(58 days)
The Thinline Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
The Thinline Introducer Sheath is a single-lumen, coil-reinforced catheter. The Thinline Introducer Sheath is available in 11cm and 23cm lengths (French size 9F) and is designed to accept 0.038 inch diameter quide wires. A radiopaque outer laver is included for angiographic visualization. A valved hub with integrated suture ring is attached to the proximal end with extension tubing and a three way stop cock which allows attachments for flushing and aspiration. This catheter is designed for use in providing access and facilitating the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The dimensions for the Thinline Introducer Sheath are indicated on the product label. A dilator and guidewire accessory are included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.
The provided document is a 510(k) Premarket Notification for a medical device called the "Thinline Sheath Introducer." This document details the device's characteristics, indications for use, and the testing conducted to demonstrate its substantial equivalence to a predicate device.
Crucially, this document is for a physical medical device (a catheter introducer) and contains no information about an AI/ML-driven device or its acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).
Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria for an AI/ML device, such as sample sizes for test sets, data provenance, expert ground truth establishment, MRMC studies, or standalone performance. The performance data presented in the document (Table 6.2) relates to physical and functional tests of the sheath introducer, such as tensile strength, burst pressure, and sterility, not AI algorithm performance.
If you can provide a document that discusses an AI/ML-driven medical device and its validation study, I would be able to answer your questions.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).