(90 days)
The Acumed Cannulated Screw System consists of screws, washers, and accessories and is generally intended for fixation of fracture, fusion and osteotomies of large and small bones appropriate for size of device, which may include the following: Minimally invasive reconstruction of fractures and joints; Adjuvant for osteosynthesis in complex joint fractures; Multifragment joint fractures: Simple metaphyseal fractures of the wrist, ankle, elbow, and shoulder; Condylar fractures; Epiphyseal and metaphyseal fractures in children; Osteochrondritis dissecans; Ostero-Chondral Fractures; Ligament avulsion injuries; Ligament fixation; Other small fragment, cancellous bone fractures; Small joint fusion; Areas where accurate screw placement is vital; Metatarsal and phalangeal osteotomies; Fractures of the tarsals, metatarsals and other fractures of the foot; Avulsion fractures and fractures of metatarsal V; Tarso-metatarsal and metatarso-phalangeal arthrodesis; Tarsal Fusions; Calcaneal and talar fractures; Subtalar arthrodesis; Ankle arthrodesis; Fractures of small joints, such as: Ankle fractures, Navicular fractures of the fibula, malleolus, and calcaneus; Distal tibia and pilon fractures; Acetabular fractures; Other fractures of the pelvic ring; Sacroiliac joint disruptions; Fractures of the femoral head and neck; Supracondylar femoral fractures; Slipped capital femoral epiphyses: An adjunct to DHS in basilar neck fractures; Pediatric femoral neck fractures; Intercondylar femur fractures; Intracapsular fractures of the hip; Fractures of the distal femur and proximal tibia; Patellar fractures; Tibial plateau fractures; Small fragments of the hand and wrist; Fractures of the carpals and metacarpals; Carpal and metacarpal arthrodesis; Scaphoid fracture and other fractures of the hand; Phalangeal and interphalangeal fractures; Fractures of the ulna and radius; Radial head fractures; Fractures of the olecranon and distal humerus; Humeral head fractures; Ligament fixation at the proximal humerus; and Glenoid fractures. Washers may be used with the screws in certain applications.
The Acumed Cannulated Screw System consists of screws, washers, and accessories used for fixation of fracture, fusion and osteotomies of large and small bones appropriate for the size of the device.
Screws are available in a variety of diameters and lengths to accommodate various indications and patient anatomy. All screws and washers are made of titanium alloy per ASTM F136. Screws range in diameter from 3.0mm to 7.3mm and in lengths from 8mm to 150mm.
All implants are provided sterile and non-sterile.
The provided document is a 510(k) summary for a medical device (Acumed Cannulated Screw System), not a clinical study report. Therefore, it does not contain information about acceptance criteria for device performance, a study proving the device meets those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement as requested.
The document primarily focuses on establishing "substantial equivalence" of the Acumed Cannulated Screw System to legally marketed predicate devices, as required for 510(k) clearance by the FDA. This process relies on demonstrating that a new device is as safe and effective as pre-existing, legally marketed devices.
Specifically, the document mentions:
- Non-clinical Testing: "The non-clinical testing included in this submission includes testing to ASTM F543." This indicates that the device underwent engineering/material testing according to an industry standard, but it doesn't provide performance metrics against acceptance criteria for clinical outcomes nor details of a study with human subjects or expert assessment.
- Substantial Equivalence Comparison: A table compares the Acumed system to predicate devices based on material, diameter, length, cannulation, and sterility. The conclusion states, "There are some differences, but none of them raise new issues of safety or effectiveness. The Acumed Cannulated Screw System is substantially equivalent to the predicate devices."
Therefore, I cannot provide the requested information because the document does not contain a study that describes acceptance criteria or provides performance data in the context of a clinical or analytical validation study involving human data, expert review, or ground truth establishment.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.