(28 days)
The YOGA Microcatheter is intended for use in peripheral, coronary, and neuro vasculature for the intravascular introduction of interventional/diagnostic devices.
The YOGA Microcatheter is a variable stiffness, single lumen catheter designed to access small, tortuous vasculature. The catheter shaft is composed of a variable pitch stainless steel braid with a PTFE inner liner to facilitate movement of guide wires and other devices. The exterior of the catheter shaft is covered with a polymer material, which encapsulates the stainless steel braid construction. The distal end of the catheter has a radiopaque marker band and has a hydrophilic coating to provide lubricity for navigation of vessels. The proximal end of the catheter has a hub and an ID band is placed at the distal end of the hub over a strain relief. A steam shaping mandrel is provided in the package. The two new YOGA Microcatheters are provided in back up (XB) and extra backup (XXB) configurations, i.e. a stiffer distal end to provide additional support.
The provided text is for a 510(k) premarket notification for a medical device called the "YOGA Microcatheter". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through the kind of study described in the prompt.
Therefore, the document does not contain the detailed information necessary to answer the prompt's questions. The prompt is designed to elicit information about a study that assesses AI/algorithm performance (e.g., accuracy, sensitivity, specificity, or improvement in human reader performance), which typically involves a test set, ground truth experts, and statistical analysis against predefined acceptance criteria. This 510(k) submission, however, details the physical and functional characteristics of a medical catheter and demonstrates its similarity to a previously approved device through bench testing, not a diagnostic study involving AI or image analysis.
Here's why the information isn't present:
- Device Type: The YOGA Microcatheter is a physical medical device (a catheter), not a software algorithm, diagnostic imaging tool, or AI system. Its performance is evaluated through physical and functional characteristics (e.g., stiffness, trackability, biocompatibility, sterilization) rather than diagnostic accuracy metrics.
- Regulatory Pathway: A 510(k) submission seeks to establish "substantial equivalence" to a predicate device. This often involves demonstrating similar technological characteristics and performance through bench testing, not necessarily conducting large-scale clinical trials or diagnostic accuracy studies like those performed for AI/CAD devices.
- Nature of Testing: The "Performance Data" section describes "Bench Test Summary" including Linear Stiffness, Lateral Stiffness, and Track Testing. These are engineering tests, not studies involving human readers, ground truth consensus for imaging data, or AI performance metrics.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria for an AI/algorithm, sample sizes for test/training sets, expert qualifications, or MRMC studies, as this information is not present in the provided 510(k) document.
§ 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).