(371 days)
The DeRoyal Non-Locking Bone Fixation System components are provided non-sterile. The system is intended to treat fractures of various bones, including the clavicle, scapula, iong bones, (humerus, ulna, radius, femur, tibia and fibula), small bones (metacarpals, metatarsals, and phalanges).A Screw-Plate Usage Chart is included to assist the user in selection of the appropriate screws for recommended use with each plate.
Cannulated screws included in this bone fixation system are not designed to be used with specific plates. They can be used as a stand alone fracture fixation; or in the case of compromised bone stock, they can be used in conjunction with washers.
The washer components are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces / load over a larger area when used for fracture fixation of large (long) bone and bone fragments. Additionally, the washers are intended to prevent the projection of the screw head when the screw must be inserted at an acute angle such as in ankle arthrodesis.
The wires in this system are for use in the fixation of bone fractures, for bone reconstruction or as a guide for insertion of other medical devices.
The DeRoyal Non-Locking Bone Fixation System components are provided non-sterile. The system includes various screws (Cortical, Cancellous, Cannulated, Shaft, Malleolar), plates (One Third Tubular, Compression, Reconstruction, T Plate, Semi-Tubular, Narrow Compression, Broad Compression), washers, and wires. A Screw-Plate Usage Chart is provided to assist in selecting appropriate screws for each plate. Cannulated screws can be used for standalone fracture fixation or with washers in compromised bone. Washers distribute force to prevent screw head breakthrough and prevent screw head projection at acute angles. Wires are for fracture fixation, bone reconstruction, or as guides for other devices.
I'm sorry, but the provided text from the FDA 510(k) clearance letter and associated documents for the DeRoyal Non-Locking Bone Fixation System does not contain the type of acceptance criteria and study information you are requesting regarding AI device performance.
The document is a traditional 510(k) clearance for a physical medical device (bone fixation system), which relies on substantial equivalence to a predicate device rather than performance metrics derived from a study involving AI.
Therefore, I cannot extract the following information from the provided text:
- A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for an AI-powered device.
- Sample sized used for the test set and the data provenance: Not applicable to this type of device clearance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
This document describes a conventional bone fixation system and its intended uses, including various screws, plates, and washers. Its clearance is based on its similarity to other legally marketed predicate devices, not on the performance of an AI algorithm.
§ 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.