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

The provided text is a 510(k) summary for the AngioJet Solent Proxi Thrombectomy Set. It describes the device, its intended use, and lists various performance tests conducted. However, it does not provide specific quantitative acceptance criteria or detailed results to demonstrate that the device meets those criteria. It also doesn't describe the studies in the way requested in the prompt, focusing instead on the types of tests performed rather than the methodology and specific outcomes against acceptance thresholds.

Given the information available in the document, I can only address the questions to the extent possible. Much of the information requested (such as sample sizes for test sets, ground truth establishment for training and test sets, number/qualifications of experts, adjudication methods, and MRMC studies) is not present in this regulatory submission for a medical device that acts mechanically rather than using AI/machine learning.

Here's an attempt to answer the questions based only on the provided text, with explicit notes where information is not available:

1. Table of acceptance criteria and the reported device performance

   The document lists the types of performance tests conducted but does not specify quantitative acceptance criteria or the reported performance values against those criteria. It only states that "Results from the testing provide assurance that the proposed device conforms to the requirements for its intended use."

   Acceptance Criterion (Not specified in document)	Reported Device Performance (No specific data reported)
   e.g., Biocompatibility: No cytotoxicity	"Biocompatibility" testing was performed.
   e.g., Leak testing: No leaks observed	"Leak testing" was performed.
   e.g., Clot removal: X% efficacy	"Clot removal" testing was performed.
   e.g., Hemolysis: Y% reduction	"Hemolysis" testing was performed.

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

   • Sample Size: Not specified in the document for any of the performance tests.
   • Data Provenance: The studies were internal "Bench and laboratory testing" conducted by MEDRAD Interventional / Possis. No information is given regarding country of origin or whether the data was retrospective or prospective, though for bench testing, these terms are less relevant than for clinical studies.

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 medical device, not an AI/ML diagnostic tool requiring expert ground truth for image or data interpretation. The "ground truth" for mechanical performance tests would be based on validated measurement techniques and specifications.

4. Adjudication method for the test set

   Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on medical images or diagnoses, which is not relevant for the type of device and testing 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

   No. This device is an AngioJet Solent Proxi Thrombectomy Set, a mechanical thrombectomy device, and is not an AI/ML-based diagnostic or assistive software. Therefore, an MRMC study related to human readers improving with AI assistance is not applicable.

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

   No. This device is a physical medical device (thrombectomy set) that requires human operation, not a standalone algorithm.

7. The type of ground truth used

   For the performance data listed (biocompatibility, leak testing, clot removal, hemolysis, etc.), the "ground truth" would be established by:

   • Standardized Test Methods: Using recognized international (e.g., ISO, ASTM) and internal test protocols with predefined acceptance criteria.
   • Physical Measurements: Quantifiable measurements from bench and laboratory tests (e.g., tensile strength, temperature, fluid dynamics).
   • Analytical Chemistry/Biology: Results from biocompatibility assays (e.g., cytotoxicity, sensitization, hemocompatibility assays).

8. The sample size for the training set

   Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

   Not applicable. No training set is involved for this type of device.

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