(118 days)
Turnpike catheter is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and to subselectively infuse/deliver diagnostic and therapeutic agents.
The Turnpike catheter is a single lumen catheter designed for use in the coronary and/or peripheral vasculature. The shaft is constructed of two polymer layers that encapsulate a braid and a dual-layer coil. Turnpike has a radiopaque tip (polymer or gold-plated) and is available in various tip and shaft configurations and one of three working lengths. Turnpike catheter is hydrophilic coated and is compatible with 0.014" guidewires and 5F guide catheters.
The provided document is a 510(k) premarket notification for a medical device (Turnpike Catheter). It describes the device, its intended use, and a comparison to predicate devices to demonstrate substantial equivalence.
However, the document does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/software as a medical device (SaMD) context.
The document describes mechanical and biocompatibility tests performed for the Turnpike Catheter to demonstrate its safety and effectiveness compared to predicate devices. These are standard tests for physical medical devices, not for AI/SaMD.
Therefore, I cannot populate the requested table and answer the questions related to AI/SaMD performance. The document does not describe:
- A table of acceptance criteria and reported device performance for an AI/SaMD.
- Sample sizes, data provenance, or ground truth establishment for a test set in the context of AI/SaMD.
- Number/qualifications of experts or adjudication methods for AI/SaMD ground truth.
- MRMC or standalone studies for AI/SaMD.
- Training set details for an AI model.
The document states that "Verification and validation test results met the specified acceptance criteria and did not raise new questions of safety or effectiveness issues." However, it does not list those acceptance criteria or the specific results in a format relevant to AI/SaMD. It broadly mentions mechanical tests (e.g., working length, radiopacity, torque) and biocompatibility tests (e.g., cytotoxicity, hemolysis), which are entirely different from the performance metrics expected for AI algorithms (e.g., sensitivity, specificity, AUC).
§ 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).