(41 days)
The Synthes Distraction Osteogenesis System is intended for fracture fixation (open and closed), pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental bony or soft tissue defects.
The Synthes Distraction Osteogenesis System is an external ring fixation system. The system is comprised of wires and Schanz screws that are attached to rings with bolts, nuts and/or clamps; rods that interconnect the rings; and connecting plates, hinges, standoffs, posts and supports that complete the assembly of the fixator. The system components are made from nonmagnetic materials and are intended to be used in an MR environment. An MR environment is described as the general environment present in the vicinity of an MR scanner and/or anywhere in the procedure room, including the center of the bore of the MR scanner. The Synthes Distraction Osteogenesis System is a modular and versatile system that is fully customizable. An individualized frame should be constructed for each case to suit the specific situation.
I am sorry, but the provided text from the 510(k) summary for the Synthes Distraction Osteogenesis System does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data.
The document discusses:
- Device Name and Sponsor
- Classification and Predicate Devices
- Device Description (components and materials)
- Intended Use
- A statement regarding substantial equivalence to other legally marketed devices.
- Correspondence from the FDA regarding the 510(k) clearance.
It explicitly states, "Substantial Documentation is provided which demonstrates that the Synthes (USA) Distraction Osteogenesis System is substantially equivalent to other legally marketed devices." This means the product's safety and effectiveness were primarily established by comparing it to existing, legally marketed devices, rather than through a new, comprehensive performance study with acceptance criteria.
Therefore, I cannot provide the requested information, which includes:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth
- Adjudication method
- MRMC comparative effectiveness study details
- Standalone performance study
- Type of ground truth used
- 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.