(91 days)
The Vascutek Graft Sizer Set is designed to aid the surgeon in accurately matching the size of vascular graft to the artery. The size of graft to be selected will correspond with the number indicated on the graft sizer which best fits the outside of the vessel.
The Vascutek Graft Sizer Set consists of nine individual double-ended 'C' shaped graft sizers. The nine sizers are secured within a clip and are available in a size range from 5 to 32 mm. The graft sizers are supplied sterile and are for single use only.
This document is a 510(k) summary for the Vascutek Graft Sizer Set. It does not contain the detailed information required to answer your questions about acceptance criteria, study data, ground truth establishment, or sample sizes related to AI/device performance.
The provided text focuses on:
- Device Description: What the graft sizer set is, its components, and its intended use.
- Biocompatibility: Results of biocompatibility tests for the device material.
- Substantial Equivalence: A comparison to a previously cleared device (Meadox Graft Sizer).
There is no mention of:
- Acceptance criteria for device performance (e.g., accuracy of sizing relative to actual vessel diameter).
- Any studies involving device performance data (e.g., how well it aids surgeons in matching graft size).
- Any AI or algorithm-based components.
- Human readers, experts, or ground truth establishment in the context of device performance.
- Training or test sets.
Therefore, I cannot populate the table or answer the specific questions based on the information provided in this 510(k) summary. This document is a regulatory submission for a medical device and not a performance study report.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”