(144 days)
The VersaCross Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
The VersaCross™ Transseptal Sheath is a sterile, single-use introducer catheter device. The device is comprised of a sheath (VersaCross™ Sheath), a dilator (VersaCross™ Dilator) and a j-tipped quidewire.
The VersaCross™ Transseptal Sheath is designed for catheterization and angiography of specific heart chambers and locations. It is used in catheterization procedures primarily by Electrophysiologists and Interventional Cardiologists. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment. including fluoroscopy and echocardiography under sterile technique.
This document describes the 510(k) summary for the VersaCross Transseptal Sheath. This is a medical device, and the information provided details its technical specifications and comparison to a predicate device, rather than a study and acceptance criteria for an AI/ML powered device. Therefore, I cannot extract the information required for the prompt as it is not present in the provided text.
The prompt specifically asks for details about a device's performance based on a study that proves it meets acceptance criteria, including elements like:
- Table of acceptance criteria and reported device performance
- Sample size for test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results
- Standalone performance
- Type of ground truth
- Sample size for training set
- Ground truth for training set
The provided text details mechanical, physical, biocompatibility, sterilization, packaging, and pyrogen testing for a physical medical device (a catheter introducer sheath). It concludes that "All test requirements were met as specified by applicable standards and the test protocols," and lists various ISO standards. This is a statement of compliance with engineering and material standards for a physical product, not a study evaluating the performance like an AI/ML algorithm would undergo.
Therefore, the requested information (related to AI/ML device study parameters) cannot be extracted from this document.
§ 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).