(98 days)
The Anchorage™ Closure Device facilitates placement of a pre-tied ligature for use in surgical applications where soft tissue must be approximated and/or ligated.
The Anchorage Closure Device is a one piece, single-use system comprised of components used to deliver and deploy a pre-tied suture in order to achieve soft tissue approximation and/or ligation.
I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving that the device meets them. The document is a 510(k) summary for the Epitek Anchorage™ Closure Device, focusing on its substantial equivalence to predicate devices, its description, and its indications for use. It primarily constitutes regulatory correspondence from the FDA.
Therefore, I cannot fulfill your request for the tables and details about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.