(101 days)
The Arthrex VAL KreuLock™ Compression Screws (2.7 mm solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7) and Distal Radius Plates.
The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.
The Arthrex VAL Screws (2.7 mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions, in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.
The Arthrex VAL Screws (3.5 mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.
The Arthrex SS VAL KreuLock™ Compression Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The screws are sold single-use and non-sterile.
The Arthrex SS VAL Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 8 mm to 110 mm. The screws are sold single-use and non-sterile.
The provided text describes mechanical performance testing for a medical device and not an AI/ML powered device, therefore the information required to answer the questions for an AI/ML powered device is not available.
The device in question, the "Arthrex SS VAL and VAL KreuLock™ Compression Screw System," is a physical medical device (fracture fixation screws) and the performance data described relates to mechanical properties (pull-out, compression, torque, etc.) and MRI compatibility. There is no mention of any AI/ML components, software algorithms, or clinical performance metrics typically associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC).
Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of AI/ML, nor can I answer questions regarding sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for a training set was established. These categories are specifically designed for the evaluation of AI/ML-powered devices.
§ 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.