(307 days)
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.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).