(90 days)
The Amplatzer™ Steerable Delivery Sheath is indicated to facilitate the delivery of the Amplatzer Amulet Left Atrial Appendage Occluder.
The Amplatzer Steerable Delivery Sheath is a sterile (EO), single use sheath designed to provide a pathway through which a device may be delivery sheath is available in one size, 14F. The sheath will be used to deliver an Amplatzer Amulet™ Left Atrial Appendage Occluder. The Amplatzer™ Steerable Delivery Sheath is comprised of three components: a sheath to deliver the device, a dilator to ease penetration of tissue, and a 2X to 1X Flush Adapter to facilitate connection of additional device components.
The sheath is comprised of the distal tip, sheath body and sheath handle. The distal tip design utilizes a dual fixed curve in two dimensions, resulting in a three-dimensional geometry. The sheath body is radiopague for visibility under fluoroscopy and includes a marker band located in the distal tip to aid with visualization during device deployment and recapture. The Steerable Sheath device has been designed with a bi-directional distal tip which is controlled by pull-wires along the sheath body connected to the device handle to provide better co-axial alignment between the appendage and sheath. Additionally, a hemostasis valve and side port are integrated in the device handle. The sheath has an effective length of 75 cm and 98.5 cm overall length. The sheath is compatible with a 0.35″ guidewire and a 19F introducer.
The provided text describes a submission for a medical device called the Amplatzer™ Steerable Delivery Sheath, but it does not contain acceptance criteria for an AI/ML powered device or a study proving its performance against such criteria.
The document is a 510(k) summary for a traditional medical device (a catheter delivery system) and focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing. It includes information on biocompatibility, bench testing, sterilization, packaging, and a design validation study in an animal model.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria or an AI/ML-specific study.
Here's why the document doesn't fit your request:
- No AI/ML Component: The Amplatzer™ Steerable Delivery Sheath is described as a physical medical device (catheter) used to deliver another device. There is no mention of any artificial intelligence or machine learning component in its design or function.
- Focus on Substantial Equivalence: The entire submission is built around demonstrating that the new device is "substantially equivalent" to existing predicate devices, which is a standard regulatory pathway for non-novel medical devices. This typically involves comparing design, materials, indications for use, and performance through established test methods, not AI model metrics.
- Study Types: The studies mentioned (biocompatibility, bench testing, animal model design validation, human factors) are typical for hardware medical devices and do not involve AI performance evaluation metrics (e.g., accuracy, sensitivity, specificity, AUC).
If you have a document describing an AI/ML device, I would be happy to analyze it against your criteria. This document, however, does not contain that information.
§ 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).