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The AortaSTAT Occulsion Device is indicated for temporary vessel occlusion in the suprarenal and infrarenal aorta in applications for perioperative occlusion and emergency control of hemorrhage

The RenalPro Medical AortaSTAT Occlusion device allows continued distal perfusion of the aorta while occluding the entrance into the target side branch arteries.

The RenalPro Medical AortaSTAT Occlusion Device is comprised of a polymeric thin film membrane covering a self-expanding Nitinol scaffold connected to a stainless-steel central lumen, contained within a stainlesssteel braid-reinforced, Pebax outer shaft lined with PTFE for lubricity. The outer shaft and central lumen are attached to a deployment handle. The AortaSTAT Occlusion Device is provided sterile and non- pyrogenic and is for single patient use only.

The AortaSTAT device is delivered to the targeted vasculature location under fluoroscopy using standard endovascular techniques over a commercially available 0.018″ Guidewire. Once the device is positioned, the covered scaffold is deployed by actuating the handle to slide the outer shaft back, allowing the scaffold to expand and providing radial occlusion of the target vessel. The AortaSTAT has a radiopaque marker near the distal ends of the nitinol scaffold, and another marker encapsulated at the distal end of the outer shaft to enable visualization under fluoroscopy.

The AortaSTAT device is 8 Fr compatible in four diameters of occluding scaffolds: 19mm, 22mm, 25mm, and 28mm. The device has a 55 ± 5mm occlusive length and a 65cm working length.

The document provided is a 510(k) summary for the AortaSTAT Occlusion Device. It outlines the device description, intended use, technological characteristics, and performance data from non-clinical testing. However, it does not include specific acceptance criteria or a study that directly proves the device meets those criteria from a performance efficacy standpoint with human data. The provided document details bench testing and animal studies as part of the substantially equivalent justification for regulatory clearance, but it is not a clinical study report with detailed performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested items cannot be extracted from this document, as it primarily focuses on comparing the new device to a predicate device using non-clinical performance data and animal studies to establish substantial equivalence.

Based on the provided text, here's what can be extracted:

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

The document does not provide a table with explicit acceptance criteria for efficacy or pre-defined performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in a clinical study report. Instead, it lists the types of non-clinical tests performed to demonstrate safety and performance.

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

For the non-clinical tests, specific sample sizes are not provided. The animal study was conducted in a "swine model," which indicates an animal study, not human data. The data provenance is from laboratory testing and animal studies, not human clinical trials.

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 and animal testing, not studies involving human experts establishing ground truth for diagnostic or interventional performance.

4. Adjudication method for the test set

Not applicable. This is typically relevant for studies with human readers or evaluators, not for the types of non-clinical 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. This document pertains to a medical device (vascular clamp/occlusion device), not an AI-assisted diagnostic or interventional system, and thus an MRMC study is not relevant to the described performance evaluation.

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

Not applicable. This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" would be established by the performance standards and specifications against which the device was tested. For the animal study, the ground truth was the observable safety and performance of the device in the swine model, compared to a predicate device.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not a machine learning or AI device.

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

Not applicable for the same reason as above.

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