(169 days)
The SwirlGraft™ Bypass Graft is intended for bypass or reconstruction of occluded or diseased peripheral arterial blood vessels.
The SwirlGraft™ Vascular Access Graft is intended for use as a subcutaneous arteriovenous conduit for vascular access.
The SwirlGraft™ Bypass and Vascular Access Grafts are 6 mm diameter expanded polytetraflouro-ethylene (ePTFE) vascular grafts that are manufactured with a small amplitude helical geometry along their length. The SwirlGraft™ Bypass Graft has a thin wall ePTFE construction and a full ePTFE external support. The SwirlGraft™ Vascular Access Graft is a standard wall ePTFE construction with no external support.
The provided text refers to a 510(k) summary for a vascular graft device, not an AI/ML device. Therefore, the questions regarding acceptance criteria, study details, and AI/ML specific performance metrics like MRMC studies, standalone algorithm performance, or ground truth for training/test sets are not applicable to the information contained in this document.
The document indicates that the device's safety and effectiveness were demonstrated through:
- Bench testing: This refers to in-vitro experiments performed in a laboratory setting.
- Animal data: This refers to in-vivo studies conducted on animal subjects.
The core of the submission relies on demonstrating substantial equivalence to a predicate device (Sulzer Medica's Sulzer Vascutek ePTFE Vascular Prosthesis, K992832). This means that the technological characteristics, performance, and principle of operation of the SwirlGraft™ were found to be similar enough to the predicate device, which is already legally marketed.
Therefore, the specific quantitative acceptance criteria or detailed study results that would typically be reported for an AI/ML device are not present in this 510(k) summary. The summary states:
"Comparative testing of the SwirlGraft™ Bypass and Vascular Access Grafts with the predicate device found that the technological characteristics, performance and principle of operation were substantially equivalent."
And:
"Bench testing and animal data demonstrated that the safety and effectiveness of the SwirlGraft™ Bypass and Vascular Access Grafts is equivalent to the predicate devices."
Without further documentation, it is not possible to provide answers to the specific questions laid out in the prompt as they pertain to AI/ML device evaluation.
§ 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.”