(26 days)
The CenterCross ULTRA LV Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.
The CenterCross Ultra LV Catheter is a sterile, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature to facilitate exchange of guidewires and other interventional devices. The CenterCross Ultra LV Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A key element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall to aid interventionalists in establishing greater support near the treatment site.
The provided text is related to a 510(k) premarket notification for a medical device called the "CenterCross Ultra LV Catheter." This document describes the device, its intended use, and its equivalence to a predicate device. It does not present acceptance criteria or a study that proves the device meets those criteria in the context of an AI/ML model's performance.
Instead, this is a regulatory submission for a physical medical device. The "testing and evaluations" mentioned are for the physical properties and performance of a catheter, not for an AI algorithm. Therefore, I cannot extract the information required for your request, as it pertains to AI/ML model evaluation.
Specifically, the document does not contain:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Sample sizes for a test set or data provenance for an AI/ML model.
- Information about experts establishing ground truth for an AI/ML model.
- Adjudication methods for an AI/ML model.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study for an AI/ML device.
- Standalone performance of an AI algorithm.
- The type of ground truth used for an AI/ML model.
- Sample size for a training set of an AI/ML model.
- How ground truth for a training set of an AI/ML model was established.
The "testing and evaluations" section refers to bench testing for the physical catheter (Dimensional Inspection, Expansion Force, Simulated Use, Leak, Torque Strength, Tensile Strength), which are standard tests for medical devices of this type, not AI/ML performance metrics.
§ 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).