(55 days)
Force Fiber™ Polyethylene Nonabsorbable Surgical Sutures are indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Force Fiber Nonabsorbable Surgical Suture meets all USP requirements for size 2-0. All other sizes meet USP requirements except for oversized diameter. Force Fiber Nonabsorbable Suture is available in size 2-0 through 2 (metric size 3 through 5) and is provided as undyed (white). The suture is a braided multifilament, is provided in a variety of lengths, with or without needles, with or without pledgets, and may be supplied in a variety of cut lengths or on ligating reels.
The provided text is a 510(k) Summary for a medical device called "Force Fiber™ Polyethylene Nonabsorbable Surgical Suture." This document focuses on demonstrating substantial equivalence to a predicate device and does not contain information about the acceptance criteria and a study proving device performance as requested.
Therefore, I cannot provide the requested information from the given text. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number or qualifications of experts used for ground truth.
- Adjudication method.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Information on a standalone algorithm performance study.
- Type of ground truth used (e.g., expert consensus, pathology, outcome data).
- Sample size for the training set.
- How ground truth for the training set was established.
§ 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.