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The ER-REBOA Catheter is intended for temporary occlusion of large vessels and monitoring of blood pressure.

The ER-REBOA™ Catheter is a large vessel occlusion catheter with a dedicated lumen for pressure monitoring. The device consists of a compliant occlusion balloon with an atraumatic distal tip (P-tip™), a dual lumen catheter shaft and a hub with extension lines to provide access to each lumen. The balloon lumen is used to inflate and deflate the balloon. The arterial line lumen is used to monitor blood pressure. The catheter has a uni-body design and is designed to be used without a guidewire. A peel-away sheath is pre-loaded on the catheter shaft to ease insertion of the catheter's P-tip™ into an introducer sheath hemostasis valve. The device has an effective length of 72 cm and is compatible with 7 Fr or larger introducer sheaths. The device is a single use sterile device. The distal tip (P-tip™) eases advancement of the catheter in a blood vessel. The compliant occlusion balloon is capable of occluding vessels up to 32 mm in diameter. Radiopaque platinum iridium marker bands are located at the functional ends of the balloon to facilitate accurate balloon placement. A co-axial catheter shaft provides appropriate stiffness and a dedicated lumen for pressure monitoring distal to the balloon. Pad printed marks on the outer catheter shaft indicate distance to the center of the balloon to facilitate proper placement. The proximal end of the catheter has a hub and extension lines. The stopcocks provide control to each of the catheters two lumens. The peel-away sheath can be separated from the catheter shaft after insertion if needed.

The provided text describes the ER-REBOA™ Catheter and its substantial equivalence to predicate devices, supported by performance testing. However, it does not include acceptance criteria or specific detailed results in a format that would allow for a direct comparison table of acceptance criteria vs. reported device performance. It also lacks granular details about study methodology such as sample sizes for test sets, data provenance, ground truth establishment, or multi-reader multi-case studies, which are typically found in detailed study reports rather than a 510(k) summary.

Therefore, I cannot directly fulfill all your requests comprehensively based only on the provided input. I will extract and infer what I can from the given text and indicate where information is missing.

Here's an attempt to answer your request based on the provided document:

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

The document lists "Performance bench and in vivo (animal) testing" as having been performed to support safety and effectiveness, and concludes that "The results of these tests demonstrate that the ER-REBOA™ Catheter has been designed and tested to conform to its intended use and comparably to the predicate devices." However, specific numerical acceptance criteria for these tests and the reported device performance values themselves are not provided in this 510(k) summary. The document only lists the types of tests conducted.

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

• Sample Size for Test Set: Not explicitly stated for any of the in vitro bench tests or the in vivo animal study. The in vivo study mentions "an Acute Naïve Porcine" but does not specify the number of animals.
• Data Provenance: The in vivo study was "Performance Evaluation of the ER-REBOA™ Catheter in the Aorta of an Acute Naïve Porcine." This is an animal study, not human clinical data. The location or specific institution where these tests were performed is not provided. All tests would be considered prospective as they were specifically conducted for the device's evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The tests performed are primarily engineering and animal studies, which typically do not involve establishing "ground truth" through expert consensus in the same way as, for example, diagnostic imaging interpretation.

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

This information is not provided and is generally not applicable to the types of bench and animal 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for diagnostic devices involving human interpretation (e.g., radiology AI), which is not the nature of the ER-REBOA Catheter.

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

Not applicable. The ER-REBOA Catheter is a physical medical device (a catheter), not an algorithm or AI system. Its performance is inherent to the device itself, not an algorithm's output.

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

For the in vitro tests, "ground truth" would be established by validated measurement techniques and scientific principles (e.g., specific pressure readings, dimensional measurements, material properties). For the in vivo animal study, "ground truth" would be physiological measurements (e.g., blood pressure, vessel occlusion confirmation) obtained directly in the animal model. No expert consensus, pathology, or human outcomes data are mentioned as ground truth sources.

8. The sample size for the training set

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

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

Not applicable. As above, this is a physical medical device, not an AI/ML algorithm.

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