(71 days)
The TightRope™ Acromioclavicular (AC) Device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex TightRope Acromioclavicular (AC) Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
The TightRope™ Acromioclavicular (AC) Device is designed as two differently sized metal buttons, both stainless steel or both titanium, and FiberWire ™ suture. The buttons are pre-threaded with FiberWire suture, looped twice through the buttonholes. Pull-through FiberWire sutures are also looped through each button.
The provided document is a 510(k) summary for the "TightRope™ Acromioclavicular (AC) Device". It focuses on establishing substantial equivalence to predicate devices rather than presenting a study that demonstrates the device meets specific acceptance criteria in terms of quantitative performance metrics.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample sizes, ground truth establishment, expert involvement, adjudication methods, MRMC studies, standalone performance), and training set details cannot be extracted from this document as it does not contain such a study.
The document primarily provides:
- Device description and intended use: The TightRope™ AC Device is designed as two metal buttons (stainless steel or titanium) and FiberWire™ suture. It's intended as an adjunct in fracture repair and specifically for fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.
- Predicate devices: K043248 (TightRope Syndesmosis Device), K023294 (Bosworth Coraco-Clavicular Screw and Washer), K041356 (Tenodesis Family), K003227 (Bio-Absorbable Corkscrew), and pre-1976 Kirschner (K) Wire.
- Substantial Equivalence Claim: The manufacturer claims the device is substantially equivalent to the predicate devices and that any design differences do not raise questions concerning safety and effectiveness.
In summary, this document is a regulatory submission for premarket notification (510(k)) and not a detailed clinical or performance study report.
§ 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.