(254 days)
ferroFibre 14 Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.
The ferroFibre™ Stainless Steel Suture is available in United States Pharmacopocia (USP) sizes 5-0 to #5 in various lengths. The ferroFibre multifilament stainless stecl sutures are supplied storile, armed with cutting needles. The sutures are fabricated from 316 stainless steel that meets ASTM F138-03.
The provided text describes a 510(k) submission for the ferroFibre™ Stainless Steel Suture. This document focuses on the regulatory clearance for a medical device and does not contain information about an AI/ML powered device, nor does it detail a clinical study with acceptance criteria and reported device performance in the way requested.
The document outlines performance testing conducted to characterize biocompatibility, diameter, and tensile strength according to ISO 10993 standards and USP Monographs. However, it does not provide specific acceptance criteria or reported performance values for these tests. It also does not include details on sample sizes for testing, ground truth establishment, expert involvement, or any multi-reader multi-case (MRMC) studies, as these types of studies are not relevant for the regulatory approval of a non-AI/ML surgical suture device.
Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance and clinical study design for this submission. The content is about a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence to existing products.
§ 878.4495 Stainless steel suture.
(a)
Identification. A stainless steel suture is a needled or unneedled nonabsorbable surgical suture composed of 316L stainless steel, in USP sizes 12-0 through 10, or a substantially equivalent stainless steel suture, intended for use in abdominal wound closure, intestinal anastomosis, hernia repair, and sternal closure.(b)
Classification. Class II (special controls). The device, when it is a steel monofilament suture that is uncoated and does not incorporate barbs, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9. 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.