(21 days)
Force Fiber® Black Co-Braid Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries.
The Force Fiber® Black Co-Braid Polyethylene is non-absorbable, sterile, surgical suture composed of ultra high molecular weight polyethylene (UHMWPE). It is available in sizes 5-0 through 5, meeting USP requirements except for oversized diameter.
The provided document is a 510(k) summary for a surgical suture and does not describe acceptance criteria, performance studies, or ground truth establishment for an AI/ML powered medical device. Therefore, I cannot extract the requested information from this document.
The document pertains to a physical medical device (suture) and discusses its substantial equivalence based on:
- Detailed device description: Composition (UHMWPE for Force Fiber Black Co-Braid Polyethylene), availability in sizes 5-0 through 5, and meeting USP requirements except for oversized diameter.
- Performance testing: All sizes tested according to USP 30 for Knot Pull Tensile Strength, Needle Attachment, and Diameter, meeting the Class II Special Controls Guidance for Surgical Sutures (June 3, 2003).
- Conformance with voluntary performance standards: ISO 10993-1:2003 for biological qualification safety tests of materials.
The review of the provided text confirms that it is a 510(k) submission for a non-AI/ML surgical suture. Therefore, the requested information regarding AI/ML device acceptance criteria, study details, and ground truth establishment is not present.
§ 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.