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The Cannula is indicated for
· the non-surgical removal of thrombi or emboli from vasculature.
· aspiration of contrast media and other fluids from vasculature.
The Cannula is intended for use in the venous system.
The Handle is indicated as a vacuum source for the AlphaVac MMA System.

The AlphaVac Multipurpose Mechanical Aspiration (MMA) System is a single use-over-wire catheter- based system that facilitates the removal of thrombus, or clot during minimally invasive percutaneous procedures. The AlphaVac MMA System is comprised of six main components packaged together:

• a flexible AlphaVac Cannula with self-expandable, nitinol reinforced, angled funnel shaped distal tip
• . AlphaVac Sheath
• . AlphaVac Obturator
• AlphaVac Handle
• Waste Bag and Tubing
  The AlphaVac Cannula is placed within target vasculature using standard percutaneous vascular access techniques (i.e. Seldinger) and commonly available vascular access tools (e.g., guidewire, vascular introducers, etc.). Once the cannula is in place, the AlphaVac Handle and waste bag is connected and primed. The AlphaVac Cannula is advanced out of the sheath and the nitinol basket automatically expands into a funnel, aiding in the removal of thrombus, emboli, and clot. The aspiration handle is pulled back creating suction and pulling the material into the catheter, removing it from the vasculature. The aspirated material is captured within the waste bag for disposal. Target vessels for include, but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC), and Right Heart (Atrium (RA)). The device is provided in ~20° (AlphaVac 25F/C20) and ~180° (AlphaVac 25F/C180) angled configurations.

The provided text is a 510(k) summary for the AlphaVac Multipurpose Mechanical Aspiration (MMA) System. It details information typically included in a regulatory submission for medical devices to prove substantial equivalence to a predicate device. However, it does not include specific information regarding acceptance criteria for device performance studies, nor does it describe a study that explicitly demonstrates the device "meets" those acceptance criteria in the way a clinical trial or a performance study with defined endpoints would.

Instead, the document focuses on demonstrating substantial equivalence through bench testing, biocompatibility, sterilization, and a comparison of technological characteristics with a predicate device. It briefly mentions "Previous animal studies also contributed to demonstrating substantial equivalence," but no details on the study design, acceptance criteria, or results are provided.

Therefore, many of the requested pieces of information cannot be extracted from the provided text. I will address the points that can be inferred or explicitly stated.

Acceptance Criteria and Device Performance for AlphaVac Multipurpose Mechanical Aspiration (MMA) System

The provided 510(k) summary does not explicitly list acceptance criteria in terms of specific performance thresholds for a study designed to prove the device meets those criteria. Instead, it outlines a series of tests performed to support substantial equivalence to a predicate device (FlowTriever Retrieval/Aspiration System). The "reported device performance" is described as successfully meeting "all specified design and performance requirements" for these non-clinical tests.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria are not provided, this table will summarize the types of tests performed and the general outcome as stated in the document.

2. Sample size used for the test set and the data provenance:
The document refers to "comprehensive bench testing" and "previous animal studies." However, no specific sample sizes for these tests are provided. Data provenance is not explicitly stated beyond "performed by AngioDynamics and independent test houses" for sterilization/shelf life and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The document describes non-clinical engineering and biological tests, not a clinical study with expert-established ground truth. Human Factors/Usability Evaluation was performed, which would typically involve users, but the details are not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a diagnostic device requiring adjudication of interpretations.

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 an AI-assisted diagnostic imaging device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a mechanical aspiration device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the bench tests, the "ground truth" would be established engineering specifications, material standards, and regulatory requirements (e.g., ISO, FDA guidance). For biocompatibility, it's ISO 10993 standards. For animal studies, the ground truth would be based on physiological observations and post-mortem analysis.

8. The sample size for the training set:
Not applicable. This refers to a medical device's non-clinical performance and substantial equivalence, not a machine learning model.

9. How the ground truth for the training set was established:
Not applicable.

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Triever Catheters are indicated for:

· The non-surgical removal of emboli and thrombi from blood vessels.

• · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
  Triever Catheters are intended for use in the peripheral vasculature and for the treatment of pulmonary embolism. Triever Catheters are also intended for use in transit in the right atrium, but not in conjunction with FlowTriever Catheters.

The FlowTriever Retrieval/Aspiration System is a single-use over-the-wire catheter-based system for the minimally invasive treatment of thromboemboli in the peripheral vasculature and for the treatment of pulmonary embolism. The system is comprised of two main components packaged separately: Triever Catheters (available in 3 sizes: 16, 20, and 24 Fr) FlowTriever Catheters (available in 4 sizes: 6-10 mm, 11-14 mm, 15- 18 mm, and 19-25 mm) Triever Catheters are inserted and advanced to the thrombus over a pre-placed 0.035" guidewire. After removal of its dilator, thrombus may be removed by aspiration with the provided 60 cc VacLok Vacuum syringe. After the procedure is complete, the Triever Catheter is removed from the patient.

The provided document is a 510(k) summary for the Triever Catheters. It describes a device modification to include "clot in transit in the right atrium" in the Indications for Use (IFU) statement. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove they are met in a quantitative manner typical of performance studies for AI software.

However, based on the information provided, we can extract the following:

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

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

• Sample Size: Clinical data was collected and evaluated for 47 patients.
• Data Provenance: The nature of the study (evaluating use of Triever Catheters in the right atrium from approximately 7,650 venous thromboembolism procedures performed) suggests this data is retrospective, compiled from existing patient records where the device was used in this specific scenario. The country of origin is not specified, but the submission is to the FDA, suggesting a US context or data relevant to US regulatory standards.

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

The document does not specify the number of experts or their qualifications for establishing ground truth. The assessments appear to be based on clinical outcomes and "Inari Account Managers' assessment of clinician satisfaction."

4. Adjudication method for the test set

The document does not describe an adjudication method. The clinical data appears to be a review of outcomes from actual patient cases.

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, an MRMC comparative effectiveness study was not done. This study is focused on the safety and effectiveness of a medical device (catheter) for a specific indication, not on the performance of an AI algorithm or human reader improvement with AI assistance.

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

No, this document describes a medical device (catheter), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.

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

The ground truth for effectiveness (clot removal) appears to be based on outcomes data from patient treatments and possibly clinical assessment during or after the procedure. For safety, it relies on the absence of reported adverse events like heart damage.

8. The sample size for the training set

This document does not describe the development or training of an algorithm, so there is no mention of a training set sample size.

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

Not applicable, as no algorithm training set is described.

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