(99 days)
Force Fiber® 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 orthopedic surgeries.
Force Fiber®OrthoTape® Suture is indicated for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.
Bondek® and Bondek® Plus Synthetic Absorbable Surgical Sutures are intended for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in and neurological procedures.
Monodek Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in all types of soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. Monodek® suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.
Polyglytone*6211™ Monofilament Synthetic Absorbable Surgical Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular surgery, neurological surgery, or microsurgery.
Force Fiber Suture is a non-absorbable, sterile, surgical suture composed of Ultra High Molecular Weight Polyethylene (UHMWPE). It is available as braided undyed (white), braided blue, co-braid of white UHMWPE and blue polypropylene (PP) monofilament strands, co-braid of white UHMWPE fibers and black Nylon monofilament strands, and co-braid of white UHMWPE fibers and green polyester (PET) fibers.
Force Fiber OthoTape Suture is an uncoated braid that is flat in shape and differs from USP requirements (not USP). It is available in 1mm, 1.5mm, 2.5mm, 3.5mm, 4mm and 5mm tape sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE), or UHMWPE/ Green Polyester co-braid.
Bondek and Bondek Plus Suture is an absorbable, braided multifilament suture composed of a homopolymer of glycolic acid, polyglycolic acid. The Bondek suture material is coated with polycaprolactone-glycerol monostearate solution, and is available in green and beige (undyed) USP sizes 8-0 through 2. The Bondek Plus suture material is coated with polycaprolactone-co-polygolycolic acid, and is available in violet, green or beige (undyed) USP sized 6-0 through2.
Monodek Absorbable Surgical Suture is a monofilament suture that meets all USP requirements except for oversize diameter. Monodek is available in sizes 6-0 through 0 (metric sizes 0.7 through 3.5), undyed and dyed (violet). The suture may be supplied on ligating reels.
Polyglytone* 6211 suture, U.S.P size 2-0, is available, undyed (natural). The suture is monofilament, and may be provided with or without plegets.
The Teleflex surgical sutures are provided sterile (EO), for singe use only and may be provided in a variety of cut lengths with or without needles. A variety of attached needles are available from either 300 or 400 series stainless steel.
The provided text is a 510(k) Summary of Safety and Effectiveness for Teleflex Surgical Sutures. It details various types of sutures (Force Fiber, Bondek, Monodek, Polyglytone) and their characteristics, indications for use, and a comparison to predicate devices for substantial equivalence.
However, the document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of performance metrics for an AI/ML or diagnostic device. Instead, it focuses on demonstrating substantial equivalence to previously cleared surgical sutures, primarily through similar technological characteristics and performance rather than a specific set of acceptance criteria and a study to meet them.
The only "testing" mentioned is non-clinical testing to demonstrate an "MR Safe" claim, which is a safety characteristic, not a performance metric in the traditional sense of AI/ML or diagnostic device performance.
Therefore, I cannot extract the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types, as this information is not present in the provided text. The document describes a traditional medical device (sutures) approval process, not an AI/ML or diagnostic device.
§ 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.