(22 days)
Duet™ and Impact™ Suture Anchors are intended for use to reattach soft tissue to bone in orthopaedic surgical procedures. The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules, to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The Duet™ and Impact™ Suture Anchors are contraindicated in 1) Surgical procedures other than those listed, 2) Conditions that may compromise Anchor fixation (osteopenic, comminuted bone, pathologic conditions in the soft tissues to be attached, etc., 3) Conditions that may retard healing (poor blood supply, past or potential infection, etc), 4) Active infection, 5) Conditions that may limit the patients ability or willingness to restrict activities or follow directions during the healing period, 6) Foreign body sensitivity to materials, 7) Patients with suspected or known allergy with implant or suture materials.
Duet™ Suture Anchor and Impact™ Suture Anchors are bioabsorbale suture anchors that are preloaded on a disposable inserter device with two non-absorbable sutures. Originally they were preloaded with non-absorbable, braided, polyester #2 sutures, one of them is green and another one is white.
Purpose of this special 510(k) premarket notification is amendment of new preloaded suture material into Duet™ and Impact™ suture anchor product lines. The new suture, Herculine is non-absorbable, braided, ultra-high molecular weight polyethylene #2 suture. In coloured version 2 filaments are replaced by blue polypropylene monofilaments Herculine suture meets USP requirements for knot tensile strength and needle attachment strength.
The provided text is a 510(k) summary for a medical device (Duet™ and Impact™ Suture Anchor) and a letter from the FDA regarding its clearance. It does not contain information about acceptance criteria, device performance, study design details (sample size, data provenance, expert consensus, adjudication, MRMC, or standalone studies), or ground truth establishment for either training or test sets.
The document primarily describes a special 510(k) premarket notification for an amendment to the existing suture anchors, specifically changing the preloaded suture material from polyester to ultra-high molecular weight polyethylene (Herculine). The core argument for substantial equivalence is that this change has no effect on the intended use, principles of operation, production, raw materials, or sterilization of the device, and that the new suture meets USP requirements for knot tensile strength and needle attachment strength.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the study that proves the device meets the acceptance criteria, as this information is not present in the given text.
The text focuses on demonstrating substantial equivalence to a predicate device based on material change and compliance with general standards rather than presenting a performance study against specific acceptance criteria.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.