(130 days)
The Flower Small and Medium Implants set is intended for use for internal fixation of fractures and reconstruction of bones, including the scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, hand and foot in adults and for use in long bones in adolescents (12-21) in whom the growth plates have fused. Examples of these internal fixations and reconstructions include compression fractures, intra-articular and extraaticular fractures, displaced fractures, osteotomies, non-unions and mal-unions.
This system can be used for palmar, ventral, dorsal or orthogonal application.
The Flower Small and Medium Implants set consists of the following components and accessories: pure titanium small straight plates, small and medium reconstruction plates, medium osteosynthesis plates, proximal humerus plates, distal radius plates, T-plates, angular T-shaped plates, H-shaped plates, mediocarpal plate; and titanium alloy screws. The device is also provided with general purpose instruments. All plates are made of pure titanium (ISO 5832-2).
The Flower Small and Medium Implants set provides fixed-angle lockable screws and plates to assist with internal fixation of fractures and reconstruction of bones. The principles of operation of the device are similar to other bone plating systems. The plates are comprised of various shapes. alignments, thicknesses, widths, and lengths designed to contour to different bones and locations on the body for internal fixation or reconstruction following fracture. .Each of the plates contains several locking holes that allow for the insertion of Flower Small and Medium Implants locking screws. To use the Flower Small and Medium Implants set, the surgeon first selects an implant of the appropriate size and shape based on the intended site of use. The plate should be placed in an appropriate location on the given bone or anatomical location in need of repair.
The provided text describes a 510(k) premarket notification for the "Flower Small and Medium Implants" a bone plating system. It details the device's intended use, technological characteristics, and compares it to predicate devices to establish substantial equivalence.
However, the document does not contain information related to acceptance criteria, diagnostic performance metrics (like sensitivity, specificity, AUC), or a study design to measure these. The "Performance Data" section lists only:
- Biocompatibility testing (ISO 10993-1, ISO 10993-5)
- Sterilization validation
- Packaging validation and shelf life testing
These are general safety and manufacturing aspects, not data on the clinical or diagnostic performance of the device in the context of typical AI/software-as-medical-device studies. The device is a physical orthopedic implant, not an AI or software device that would have metrics like sensitivity or specificity.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding sample sizes, ground truth establishment, expert adjudication, or MRMC studies for diagnostic accuracy, as this information is not present in the provided 510(k) summary.
The summary states: "Engineering analysis has been performed to demonstrate that the Flower Small and Medium Implants system provides appropriate mechanical strength for its intended use." This suggests mechanical testing was done, but the specific acceptance criteria and results for this are not detailed beyond a general statement of "functional as intended."
§ 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.