(269 days)
Advanta VXT and Flixene vascular grafts are indicated for use in patients with peripheral vascular disease, where peripheral arteries must be repaired or replaced and open surgery is required. Indications for use also includes patients with end stage renal disease requiring arteriovenous vascular access for dialysis.
Atrium ePTFE vascular grafts are offered in a variety of designs; (including Advanta VXT and Flixene). They are made primarily of expanded polytetrafluoroethylene (ePTFE), and are available in a wide variety of configurations:
- . "Rings" (also referred to as "helix") for added radial support (made from a PTFE monofilament coil)
- . The Slider Graft Deployment System consisting of a pre-attached tip(s) with a clear flexible sheath (polyethylene)
- . Tapered end
- . Thin or standard wall thickness
The Advanta VXT graft is a 2-layer graft employing a single-layer ePTFE graft, which is then wrapped with an additional layer of ePTFE for increased support. The rings available on some Advanta VXT grafts are bonded to the exterior surface of the graft. By following the prescribed procedure, the rings can be removed incrementally as needed. The Flixene vascular graft is a 3layer graft comprised of ePTFE. This graft was designed with an additional layer of ePTFE. As a result of its design, ring support is not necessary. Implantable portion of graft is comprised of polytetrafluoroethylene (PTFE) with no more than 0.1% cobalt chromite blue-green Spinel ink on surface of the graft, which is used as a reference line. Additional materials in transient contact during placement of the graft include 303 stainless steel and polyethylene, which represents the graft deployment system and transfer sleeve.
The provided text is a 510(k) premarket notification for a medical device (vascular grafts) and does not contain information related to an A.I./algorithm-driven device or study. Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an A.I. device from this text.
The document focuses on demonstrating substantial equivalence of the Advanta VXT and Flixene Vascular Grafts to previously cleared predicate devices, primarily through non-clinical bench testing. It explicitly states: "There were no clinical studies of the modified device." and "The Advanta VXT and Flixene Vascular Grafts are substantially equivalent to the predicate devices in the fundamental scientific technology of the device. The design verification and validation testing established that the Advanta VXT and Flixene Vascular Grafts are substantially equivalent to the predicate devices."
As such, I cannot provide:
- A table of acceptance criteria and reported device performance for an AI/algorithm.
- Sample sizes for a test set or data provenance for an AI/algorithm.
- Number of experts or their qualifications for establishing ground truth for an AI/algorithm.
- Adjudication methods for an AI/algorithm test set.
- MRMC comparative effectiveness study results for AI assistance.
- Standalone performance of an algorithm.
- Type of ground truth for an AI/algorithm.
- Sample size for a training set for an AI/algorithm.
- How ground truth for a training set was established for an AI/algorithm.
§ 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.”