(57 days)
The Tandry Q-Locking Plate System is intended to provide fixation during fractures, fusions, and osteotomies. The Tandry Q-Locking Plate System is indicated for the clavicle, pelvis, scapula and calcaneus, small bones including the metacarpals, wrist, metatarsals, tarsals and phalanges, and long bones including the radius, ulna, humerus, olecranon, fibula, femur, and tibia.
Each plate is indicated for the following anatomic regions:
- 1.5mm and 2.0mm Q-locking plates: Metacarpals, metatarsals, tarsals, and phalanges
- 2.4mm Q-locking plates: Radius, wrist, and ulna
- 3.5 mm Q-locking plates: Clavicle, scapula, humerus, olecranon, pelvis, fibula, calcaneus, and tibia
- 5.0 mm Q-locking plates: Femur and tibia
The Tandry Q-Locking Plate System consists of various sized plates, screws and instruments. The plates are designed to distribute for local anatomies and can accept, cortex, shaft and cancellous, locking (variable angle) screws. The screws are designed with self-tapping to promote the operation efficiency to insert the bones. Both plate and screw feature variable angle locking design.
The provided document is a 510(k) premarket notification for the Tandry Q-Locking Plate System, a medical device used for bone fixation. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML (Artificial Intelligence/Machine Learning) device.
The document discusses the device's indications for use, technological comparison to predicate devices, and non-clinical/clinical tests performed (biomechanical tests according to ASTM F543-17) to demonstrate substantial equivalence. These tests focus on mechanical performance, not on AI/ML performance metrics such as sensitivity, specificity, or reader improvement.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device from the given text. The text does not describe an AI/ML device or its associated performance studies.
§ 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.