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The AngioVac F18 85 is indicated as a venous drainage cannula for the non-surgical removal of thrombi or emboli during extracorporeal bypass for up to 6 hours.

The AngioVacF1886 is a venovenous cannula with a nitinol basket reinforced, self-expandable funnel shaped distal tip collapsed using an over-sheath that can be advanced through a 22 Fr sheath and over a guidewire into the venous system percutaneously or via a surgical cut-down. During use, the cannula is connected to an extracorporeal circuit, an AngioVac Circuit, a commercially available centrifugal pump and bubble trap. A commercially available reinfusion cannula is placed for venous return (tvpically within internal jugular or one of the common femoral veins) and connected to the extracorporeal circuit. The funnel tip is actuated by advancing the AngioVac F188 out of the sheath deploying the self-expanding nitinol reinforced funnel shaped tip angle. Once optimal flow rate is achieved, the AngioVac F1885 is advanced under image guidance towards the undesirable intravascular (i.e. thrombus or emboli) until it is engaged, suctioned into the cannula and removed from the vasculature. The blood is then circulated though the filter and returned to the venous return cannula. A benefit of the AngioVac F1805 is that it allows for removal of thrombus and embolic material, while minimizing blood loss via recirculation of blood through a standard extracorporeal (venovenous) bypass circuit. Target vessels for the thrombus/embolus extraction include but are not limited to, the iliofemoral vein, Inferior Vena Cava (IVC), Superior Vena Cava (SVC) and Right Heart. The device is provided in an ~85° (AngioVac F1885) angled configuration.

Here's an analysis of the provided text regarding acceptance criteria and the study:

The provided FDA 510(k) summary (K212386 for AngioVac F18 85) does not describe a study involving an AI/Machine Learning device or a human-in-the-loop performance evaluation. Instead, it focuses on demonstrating substantial equivalence to a predicate device (AngioVac Cannula C20 and C180, K190594) through non-clinical bench testing and biocompatibility assessments.

Therefore, most of the requested information regarding AI device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment in that context is not applicable to this document.

However, I can extract information related to the device's performance based on the bench testing conducted.

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing)

The document describes various performance tests conducted to support the substantial equivalence of the AngioVac F18 85. For these types of medical devices, "acceptance criteria" are generally that the device performs as intended and meets established engineering specifications, often validated against the predicate device's performance or industry standards. The text states that the device "met all specified design and performance requirements."

Here's a table summarizing the areas of performance evaluated:

Addressing Other Requested Information (and why some are not applicable):

1. Sample size used for the test set and the data provenance: Information is not provided in a way that relates to an "AI test set." The performance data refers to bench testing of the physical medical device. The exact number of samples for each specific bench test (e.g., how many cannulas were tested for tensile strength) is not stipulated, but the nature of bench testing implies multiple physical units were subjected to these tests. No separate "test set" in the context of data for an algorithm is described.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document does not describe a study where human experts established ground truth for an algorithm. Device performance was assessed against engineering specifications and industry standards during bench testing.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as there is no "test set" in the context of an algorithm requiring expert adjudication.
4. 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 document describes a physical medical device, not an AI-assisted diagnostic tool or system that would involve human readers.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is about a physical medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the bench testing, the "ground truth" would be engineering specifications, validated test methods, and industry standards (e.g., ISO 10993 for biocompatibility) that define acceptable performance. For the substantial equivalence, the predicate device served as the primary reference.
7. The sample size for the training set: Not applicable. There is no AI/ML training set described.
8. How the ground truth for the training set was established: Not applicable. There is no AI/ML training set described.

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