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The LANDMARK REBOA Catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

The LANDMARK REBOA Catheter is a 67cm, 59cm working length, 6.5 Fr (2.2mm), single lumen balloon catheter for temporary intravascular vessel occlusion in patients requiring emergency control of hemorrhage. Radio-opaque markers are provided on the catheter shaft at the proximal and distal ends of the balloon for radiological location of the device is additionally provided with depth markings referenced from the balloon to provide positioning information similar to the predicate device prior to confirmation of placement through radiological means. The device is intended to be deployed through a 7F introducer sheath placed into the femoral artery through normal vascular access procedures.

The LANDMARK REBOA Catheter consists of five elements:

• . Occluder Balloon Inflation Lumen with female luer (DEHP free PVC)
• Catheter Handle (PA 12)
• Catheter Shaft (polyimide and stainless steel) with Marker Bands (stainless steel)
• Occluder Balloon (polyurethane)
• Guide J-tip (stainless steel, nitinol, acrylic) ●

The provided text is a 510(k) summary for the LANDMARK REBOA Catheter. While it outlines non-clinical testing performed to establish substantial equivalence to a predicate device, it does not contain information about studies involving human readers, AI assistance, or the use of expert consensus for ground truth. This device, a physical medical catheter, is evaluated based on its physical performance characteristics and biocompatibility, not on diagnostic accuracy derived from image analysis or human interpretation.

Therefore, many of the requested points regarding acceptance criteria and studies would not be applicable in this context. The document focuses on demonstrating that the new device performs comparably to a legally marketed predicate device through bench testing and an animal model, rather than validating a diagnostic algorithm's performance.

Here's an attempt to answer the applicable points based on the provided text, with an explanation for the missing information:

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

The document doesn't present a specific table of "acceptance criteria" with quantitative performance metrics for each test in the way one might for a diagnostic AI. Instead, it states that "Performance bench testing was conducted to ensure that the LANDMARK REBOA Catheter met the applicable design and performance requirements throughout its shelf life, verify conformity to applicable standards, and demonstrate substantial equivalence to the predicate system."

The tests performed and implicitly, the criteria for passing them, are:

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

• Test Set Sample Size: Not explicitly stated for each bench test. The "In Vivo Testing" mentions an "acute Porcine model," implying a number of animals were used, but the specific count is not provided.
• Data Provenance: The bench testing and simulated use are laboratory-based, not patient data. The In Vivo testing was conducted using a Porcine (pig) model. The country of origin for the data is not specified, but the company is based in Salt Lake City, Utah, USA. The studies are prospective in nature, as they involve testing the manufactured device.

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

Not applicable. This device is a physical medical instrument, and its performance is assessed through engineering and biological in-vivo tests, not through expert interpretation of images or other data for diagnostic accuracy. "Ground truth" for this type of device relates to its physical performance meeting specifications (e.g., does the balloon burst at X pressure, does it occlude the vessel completely).

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

Not applicable. As this isn't an algorithm or diagnostic study relying on human interpretation or consensus, there's no adjudication process as described (e.g., for reconciling differing expert opinions).

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 device does not involve AI assistance for human readers or interpretation of medical images.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for the device's performance in engineering and biological tests is derived from:

• Pre-defined engineering specifications and standards (e.g., pressure tolerances, material properties, dimensional accuracy).
• Observed physical and physiological responses in the animal model (e.g., successful occlusion, lack of damage to vessel walls, device integrity after deployment).
• Compliance with recognized standards like ISO 14971:2019 (risk analysis) and ISO 10993 (biocompatibility).

8. The sample size for the training set

Not applicable. This device is not an AI model requiring a training set.

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

Not applicable. This device is not an AI model.

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