(272 days)
Metal Cannulated Screw is indicated for internal fixation of fracture, fusion and correction of limb bone and metaphysis, hand and foot:
1)The 2.3mm No Profile Cannulated Screw is indicated for the fixing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
2)The 3.0mm No Profile Cannulated Screw is indicated for internal fixation of bone fractures of ulna, and small bones (metacarpals, metatarsals, and phalanges).
3)The 4.0mm No Profile Cannulated Screw and 4.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of small bones and small bone fragments.
4)The 5.0mm No Profile Cannulated Screw and 5.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, and the bones of the hand and foot.
5)The 7.0mm No Profile Cannulated Screw and 7.0mm No Profile Cannulated Screw, Oblique are indicated for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capiplysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
6)The Headless Cannulated Screw (2.5-4.5mm)/Headless Compression Screw (2.5-4.5mm) are indicated for fixation of fractures in large bones of humerus, ulna, radius, tibia and fibula, and small bones of the foot. These screws are also indicated for intra-articular fractures of knee and ankle joint.
7)The Headless Cannulated Screw (5.0-7.0mm)/ Headless Compression Screw (5.2-7.0mm) are indicated for fixation of fractures of femur, tibia and calcaneus, and intra-articular fractures of knee joint.
8)The 3.5mm/4.0mm Headless Compression Screw, Oblique are indicated for fixation of bone fractures or for bone reconstruction of the foot and hand, including calcaneus, talar, navicular, metacarpals, metatarsals and phalanges.
9)The 6.5mm Cannulated Screw are intended for fixation of fractures, non-unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot. These screws are also indicated for femoral neck fractures, slipped capital femoral epiphysis, an adjunct to DHS (Dynamic Hip System) in basilar neck fractures, tibial plateau fractures, ankle arthrodesis, intercondylar femur fractures, SI joint disruptions and subtalar arthrodesis.
10)The 7.3mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non-unions of long bones and long bone fragments, pelvis, sacrum and the bones of the foot. These screws are also indicated for slipped capital femoral epiphysis, ankle arthrodesis and subtalar arthrodesis.
Metal Cannulated Screw consists of a series of screws with different sizes and structures, which is designed according to the anatomical characteristics of human bones. In clinical practice, Metal Cannulated Screw is used alone, which acts as a temporary internal support, provides a stable local environment for the fractured end, and creates conditions for the healing of the fractured end. Metal Cannulated Screw are made of Ti-6Al-4V ELI following ASTM F 136. Metal Cannulated Screw is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.
The provided text (K221090) describes a premarket notification for a medical device called "Metal Cannulated Screw." It details the device's indications for use, comparison to predicate devices, and non-clinical performance data.
However, the provided document does not contain any information about an AI/ML-based medical device, nor does it mention any studies involving acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, ground truth establishment by experts, adjudication methods, multi-reader multi-case (MRMC) studies, or standalone algorithm performance.
The document states: "No clinical performance data was provided to demonstrate substantially equivalence." This further indicates that the submission relies on non-clinical (mechanical and biocompatibility) testing to demonstrate equivalence to a traditional medical device (bone screws), not a software-based AI device requiring performance metrics.
Therefore, I cannot answer your request based on the provided text, as it does not contain the necessary information regarding acceptance criteria and a study proving an AI device meets these criteria.
§ 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.