(126 days)
RiverBond, RiverSilk, RiverPro, and RiverLon non-absorbable sutures are intended to be used for soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological procedures.
HS Fiber non-absorbable suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.
Riverpoint Medical non-absorbable surgical sutures are medical devices used to secure tissues together or create wound closures during a surgical procedure or after an injury. They are composed of the applicable suture material and a standard medical grade suture needle as applicable (sutures can be provided without needles as well).
The provided text describes a 510(k) summary for Riverpoint Medical's non-absorbable surgical sutures. It outlines the device description, intended use, and states that the sutures are designed to meet specific safety and effectiveness criteria. However, it does not contain a study report with specific acceptance criteria or performance data in the format requested.
The document states:
"Riverpoint Medical non-absorbable sutures have been designed to meet the requirements for diameter, tensile strength, and needle attachment strength as specified within USP 32. Testing is performed on each lot of product to verify that USP requirements have been met prior to release."
This sentence indicates the acceptance criteria are based on USP 32 standards for these parameters. However, the document does not provide a table with these specific USP 32 requirements or the reported device performance against them. It also does not include information about sample sizes, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance studies, training sets, or how ground truth for training was established.
Therefore, I cannot populate the table or provide the detailed study information as requested. The document confirms that testing is performed to verify compliance with USP 32, but it does not present the results of such testing or the study design in a way that allows for the extraction of the requested metrics.
§ 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.