(22 days)
Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.
Not Found
I'm sorry, but this document does not contain the information requested regarding acceptance criteria and device performance for an AI/ML-based medical device study.
The provided text is a 510(k) clearance letter from the FDA for an "Introducer Sheath Kit" (product code DYB). This is a physical medical device (a catheter introducer), not an AI/ML-based software device.
Therefore, I cannot extract details about:
- A table of acceptance criteria and reported device performance for an AI model.
- Sample size, data provenance, expert qualifications, or adjudication methods for an AI test set.
- MRMC studies or standalone AI performance.
- Ground truth types or training set details for an AI model.
The letter focuses on the substantial equivalence of the "Introducer Sheath Kit" to legally marketed predicate devices, and discusses general regulatory requirements for medical devices.
§ 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).