(79 days)
The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including cardiovascular and coronary artery bypass grafting procedures.
The Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-CLIP consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure and facilitation of an interrupted technique. The device is fabricated from standard medical and implantable grade materials.
I am sorry, but the provided text does not contain the specific information required to complete the table and answer the questions asked about acceptance criteria and study details. The document is a 510(k) summary for a medical device (Coalescent Surgical U-CLIP™), which primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing specific performance acceptance criteria and study results in the manner requested.
The document mentions "Clinical data confirm that functional characteristics are substantially equivalent to the predicate, and fall within, both, internal specification requirements, as well as device performance expectations," but it does not provide:
- A table of specific acceptance criteria.
- Reported device performance against those criteria.
- Sample sizes for test or training sets.
- Data provenance.
- Details about expert involvement, adjudication, or ground truth establishment.
- Information on MRMC studies or standalone algorithmic performance.
Therefore, I cannot fulfill your request based on the provided text.
§ 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.