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The Benchmark BMX96 Access System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Benchmark BMX96 Access System is a three-component system comprised of the Benchmark BMX96 Delivery Catheter, Neuron 6F Select Catheter, and a Dilator. The Benchmark BMX96 Delivery Catheter can be used individually with a 0.038 in. [0.97 mm] guidewire or together with the Neuron 6F Select Catheter to access the desired anatomy.

This document describes the premarket notification (510(k)) for the Benchmark BMX96 Access System. However, it does not contain information about an AI/ML-driven medical device. Instead, it focuses on the substantial equivalence of a medical device (catheter system) to a predicate device, primarily based on bench-top performance testing.

Therefore, I cannot provide a description of acceptance criteria and a study proving an AI/ML device meets them, as the provided text pertains to a traditional medical device (catheter) and its physical performance, not an AI/ML diagnostic or prognostic system.

The closest relevant information from the provided text that could potentially be misinterpreted as "acceptance criteria and device performance" for an AI system would be:

• Bench-top Performance: "The subject device met all established requirements." and "The following bench-top performance tests were performed on the subject device and all have met acceptance criteria: Particulate Testing and Coating Integrity Testing, Simulated Use Testing."
• Biocompatibility: Stated as not requiring additional testing due to identical materials, processing, and sterilization as previously tested products.

However, these refer to the physical and material properties of a catheter, not the performance metrics of an AI/ML algorithm.

In summary, the provided text does not contain the necessary information to answer the request regarding acceptance criteria and a study proving an AI/ML device meets those criteria.

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The Benchmark BMX96 System is indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.

The Benchmark BMX96 System is a three-component system comprised of the Benchmark BMX96 Delivery Catheter, Neuron 6F Select Catheter, and a Dilator. The Benchmark BMX96 Delivery Catheter can be used individually with a 0.038 in. [0.97 mm] guidewire or together with the Neuron 6F Select Catheter to access the desired anatomy.

Benchmark BMX96 Delivery Catheter: The Benchmark BMX96 Delivery Catheter is a single lumen, variable stiffness catheter with a radiopaque marker band on the distal end and a Luer hub on the proximal end. The Benchmark BMX96 Delivery Catheter dimensions are included on the individual device label. The Benchmark BMX96 Delivery Catheter is compatible with introducer sheaths appropriately sized for the outer diameter of Benchmark BMX96.

Neuron 6F Select Catheter: The Neuron 6F Select Catheter is a single lumen, braid-reinforced, variable stiffness catheter with a radiopaque distal end and a Luer hub on the proximal end. The Neuron 6F Select Catheter is available in four tip shapes (SIM, H1, BER, or SIM-V). The Neuron 6F Select Catheter tip shape and dimensions are included on the individual device label. The Neuron 6F Select Catheter is compatible with the Benchmark BMX96 Delivery Catheter.

Dilator: The Dilator is a single lumen, radiopaque catheter with a tapered distal end and a Luer hub on the proximal end. The Dilator is compatible with the Benchmark BMX96 Delivery Catheter. The Dilator facilitates the percutaneous entry of the Benchmark BMX96 Delivery Catheter by forming an atraumatic transition from the skin through the subcutaneous tissue to the vessel.

The Benchmark BMX96 System is a single-use, ethylene oxide (EO) sterilized system.

The provided text is a 510(k) summary for the Penumbra Benchmark BMX96 System. It discusses the device's indications for use, its comparison to a predicate device, and the performance data that supports its substantial equivalence.

However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, reported device performance in a table, sample sizes, provenance of data, details about experts, adjudication methods, MRMC studies, standalone performance, or training set information.

Instead, the performance data section mentions:

• Design Verification Testing: Including dimensional/visual, friction, fluoroscopy, simulated use (flow model and vessel entry), particulate, hub air aspiration, tensile and elongation, burst, corrosion resistance, shelf life, packaging, and sterilization.
• Biocompatibility Testing: Conducted according to ISO 10993-1, USP standards, and FDA GLP, including in vitro cytotoxicity, sensitization, irritation, systemic toxicity, material-mediated pyrogen, and hemocompatibility tests.
• Conclusion: "The subject device met all established requirements." and "Biocompatibility test results demonstrate biological safety per ISO 10993 and USP requirements."

It explicitly states: "No animal or clinical study was conducted as bench testing was determined sufficient for verification and validation purposes."

Therefore, I cannot provide the requested information because it is not present in the provided text.

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