC study was not done. This type of study is relevant for diagnostic imaging AI devices where human performance with and without AI assistance is compared. This device is a mechanical thrombectomy device, and its performance is evaluated through engineering bench tests, not comparative reading studies.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

• N/A. This device is a physical medical device (catheter and pump set), not an AI algorithm. Therefore, "standalone performance" in the context of an algorithm is not applicable. Its performance is inherent to its mechanical and hydraulic functions.

7. The Type of Ground Truth Used

• For this device, the "ground truth" for the bench testing is defined by engineering specifications, physical measurements, and compliance with industry standards relevant to catheter performance, mechanical integrity, and biological interactions (e.g., hemolysis). It is not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• N/A. There is no "training set" as this is not an AI/ML algorithm that learns from data.

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

• N/A. Not applicable, as there is no training set for this type of device.

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The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from

• . Upper and Lower extremity peripheral arteries > 3 mm in diameter
• . Upper extremity peripheral veins > 3 mm in diameter
• Ileofemoral and lower extremity veins ≥ 3 mm in diameter .
• . AV access conduits > 3 mm in diameter and
• . For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

The AngioJet Ultra Xpeedior Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from

• Upper and Lower extremity peripheral arteries ≥ 3 mm in diameter .
• Upper extremity peripheral veins > 3 mm in diameter .
• lleofemoral and lower extremity veins > 3 mm in diameter .
• . A V access conduits > 3 mm in diameter and
• For use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of ● physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are sterile, single use, disposable sets that include the AngioJet DVX and Xpeedior Thrombectomy catheters and a pump in one combined unit. The AngioJet Ultra DVX and Xpeedior Thrombectomy Sets are used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the bloodstream where the catheter is positioned.

The provided text is a 510(k) summary for the AngioJet Ultra DVX and Xpeedior Thrombectomy Sets. This document outlines the device's intended use and demonstrates its substantial equivalence to previously cleared predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria as typically found in clinical trials for new medical device approvals or AI/CAD performance assessment.

Instead, the provided text describes an administrative change to a previous 510(k) clearance and the original 510(k) submission which focuses on demonstrating substantial equivalence to predicate devices based on similarities in functional design, materials, indications for use, and principles of operation, supported by bench and biocompatibility testing.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving the device meets those criteria from the provided text. The document focuses on regulatory clearance through substantial equivalence, not on novel performance evaluation against specific metrics like sensitivity, specificity, etc., usually associated with acceptance criteria for new or AI-powered devices.

Here's a breakdown of what can be extracted or inferred, and what cannot:

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

• Cannot be provided: The document does not define specific acceptance criteria (e.g., minimum sensitivity, specificity, accuracy, or similar quantitative metrics) for the device's performance in breaking apart and removing thrombus. It also does not report specific device performance statistics against such criteria. The "Supporting Information" section mentions "Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions," but it doesn't detail performance metrics or acceptance criteria for these tests.

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

• Cannot be provided: The document does not describe a clinical "test set" in the context of diagnostic or AI performance evaluation. The testing mentioned is "Bench and biocompatibility testing," which are typically laboratory-based and do not involve patient data in the same way as a clinical test set for AI/CAD. Therefore, data provenance (country, retrospective/prospective) for such a test set is not applicable or provided.

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

• Cannot be provided: No "ground truth" establishment by experts for a clinical test set is mentioned. This is a 510(k) submission focusing on substantial equivalence, not a clinical trial evaluating diagnostic accuracy against a gold standard.

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

• Cannot be provided: No clinical test set or adjudication process is 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:

• Cannot be provided: This device is a mechanical thrombectomy set, not an AI or imaging diagnostic aid for which an MRMC study comparing human readers with and without AI assistance would be relevant. The document does not mention any AI component.

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

• Cannot be provided: This device is a physical medical device (catheter) used by a medical professional. It is not an algorithm, so the concept of "standalone performance" for an algorithm is not applicable.

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

• Cannot be provided: As no clinical test set for diagnostic accuracy is described, no ground truth type is specified. The assessment here is about the device's physical properties and intended function (breaking apart and removing thrombus), likely evaluated through engineered performance tests and simulations, rather than diagnostic "ground truth."

8. The sample size for the training set:

• Cannot be provided: This device is not an AI algorithm, so there is no "training set."

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

• Cannot be provided: Not applicable as there is no AI algorithm or training set discussed.

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The AngioJet Ultra DVX Thrombectomy Set is intended for use with the AngioJet Ultra Console to break apart and remove thrombus from upper and lower extremity peripheral arteries ≥3 mm in diameter; break apart and remove thrombus from upper extremity and infra-inguinal lower extremity peripheral veins ≥3 mm in diameter; and for use with the AngioJet Ultra Power Pulse Kit for the control and selective infusion of physician specified fluids, including thrombolytic agents, into the peripheral vascular system.

Each AngioJet Ultra DVX Thrombectomy Set is a sterile, single use, disposable set that includes the Thrombectomy Catheter and Pump in one combined unit. The AngioJet Ultra DVX Thrombectomy Set is used with the AngioJet Ultra Console.

This document is a 510(k) summary for the AngioJet Ultra DVX Thrombectomy Set, which is a medical device intended to remove thrombus from peripheral arteries and veins. However, it does not contain the specific information required to complete the table and answer all questions related to acceptance criteria and study details.

Here's a breakdown of what can and cannot be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size: Not specified. The document mentions "representative samples" for bench testing.
• Data provenance: Not specified. These are likely internal lab tests (bench testing) and not human clinical data.

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

• Not applicable. The document describes bench testing, not a study involving ground truth established by experts.

4. Adjudication method for the test set:

• Not applicable. As above, this was bench testing, not a study requiring adjudication.

5. Multi-reader multi-case (MRMC) comparative effectiveness study:

• No. The document does not mention an MRMC comparative effectiveness study. It states "comparative testing to demonstrate appropriate functional and performance characteristics" but this refers to comparison with predicate devices, not human readers with and without AI assistance.
• Effect size: Not applicable, as no such study was performed.

6. Standalone (algorithm only without human-in-the-loop performance) study:

• The device is a physical thrombectomy set used in a medical procedure, not an AI algorithm. Therefore, a standalone (algorithm only) study is not applicable. The bench testing performed could be considered a form of standalone performance evaluation for the physical device.

7. Type of ground truth used:

• For the described bench testing, the "ground truth" would be established by the physical and chemical properties measured during mechanical, biocompatibility, and sterility tests. This is not "expert consensus, pathology, or outcomes data" in the typical sense for a diagnostic device.

8. Sample size for the training set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical medical device, not an AI model.

In summary:

This 510(k) notification focuses on demonstrating substantial equivalence of the AngioJet Ultra DVX Thrombectomy Set to predicate devices based on functional design, materials, indications for use, and principles of operation, supported by bench testing. It does not provide the detailed information about acceptance criteria or a study with expert-adjudicated ground truth and clinical performance metrics that would be typically found for diagnostic AI devices.

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