(214 days)
Intended Use: The Vesocclude Polymer Ligation Clips are in procedures involving ligation of vessels or tissue structures. Surgeons should apply the appropriate size of the vessel or tissue structure to be ligated such that the clip completely encompasses the vessel or tissue structure.
The Vesocclude™ ligating clips are non-absorbable, nonactive implantable devices to be used for ligation of vessels and tissue structures. The clips are made of acetal homopolymer and are offered in three sizes; medium/large, large and x-large. Each clip size is compatible with a corresponding clip applier that may be designed for either general or endoscopic procedures. The clips are supplied in quantities of six according to size in color coded cartridges that are prepackaged sterile and single-use.
The provided document is a 510(k) summary for a medical device (Vesocclude™ Polymer Ligating Clip) and does not describe AI/ML device performance or a clinical study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.
Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details as this information is not present in the provided text.
The document primarily states:
- The device is a non-absorbable, nonactive implantable clip for ligation of vessels and tissue structures.
- It is substantially equivalent to the Teleflex Medical Hem-o-lok® Ligating Clips.
- Performance testing (nonclinical) included dimensional analysis, clip applier compatibility, post aging performance, functional testing for resistance to leakage and migration, and biocompatibility testing. These tests were conducted to demonstrate equivalence to the predicate device, not necessarily to specific acceptance criteria for a novel AI/ML device.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.