(83 days)
Is indicated for use for in placement of suture through soft tissue in endoscopic and other limited access procedures.
The Opus Medical SpeedStitch™ Suture Device is intended for use in endoscopic procodures as well as other limited access open procedures for the purpose of suturing soft tissues. The wen us oner minned docess open preedStitch™ is based on a hand held, manually powered suture punch for the dclivery of a suture needle through soft tissue. The device delivers a simple stitch using USP #2 braided suture.
The provided text is a 510(k) premarket notification for the Opus SpeedStitch™ Suture Device. It outlines the device's intended use and claims substantial equivalence to an existing device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, ground truth types, or training set details. This type of detailed study information is typically found in the "Performance Data" or "Clinical Data" sections of a 510(k) submission, which are not present in the provided snippets.
§ 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.