(316 days)
The Core Orthopaedics bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones. including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia, phalanges, carpals, metacarpals, tarsals, metatarsals and fibula. The washers are to function with screws to prevent the screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates, screws, and washers are a one-piece device made of stainless steel.
This 510(k) summary describes a traditional device, not an AI/ML powered device. Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics is not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices (K110086 and K052483) based on design, material, dimensional comparison, and intended use for bone fragment fixation plates, screws, and washers.
Summary of Device and Performance Information Provided:
- Device Name: Bone Fragment Fixation Plates, Screws and Washers
- Intended Use: Internal fixation of bone fractures, fusions, or osteotomies in various anatomical locations (ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bones, and small bones). Washers are intended to prevent screw heads from breaking through the cortex by distributing forces.
- Material: Stainless steel
- Sterilization: Distributed non-sterile, to be sterilized by the end-user per AAMI guidelines to achieve a Sterility Assurance Level (SAL) of 10^-6.
- Performance Data: The submission states that the device is "substantially equivalent to the predicate devices with respect to design and material and dimensional comparison." This indicates that the performance criteria implicitly align with those of the predicate devices. No specific quantitative performance metrics or studies directly related to acceptance criteria for the new device are provided, as substantial equivalence is the primary pathway.
The following information is NOT available in the provided text, as it pertains to AI/ML powered devices and studies, which this device is not:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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.